Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Opportunities in sterile fill/finish available based on new capacities by Simtra BioPharma Solutions

Simtra BioPharma Solutions Announces Expansion Project and Unique Opportunities

Role of Simtra BioPharma Solutions in the sterile fill/finish arena

New capacities available through Simtra based on global expansion

Sterile fill/finish opportunities to deliver better care to patients

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Sean Knight, Simtra BioPharma Solutions, reacts to the company's global expansion efforts and investment in sterile fill/finish.

Simtra BioPharma Solutions Reacts to Expansion and Unique Opportunities in the Industry

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Fabian Gerlinghaus, co-founder and CEO, Cellares

There’s no doubt that things are moving quickly in the field of cell and gene therapy. Less than a decade into market availability, there are more than 10 FDA-approved cell therapies available (1), including first-in-class tisagenlecleucel (Kymriah; Novartis), which was approved in 2017 for the treatment of acute lymphoblastic leukemia in children and young adults. Soon after, three more CD19-specific CAR T-cell therapies were approved by the FDA for the treatment of different B-cell malignancies, namely axicabtagene ciloleucel (Yescarta), brexucabtagene autoleucel (Tecartus), and lisocabtagene maraleucel (Breyanzi), and more continue to come to market for 

An August 2023 report from market research firm Roots Analysis (2) revealed that “over 1,000 cell and gene therapy candidates are currently being investigated for the treatment of various disease indications.” The report went on to say that “in order to ensure the optimum use of their resources and augment their revenue generation opportunities, a number of cell therapy companies engaged in this market offer contract services, in addition to their in-house manufacturing capabilities. In recent years, several big pharma players have undertaken initiatives, including establishing strategic partnerships, seeking investment from venture firms, and carrying out expansion projects, in order to enhance their capabilities.”

Small Footprint Automated Closed Production Platforms for CAR-T and Other Advanced Therapies

One of those companies leading the charge is San Francisco-based Cellares, a self-titled Integrated Development and Manufacturing Organization (IDMO) that provides cost savings, scalability, and drug product quality improvements versus traditional manufacturing techniques. In an interview with 

, Fabian Gerlinghaus, CEO and co-founder, Cellares, set the stage to understand what it took to innovate in a fiercely complex technology and tightly regulated space.

In the first segment of this interview, Gerlinghaus describes the scalability achieved with the Cell Shuttle platform and integrated consumable cartridge automated platform. All unit operations take place inside the single-use consumable cartridge. Cellares can load up to 16 cartridges into the Cell Shuttle, running up to 16 different processes simultaneously. According to Gerlinghaus, the Cell Shuttle reduces the amount of labor required by about 90% due to the automation, saying “it’s equivalent to about 100 different bench top instruments in one machine, in a very compact, tight space [requiring] about 90% less facility space. So, you put those two things together, a 90% reduction in labor required.” He goes on to emphasize that this results in about a 50% lower price per batch compared with conventional CDMOs. In a complex set of manufacturing operations, full automation can apparently “reduce process failure rates by about 75% compared with open and manual cell type manufacturing methods based on bench-top equipment” by greatly reducing both contamination and operator error.

Watch part 1 of our interview with Gerlinghaus below:

Fabian Gerlinghaus of Cellares discusses the company's innovative cell and gene therapy platform.

Fabian Gerlinghaus on Cellares' Platform Innovation

(1). Approved Cellular and Gene Therapy Products. US Food and Drug Administration. Updated February 21, 2024. Accessed March 6, 2024. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
(2). Top 10 Cell and Gene Therapy Companies. Roots Analysis. August 2023. https://www.rootsanalysis.com/key-insights/10-leading-cell-and-gene-therapy-companies.html

Cellares CEO Fabian Gerlinghaus shares how an automated, closed-production platform with a small footprint can dramatically impact cost savings and scalability for cell and gene therapies.

Cellares Innovates With Automated Cell and Gene Therapy Platform

Feliza Mirasol is the science editor for 

AbbVie and OSE Immunotherapeutics, a clinical-stage immunotherapy company, announced on Feb. 28, 2024 that they have entered into a strategic partnership to develop OSE-230, a monoclonal antibody (mAb) in development to treat chronic and severe inflammation. The mAb is currently in pre-clinical development.

Under the agreement, OSE Immunotherapeutics will receive a $48 million upfront payment and is eligible to receive up to an additional $665 million in clinical development, regulatory, and commercial milestones. OSE Immunotherapeutics will also be eligible to receive potential tiered royalties on global net sales of OSE-230. AbbVie will have an exclusive global license to develop, manufacture, and commercialize OSE-230.

OSE-230 is designed to activate ChemR23, a G-protein coupled receptor (GPCR) target, which may offer a new mechanism by which chronic inflammation can be resolved. Activating ChemR23 may modulate the functions of both macrophages and neutrophils, according to a company press release.

"This collaboration underscores our commitment to expanding our immunology portfolio with the ultimate goal of improving the standard of care for patients living with inflammatory diseases globally," said Jonathon Sedgwick, senior vice-president and global head of discovery research, AbbVie, in the press release. "By leveraging our expertise in immunology drug development, we look forward to advancing OSE-230, which offers a novel mechanism-of-action to treat chronic inflammation."

"We are very pleased to collaborate with AbbVie … to drive our OSE-230 program forward," said Nicolas Poirier, chief executive officer, OSE Immunotherapeutics, in the release. "This partnership represents a major milestone in our company's progress and recognizes the value of our innovative R&D capabilities. I would like to thank all our employees who helped us reach this milestone through dedication and hard work."

OSE Immunotherapeutics' pipeline also includes the following candidates:

Tedopi (immunotherapy-activating tumor-specific T-cells, off-the-shelf, neoepitope-based).

 This candidate is a cancer vaccine and is the company's most advanced product. It has generated positive results in a Phase III trial (Atalante 1) in patients with non-small cell lung cancer who are experiencing secondary resistance after checkpoint inhibitor failure. Tedopi is also in other ongoing Phase II trials, sponsored by clinical oncology groups, in combination treatment scenarios for solid tumors.

OSE-279 (anti-programmed cell death protein 1 [PD-1]).

 This candidate has generated its first set of positive results in an ongoing Phase I/II study in solid tumors. OSE-279 is the primary therapy derived from the company’s bispecific fusion protein platform, BiCKI.

OSE-127 - lusvertikimab (humanized mAb antagonist of interleukin 7 [IL-7] receptor).

 This candidate is in an ongoing Phase II study in ulcerative colitis and in ongoing preclinical research in leukemia.

 This mAb was developed in partnership with Veloxis Pharmaceuticals, an Asahi Kasei company, for use in transplantation treatment. It is in ongoing Phase I/II studies in renal transplant and an ongoing Phase I study in the United States.

BI 765063 and BI 770371 (anti-signal-regulating protein alpha [SIRPα] mAb on CD47/SIRPα pathway).

 These candidates were developed in partnership with Boehringer Ingelheim for treatment of advanced solid tumors. They have demonstrated positive Phase I dose-escalation results in monotherapy and in combination, particularly with the anti-PD-1 antibody, ezabenlimab. They are also in an ongoing international Phase Ib clinical trial in combination with ezabenlimab alone or with other drugs for treating patients with recurrent/metastatic head and neck squamous cell carcinoma and hepatocellular carcinoma.

In addition to these pipeline candidates, OSE Immunotherapeutics also expects to generate further potential candidates based on its three proprietary drug discovery platforms:

Pro-resolutive mAb platform, which focuses on targeting and advancing the resolution of inflammatory conditions and optimizing the therapeutic potential of targeting neutrophils and macrophages in immunology and inflammation (I&I). OSE-230 is the first candidate generated by this platform. Additional discovery programs are ongoing on new pro-resolutive G protein-coupled receptors.

Myeloid Checkpoint platform, which aims to optimize the therapeutic potential of myeloid cells in immuno-oncology (IO) by targeting immune regulatory receptors that are expressed by macrophages and dendritic cells. BI 765063 and BI 770371 are the most advanced candidates generated by this platform. There are also additional ongoing discovery programs, with positive preclinical results obtained in monotherapy studies with new anti-C-type lectin-like receptor-1 mAbs.

Cytokine platform, which focuses on leveraging the Cis-delivery of cytokine in IO and I&I. BiCKI is a bispecific fusion protein platform. It is built on the key backbone component of anti-PD-1 combined with a new immunotherapy target. This combination aims to increase anti-tumor efficacy. BiCKI-IL-7v is the most advanced candidate generate by the BiCKI platform, which targets anti-PD-1xIL-7. There are ongoing additional discovery programs on Cis-demasking technologies.

Articles

Under a global license and collaboration agreement, AbbVie and OSE Immunotherapeutics will aim to develop OSE-230, a mAb for treating chronic inflammation.

AbbVie Partners with OSE Immunotherapeutics on Novel mAb for Chronic Inflammation

CordenPharma announced on March 6, 2024 that it is expanding capacity at its Frankfurt, Germany site to accommodate the manufacture of early clinical-phase peptide APIs for its pharmaceutical and biotech customers. The company is planning for the expansion to be operational in the second quarter of 2024 with authorization by German authorities completed in the second half of 2024.

As part of the expansion, 1000 square meters of manufacturing space will be added to the Frankfurt site. The site will add two fully equipped lines comprised of a solid phase peptide synthesizer, high-pressure liquid chromatography, liquid phase isolation equipment, and quality control laboratories. The quality control labs will feature in-process control, starting material batch release, and good manufacturing practice (GMP) stabilities. The GMP manufacturing area will produce peptide APIs from gram to kilogram range for clinical Phase I and Phase II requirements with later transfer to the company’s late-phase and commercial manufacturing Boulder, Colo., site in the United States.

The GMP expansion will support the launch of the integrated services between the company’s CordenPharma Frankfurt site and CordenPharma Caponago, which offers services for injectable drug products. The integrated peptide-injectable services will be tailored to the individual customer and will deliver technical, manufacturing, and regulatory support for investigational new drug (IND)/investigational medicinal product dossier (IMPD) filings and first-in-human (FIH) clinical trials. Customers will benefit from working with one contract development manufacturing organization with a single contract, quality agreement, and project management. The offering also features API route selection, salt and solubility studies, API characterization, and reference standard qualification. Formulation development, analytical method development, and validation will also be provided. Assistance with technical writing for IND/IMPD submissions will also be available.

"With our new early clinical GMP peptide manufacturing investment in Frankfurt and the launch of seamlessly integrated peptide API to injectable drug product services, CordenPharma is uniquely positioned to deliver customized CMC [chemistry, manufacturing, and controls] support for biotech customers and facilitate their successful IND/IMPD submissions and start of FIH clinical trials. We believe the offer will bring added-value and increased efficiency to our customers, and ultimately enhance the well-being of their patients,” said Stéphane Varray, CordenPharma’s Global Peptide Platform director, in a press release.

previously expanded the Frankfurt site in 2020

 to include an increase in available lab space by 25% and the addition of a dedicated explosion proof area.

the company invested €9.7 million (US$10.9 million) i

nto the design and installment of a new clinical trial development facility for manufacturing oral solid dosage drug products at its Plankstadt facility near Heidelberg, Germany.

 the company also launched its new Lipid NanoParticle (LNP) Starter Kits 

for the formulation of messenger RNA (mRNA)-based therapeutics, such as mRNA vaccines or gene therapies. The starter kits are designed to provide researchers and developers with the essential components needed to create and optimize their own LNPs for mRNA delivery. The kits allow users to fine-tune the LNP formulation process and achieve production of nanoparticles with the desired physicochemical characteristics, such as polydispersity index ≤0.2 and a size range between 30–150 nm, depending on specific LNP reaction conditions, lipid composition, and cargo used.

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.

CordenPharma Expands Clinical Peptide Capacity

How Adare Pharma Solutions is evolving to keep pace with changes in the industry.

Adare Pharma Solutions - Evolving to Meet the Future Needs of Customers

Oral solid dose capabilities and small molecule expertise

Recent and planned expansions in packaging, high potency, and controlled substances offerings as well as a new nitrosamine mitigation offering

Wide-scale resources have increasingly been deployed to find, characterize, validate, bank, and file patents for cancer neoantigens. It has been a biological landgrab echoing the single nucleotide polymorphism (SNP) fervor at the turn of the century. In a conversation late in 2023 with Maravai’s chief innovation officer Kate Broderick and Accuitas’ CEO Tom Madden on future applications for messenger RNA (mRNA)-based therapeutics, the notion came up as a potential lynch pin. Broderick commented that, “there was a beautiful study that came out of a large group in the UK [United Kingdom] called the TRACERx Study where they actually monitored people's cancers over time and fairly frequently, and within a matter of a month, some of these tumors had completely changed their neoantigen profile. So, to [Madden]'s point, the need to have really unprecedented speed to make this, the promise of personalized vaccines prominent … is absolutely key now” (1). However, lacking in mature and effective tools and equipment, activities have been labor intensive and, for the most part, produced only halting successes.

. from the La Jolla Institute for Immunology with a new platform approach described in a February American Association for the Advancement of Sciences (AAAS) paper (2). This new approach appears to work well on cancers pictured as evading patients’ immune systems, in part because these cancers do not carry many mutations. However, while these cancers are not infiltrated by cancer-fighting immune cells, the tumors do appear to trigger some cancer-fighting T cells and can perhaps be entrapped, thus “heating up” cold cancers.

The first principles that follow might seem complex, but some amount of future therapeutic target tractability may well require basic understanding of those principles. From the paper’s introduction “the genetic instability underlying neoplastic transformation can also provide tumor-specific targets for host T cells. These include function-altering mutations in so-called ‘driver’ genes, which endow the tumor with growth and survival advantages, as well as tumor-specific variants of ‘passenger’ genes that lack an obvious protumorigenic function” (2).So far so good; cancers behave and interact differently from regular tissue in ways that leave characteristic biological trails that can be tracked. Along this trail researchers recognize mutated peptides bound to the surface of human leukocyte antigen (HLA) molecules for recognition as neoantigens by patients’ CD8 and CD4+ T lymphocytes. Researchers have been aware of neoantigens for some time and have wanted to target these tumor specific targets; however, it has been a substantial challenge to do so.

A typical traditional neoantigen discovery setup relies on next-generation sequencing (NGS), complex algorithms/databases, and a certain distrust regarding the utility of the eventually upturned somatic nonsynonymous mutations (NSMs). The process is expensive and slow. A second method assesses T cells in peripheral blood or tumor-infiltrating lymphocytes (TILs). This can be “technically challenging or require specialized cellular reagents, such as autologous dendritic cells, thus limiting their utility in routine neoantigen screening using nominal clinical samples” (1). The La Jolla team set out instead to forge an “unbiased and HLA-independent strategy for the functional validation of spontaneous neoantigen-specific CD4+ and CD8+ T cell responses that uses NGS-guided selection to nominate NSMs for functional recognition testing in a short-term culture of autologous peripheral blood mononuclear cells (PBMCs), which reports on both T helper cell 1 (TH1) and TH2 cytokines. Using this approach (herein referred to as ‘IPV’ for identify-prioritize-

validate), we now show that preexisting CD4+ and CD8+ T cell responses can be identified and the T cell receptors (TCRs) that mediate them can be isolated at rates that are about 10-fold higher than class I HLA binding–based predictive approaches across a spectrum of tumor types and degrees of tumor mutational burden using routinely available clinical samples” (2). It will likely have been understood that by integrating elements of both traditional approaches, this new platform performs in a more HLA-agnostic and clinic-capable manner and is, henceforth, a healthy step ahead in terms of reliably churning out tumor target information—especially regarding low mutation tumor profiles. It is also a step toward a better understanding of tumor microenvironment interactions with an individual’s immune system, which alone makes it an effort worth celebrating.

There are some drawbacks and limitations, however, and these can be found in the discussion section of the AAAS paper. But the expectation to “routinely and reliably identify natural tumor-specific neoantigens and the TCRs that recognize them” will indeed “be crucial to the development of precisely and accurately targeted immunotherapies that can effectively offer therapeutic benefit while avoiding off-tumor toxicities” (2), which is a long-sought goal in oncology research now visibly present as a functional platform technology.

, Oct. 17, 2023.
2. Miller, A.; Schoenberger, S.; Peters, B.; Cohen, E. A functional identification platform reveals frequent, spontaneous neoantigen-specific T cell responses in patients with cancer. 

 (736), eabj9905. DOI:10.1126/scitranslmed.abj9905

Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Research into Cold Cancers Heating Up

 in 2014, Adam Goulder has over 30 years' experience within the maintenance engineering and asset management sectors including Pharmaceutical and Medical Devices manufacturing. As Head of Project Management and a Principal Consultant Adam oversees the management and implementation of enterprise asset management solutions to a wide range of organisations across the Pharmaceutical, Medical Devices, Healthcare, Logistics, Facilities Management, Utilities, Oil & Gas, and Transportation sectors. Adam is a Chartered Engineer, holds an MSc in Maintenance Engineering and Asset Management from the University of Manchester and is a member of the International Society of Pharmaceutical Engineers.

Cloud technology. Integrated digital web concept background | Image Credit: © kras99 - Stock.Adobe.com

According to the Cloud Industry Forum’s (CIF) 2023 annual report, 95% of businesses across the public, IT and technology, financial services, retail, and manufacturing sectors are now operating within the cloud, in one form or another (1). This figure highlights the rapid growth of the technology, which saw the global market value reach more than $569 billion in 2022 and is estimated to exceed $677 billion (2) in 2023 expanding at a compound annual growth rate o

Further findings from the survey also revealed that 55% of those polled are now operating a hybrid (cloud and on premise) approach, while “42% are embracing a cloud first strategy” with “96% saying their cloud strategy has delivered against expectations” (1).

Growth of the technology in the pharmaceutical industry is slower, however. Globally, uptake in the sector was valued at $4.8 billion in 2022, and reports suggest that growth will be around over 13% in 2023(3). While this growth does show acceptance of the technology by those working in the industry, it highlights that the sector is behind in its adoption compared to other major industries.Those companies in the sector that have transitioned to a cloud-based environment though have been reaping the benefits, which includes enhanced data analytics, reduced time required for innovation, and establishing standardized processes across sites.

While the benefits are well reported, these findings do raise the question, ‘Why are pharmaceutical companies reluctant to adopt cloud technologies?’

Several reasons are commonly given for why pharmaceutical companies don’t adopt the cloud. These reasons include regulatory compliance, data security, data privacy, costs, risk aversion, and data sovereignty.

The reality is that while there is a framework already in place to guide pharmaceutical companies around the implementation and use of cloud technologies, for example the International Society for Pharmaceutical Engineering’s (ISPE’s) Good Automated Manufacturing Practice (GAMP) guides, the industry’s hesitance to invest into new systems and its “late adopter” approach when onboarding new technology is slowing the sector’s widespread adoption of this hugely beneficial technology.

Data security as well as data privacy laws like the European Union’s (EU’s) General Data Protection Regulation (GDPR) or the US Health Insurance Portability and Accountability Act (HIPAA) demand that cloud providers are compliant with these laws. Requirements include consideration and controls related to geopolitical jurisdiction of data, and where they reside can provide compelling reasons for some multinational pharmaceutical companies to adopt the cloud and avoid the difficult decisions right now.

Though dependent on the benefits and risks of the overall program of work, cost will always play a part of a final decision to some greater or lesser degree. Pharmaceutical companies must ultimately ensure their products and services are compliant with regulations such as 

 (6), as well as others, and thus going with a legacy technology platform that is understood but less efficient or less flexible in the short term, may be perceived as less risky than adopting new technologies such as the cloud. The typical approach taken by many pharmaceutical companies has been to adopt the cloud where patient safety is not directly impacted and the systems that are deployed on them are of a lower risk (such as marketing, training), and only after a period of stable use, will a wider adoption to host production and patient safety critical systems occur.

With the qualification criteria of any patient safety system so stringent, delays to resolve issues or acceptance of defects often allowed in other industries are generally not permitted in the pharmaceutical sector. This added burden of resilience and efficacy often sways organizations from making the decision and postponing until confidence or circumstance force their hand.

Reasons behind the industry’s reluctance to widespread adoption of the cloud

The pharmaceutical industry’s hesitance to fully embrace cloud technologies, and digital transformation, can be boiled down to three concerns: regulatory, solution efficacy, and the underlying cost of validation.

It is not an understatement to say that adopting new systems can be a large undertaking, and just like any other organization, the switch can come at a significant cost, both in terms of the outright purchase, license, and support, but also the cost of integrating these into the existing business. These costs for example may include extended training, new hires, and their related onboarding, in addition to upgrading of existing infrastructure to allow the new systems to be able to work with each other. Furthermore, the industry’s need to manage risk and ensure their systems are verified and validated also demands significant time and a sizeable investment, adding to the challenge of the rapid adoption of digital technologies. Numbers can vary dramatically, but in the author’s experience between 25% and 40% of the overall software implementation budget for a cloud hosted solution is spent on the qualification and validation of the solution. This significant proportion of the overall project cost can at least delay the investment decision and at worst halt them altogether.

There is also the perceived risk with adopting new, “fresh out of the box” systems, and the associated effort in identifying the necessary tests and operational controls to ensure confidence and compliance of the system. These controls must ultimately ensure that any doubt in the systems efficacy is covered by reliable processes, procedures, and systems to mitigate the potential for failure.

As a result of this expansive effort and suitable controls, the pharmaceutical industry generally falls into the “late majority” technology adopter category by not utilizing new technology until it has proven its worth over time and thus has shown demonstrable reliability and extensive uptake in the market before doing so. This approach often results in staying locked in a technology path which “works” but which runs the risk in the long term of becoming out of date and a liability for future migration into the cloud.

Globally, cases exist of pharmaceutical companies operating on legacy and thus no longer supported infrastructure and systems—hoping that they continue to work until the decision to replace or upgrade is taken. As regulation advances, however, the assessment and subsequent decision to remain on these legacy platforms will become less likely until such time that a decision to move must be taken at all costs.

However, here are successful examples (7) of pharmaceutical companies utilizing cloud hosted systems in the development of drugs. In 2021 for example, UCB partnered with Microsoft, using its cloud and artificial intelligence (AI) solutions to improve the development of drugs in immunology and neurology. During the same year, Pfizer partnered with AWS to utilize machine learning and cloud capabilities to streamline its drug discovery and development efforts. It is therefore possible that the switch to cloud-based solutions can lead to significant benefits.

Other recent challenges facing the pharmaceutical industry

Like many sectors over the past few years, but more so for the pharmaceutical industry, the impact of COVID-19 has challenged the way in which business operates and tested processes and systems sometimes beyond their designed capabilities. This momentous challenge forced change and set deadlines beyond what was thought possible to an industry that measured success in delivery of drugs and vaccines in years not months that ultimately meant companies had to adapt far more quickly than what they would have historically done—with the cloud playing its part in enabling this rapid transformation.

Cloud-based systems allow organizations to securely capture and share clinical data far more rapidly. The unprecedented global health crisis prompted several changes within the industry that supported the acceleration of cloud-based operations and resulted in the delivery of vaccines around the world in record time. These included cloud-based remote R&D laboratories and supported secure collaborations and sharing of data between different research teams to streamline and accelerate the development phase of the program.

The cloud enables pharmaceutical companies to face such challenges as described above, head on, by supporting their regulatory compliance needs through the delivery of a secure and reliable platform that underpins and supports their validated systems. Reliable cloud-based systems provide scalable real-time monitoring, data analytics, and predictive maintenance that detects performance changes alerting support staff of potential problems before they become issues to end users.

Furthermore, auditing and security features inbuilt within cloud platforms ensure data are safe and secure, giving pharmaceutical companies the reassurance that their data are compliant and that the systems are capable of scaling and adapting to cope with the pharmaceutical businesses future needs. The next COVID event may be just around the corner, and business continuity plans and risk mitigation strategies should factor in those tools that provide support for scaling up to meet demand and secure collaboration when required.

Cloud computing allows for scalable and cost-effective storage resources that can also support a common platform streamlined validation approach. However, choosing the right partner to implement those systems, one who has the right level of expertise and experience is considered essential to save on the cost and onboarding and mitigate concerns when implementing a new cloud based digital system.

The right partner can support user and system requirements definition, testing, and qualification and validation activities, thereby reducing the operational impact on the pharmaceutical company. Following implementation, this transfer of responsibilities to the cloud platform provider reduces business overhead and time necessary to manage these complex systems. With less physical infrastructure, the responsibility for the pharmaceutical company should reduce, with the pharmaceutical company more able to focus efforts on the management of change and transition to cloud focused operations, thereby maximizing the benefits of security, accessibility, and integrity of data with an overall reduction in operational overhead.

While the benefits of widespread cloud adoption are clear in terms of efficiency, scalability, and collaboration and rewards achievable, the sector’s hesitant approach is clearly rooted in valid concerns around data security, regulatory compliance, cost, and the ability to partner with a knowledgeable and reputable service provider to successfully make the change happen.

However, the industry and pharmaceutical landscape is evolving, and several industry leaders have already recognized the potential that the cloud can have on the sector. It is anticipated that interest in cloud adoption within the industry will continue to grow in the coming years, which will pave the way for an industry that is secure, compliant, and has the ability to scale and adapt at pace to meet the challenges that will be presented in the future.

Cloud Industry Forum: Breaking New Ground with Cloud. 

Research Report (April 2023).
2. Fortune Business Insight. 

Cloud Computing Market Size, Share, and COVID-19 Impact Analysis, by Type, by Service, by Industry, and Regional Forecast, 2023–2030

. Market Report, May 2023.
3. Industry Research. 

Cloud Computing In Pharmaceutical Market in Pharmaceutical Industry Research Report 2023, Competitive Landscape, Market Size, Regional Status, and Prospect

Market Report, September 2023.
4. European Commission. 

Good Manufacturing Practice and Good Distribution Practice

. Guidance Document, Dec. 18, 2014 (updated Dec. 27, 2020).
6.

Electronic Records; Electronic Signatures

. March 20, 1997.
7. GlobalData. The Impact of Cloud Computing on the Pharmaceutical Industry. 

When referring to this article, please cite it as Goulder, A. Why Are Pharmaceutical Companies Reluctant to Adopt Cloud Technologies? 

Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.

Why Are Pharmaceutical Companies Reluctant to Adopt Cloud Technologies?

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Retro classic typewriter from circa 1950s with sheet of paper and aged books on wooden desk front aquamarine wall background. Nostalgic writer's work place concept. Vintage old style filtered photo | ©BrAt82 - stock.adobe.com

Between 10 and 17 May 2025, European eyes, and indeed eyes from all over the world, will be set on Basel, Switzerland for the 69th Eurovision Song Contest, where creativity and talent are celebrated in a multi-show spectacular! The first ever Eurovision Song Contest was held in 1956 in Lugano, Switzerland, and while there were only seven nations competing against each other for the inaugural competition, the Swiss came out on top and won (1).

The contest’s return to the country it was founded in, Switzerland, was too good an opportunity for Swiss pharma giant, Novartis, to miss. While it may seem an unusual pairing—Big Pharma with a music competition—the company is seeking to use this global platform to promote its broader campaign of “reimagining medicine, together” (2).

“Novartis is honoured to be an official partner of the 2025 Eurovision Song Contest in Basel—our home city. Both our organizations were born in Switzerland and believe deeply in the power of collaboration and bringing people together,” said Rob Kowalski, chief people & organization officer for Novartis, in a press release (3).

Indeed, the power of collaboration is a critically important for the bio/pharma industry—a detail that was proven during COVID-19 when collaborative efforts helped push therapeutic advances forward to the benefit of patients around the world. On a personal note, when reflecting on the fact that this is my last issue of 

, I must agree that working closely with many industry experts has been key to ensuring success throughout my various editorial roles over the years. And, as I prepare to depart my wonderful Pharmaceutical Technology Group colleagues for my next professional adventure, it will be the relationships and collaborations that I will celebrate most!

So, eagerly awaiting this year’s Eurovision Song Contest extravaganza, I wish Switzerland’s entry, Zoë Më, ‘bon chance’ for their song ‘Voyage’ as I set off to embark on my own new voyage with new collaborations.

Eurovision Song Contest. The Origins of Eurovision. 

Novartis. The 2025 Eurovision Song Contest. 

Eurovision Song Contest. Novartis Announced as ‘Official Partner’ for Basel 2025. Press Release, 31 Oct. 2024.

Felicity Thomas is Associate Editorial Director of PharmTech Group.

When referring to this article, please cite it as Thomas, F. A New “Voyage”. 

The power of collaboration is a critically important for the bio/pharma industry.

A New “Voyage”

Medical background. many capsule tablets or pills on blue table. Glass vials. Vaccine. Close up. Healthcare pharmacy and medicine concept with copy space Painkillers or prescription drugs consumption | Image Credit: ©taniasv - stock.adobe.com

The landscape of treatment for medical conditions and illnesses has become tailored and rich thanks to advances in personalized medicine, artificial intelligence (AI), and emerging modalities. Cell and gene therapies have been joined by messenger RNA (mRNA) vaccines in pushing innovation in the field of drug dosage forms. New manufacturing trends have also spurred the drive for new ways to deliver life-saving medicines.

“A confluence of innovative technologies is reshaping the healthcare market. Among these cutting-edge approaches, [AI], data analysis and management, blockchain technology, real-world data utilization, cybersecurity, and continuous manufacturing processes stand out as driving this paradigm shift,” says Jnanadeva Bhat, vice president at ACG Capsules (R&D). “These technological catalysts are not only bolstering medication delivery but also propelling forward the entire spectrum of development, packaging, and final product distribution to end consumers. Pharmaceutical industries are making up these newer technologies for innovation in healthcare.”

Tailoring dosage forms to individual patient needs is becoming a reality, confirms Ramesh Subramanian, chief commercial officer at Aragen Life Sciences. Treatment efficacy can be improved by customizing formulations based on genetic profiles and patient-specific requirements, which may minimize side effects, he emphasizes.

A shift in patient attitudes is also influencing innovation in dosage forms, according to Arnaud Verhaeghe, marketing director Pharma Oral Dosage at Roquette. “Compared with 10, or even five years ago, consumers are far more discerning about the types of drugs or individual ingredients they allow into their bodies,” says Verhaeghe. “This [change] is reflected in the demand for improved digestibility and convenience, personalized treatments in fields such as oncology, endocrinology, and infectious diseases, and especially in the recent ‘vegan revolution.’ The latter, in particular, has had implications for established drug formats like softgels. [Because] the traditional excipient of choice—animal-derived gelatin—is unsuitable for vegan or vegetarian applications, brands have turned to cutting-edge technologies, like first-of-its-kind hydroxypropyl pea starch…Such excipients are unlocking the potential to create high performance, planet-friendly plant-based drugs that are easy for consumers to swallow—both literally and metaphorically.”

Patient adherence is also making an impact on the development of dosage forms. “For decades, patient groups, including children, the elderly, and people who experience issues swallowing, have had no choice but to use medications that are inconvenient, difficult, or even dangerous to take. At best, this can lead to pill fatigue, and at worst complete non-adherence,” says Verhaeghe.

Permeability is also causing an impact on dosage form choice, according to Lisa Caralli, senior director, Scientific Advisory at Catalent. “Addressing permeability limitations for peptides and biomolecules has been an area of intense focus in recent years, with the modulation of tight junctions with excipients remaining a key approach,” she says. “First pass metabolic loss for small molecules will also drive the use of the injectable route, whereas pregastric delivery through the mouth with dosage forms such as orally disintegrating tablets remains an under-explored area to address this metabolic concern.”

Ishani Maharaj, application development specialist, pharma ingredients at Univar Solutions, also points to issues with API solubility and permeability as pushing the demand for improved formulation strategies. The use of solubility and permeation enhancing excipients allows for APIs with improved bioavailability and increased efficacy, she explains.

“To formulate these APIs as solid dosage forms, there have been promising strategies such as amorphous solid dispersions (ASDs), co-processed APIs, and lipid-based formulations (LBF),” continues Maharaj. “With the use of a lipid base delivery system consisting of a solvent, surfactant, and co-surfactant, a self-emulsifying delivery system can be formed in the digestive tract. This
[delivery system] allows improved dissolution of the drug within micelles and for better systemic absorption of the water-insoluble API. Choosing the right components of a lipid-based delivery system for a particular API can be complex. To address this, excipient manufacturers are now delivering ready-made lipid-based pre-concentrates to simplify this process for formulators.”

New technologies are also making an impact on dosage form development. Manali Dalvi, lead–White Papers & Publications at ACG, points to the integration of three-dimensional (3D) printing as one of the innovations creating new capsules that can be tailored to individual patients. “This breakthrough empowers manufacturers to effectively address the unique therapeutic needs of each patient,” says Dalvi. “Moreover, capsules also offer fresh perspectives on fixed dose combinations, introducing flexibility in the composition of capsule inner content. This versatility opens the door to a wide range of potential constituents—ranging from powders and pellets to semisolids and various liquid forms (solutions, suspensions, emulsions)—to be encapsulated within,” she notes. “As the field continues to advance, it has become imperative for pharmaceutical manufacturers to stand at the forefront of this transformative shift, driving innovation and personalized care forward.”

Developments in advanced and complex therapies have seen a surge in recent years. Bhat points to advances in genetics, molecular biology, and biotechnology as the drivers of these new treatments.

“Many researchers are eager to capitalize on these scientific breakthroughs,” asserts Bhat. “Complex therapies such as gene and cell therapies have the potential to offer advance treatment for the diseases that have been challenging to address with conventional medication. For example: cancer, heart disease, and cystic fibrosis. Many pharmaceutical companies have successfully developed and commercialized complex therapies, gaining the competitive edge in the sector, positioning themselves as leaders in medical innovation.”

Complex and advanced therapies often come with manufacturing and patient adherence challenges. How can industry meet these challenges?

The challenge of bioavailability is often seen in newly developed APIs, which exhibit poor solubility and where adequate dosing in a convenient dosage form is difficult, according to Verhaeghe. “This presents significant challenges, both in terms of manufacturing and end-user compliance,” he says. “But drug developers are fighting back with some truly ingenious approaches. One of the most exciting examples has been the expanded interest in specialized and co-processed excipients as processing aids and final-formulation ingredients. Cyclodextrins, for instance, have delivered great results in this area—their molecular encapsulation properties and affinity with complex molecules helps simplify formulations, increase solubility, and assure stability.”

Nick DiFranco, MEM, Global Market Manager, Novel Pharmaceutical Technologies at Lubrizol, agrees. “Complex therapeutics often involve challenges such as poor solubility or a high dose of drug. These challenges require efficient excipient technologies to solubilize compounds, control drug delivery without resulting in a tablet that’s too big to swallow, or avoid injections with extensive infusion times,” he says. “For example, if an oral tablet formulation is not optimized, patients may need to take tablets three or four times a day to achieve a desired therapeutic effect. Using excipients that enable high drug loading and/or control over release can increase the amount of drug per tablet while minimizing side effects, which reduces pill burden and offers huge benefits to patients. These excipient technologies don’t necessitate complex manufacturing techniques either.”

A multi-faceted approach can be used to address these challenges, according to Subramanian. “These innovations not only improve patient outcomes but also facilitate the development and commercialization of these advanced therapies,” he says. “Complex therapeutics often require specialized delivery systems, such as liposomes, nanoparticles, or microspheres that can improve drug stability, bioavailability, target specific tissues, and control release rates, enhancing the therapeutic effect.”

By way of example, Subramanian highlights nano-based formulations, 3D printing, and novel excipients as useful tools. “Nano-based formulations can enhance the therapeutic efficacy of complex drugs and reduce side effects,” he remarks. “3D printing is another technology that can help meet the dosage form requirements of complex therapies and bring formulation manufacturing closer to patients. [The technology] allows for precise control over the structure and composition of dosage forms and enables the creation of customized and patient-specific dosage forms, which is particularly valuable for complex therapies. The development of novel excipients can enhance the stability of complex therapeutics and improve their manufacturability. These excipients may be used to protect sensitive compounds or modify drug release profiles.”

Additionally, Subramanian points to quality by design as a tool in the development of complex dosage forms that uses a systematic approach to formulation to meet quality and performance requirements.

Filipe Gaspar, VP of Technology Intensification at Hovione, points to the company’s search for new technologies to deliver new modalities instead of technologies that come with limitations in formulation options, such as freeze drying. “Precise control over particle size and density, coupled with formulation design, is an enabler for high dose and low volume injections maximizing patient compliance,” he says. “At a much more mature phase is the use of respiratory delivery (inhalation and nasal) for biopharmaceuticals using spray drying technology which offers ample formulation options. Developing a highly efficient delivery device and product combination which ensures that an unskilled patient receives the intended effect is as important to address.”

The growth of the biologics market and patient-centric dosage forms have promoted the development of parenteral formulations and long-acting injectable products, according to Maharaj. “Injectable dosage forms are adequate when assessing the balance between benefit and inconvenience. The pursuit of convenient and reliable devices that can simplify injection procedures and give autonomy to patients can be a promising strategy to deliver such complex medicines in a patient-friendly way. Wearable devices such as a microneedle autoinjector could be a good candidate for delivering these larger molecules such as proteins, peptides, and monoclonal antibodies,” she says.

Delivering high-value biologics orally, however, will be a priority for the industry, continues Maharaj, because it is non-invasive. Delivery methods for biologics that are not readily absorbed after oral administration, however, will also be explored, she remarks.

“For example, monoclonal antibodies (mAbs) have a variety of potential therapeutic applications in autoimmune diseases and cancers. The dosage form remains a major obstacle for mAbs as frequent intravenous administration can reduce patient adherence,” says Maharaj. “Subcutaneous administration promises improved patient convenience and compliance due to the possibility of self-administration by patients, less visits to the hospital, and low healthcare costs.”

A push from regulators to develop advanced therapies also gives incentive for sponsor companies to invest in technologies and processes for complex therapies. FDA’s Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME) allows for agency review of novel excipients, which “will foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients” (1).

“Novel excipients can be the key to producing products with improved bioavailability and reduced side effects,” says Caralli. “For example, surfactant excipients are often used to solubilize molecules with low aqueous solubility, or to form emulsions. However, some of these excipients are known to cause a hypersensitivity reaction in some patients, therefore, by using alternative forms that do not induce this reaction could provide a better and safer patient experience. Another area is innovation in polymers used for amorphous systems: highly crystalline drug substances can be transformed into their amorphous state, and stabilized with polymers to improve in-vivo solubility, and therefore, bioavailability. Novel polymer systems that can be used at lower processing temperatures in hot melt extrusion may reduce drug degradation and improve processability.”

Technologies being adopted in laboratory hardware and data analytics are accelerating the development of dosage forms, according to Gaspar. “[Laboratory hardware] enables fast optimization, and [data analytics] transform the continuous accumulation of data (experience) into knowledge that can be multiplied for every new drug under development,” he says.

Gaspar points to continuous manufacturing of oral dosage forms as an example of a way to utilize data analytics because of the rich data environment and sophisticated process equipment and process analytical technology. “Scientists and engineers can interact with such a broad data environment and build sophisticated models that are normally used in control strategy definition, while also monitoring the manufacturing process not just with a few selected process parameters, but potentially with the full process data that can be analyzed by multi-variate methods to inform potential faults in real-time,” he notes. “During drug product development, it facilitates execution of extremely fast [design of experiments] and exploration of a design space.”

Caralli believes AI will play a pivotal role in drug dosage design. “[AI’s] ability to quickly synthesize current research will dramatically increase the speed of bringing new ideas into reality. [AI] could assess current dose design trends, based on patient populations and indication, allowing the optimization of drug administration, and ultimately increasing the rate at which drugs advance into the clinic,” she says.

However, Caralli cautions that AI-generated information may not be completely reliable. “Firstly, it may be detrimental to true innovation as it becomes easier to build on the ideas of others rather than generate new ones; and additionally, there is a need to override the natural impulse to publish studies showing what has been successful, versus what has not to avoid generating a biased data set. The industry may find itself becoming too trusting in the seemingly confident answers generated by AI, that it may not apply human skepticism, which is an important part of the scientific method,” she summarizes. “However, as the ability to identify trends through AI improves, the safety benefits to patients may ultimately outweigh the risks to innovation.”

1. FDA. Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME). 

®
Vol. 48, No. 3
March 2023
Pages: 12-14

When referring to this article, please cite it as Haigney, S. Reshaping Dosage Forms. 

Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Reshaping Dosage Forms

Gayatri C.Patel, M.Pharm, PhD, is associate professor in the Department of Pharmaceutics & Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy at the Charotar University of Science and Technology, Changa Campus, Changa- 388 421, Anand, Gujarat, India, gayatripatel.ph@charusat.ac.in, +91 2697 265162.

Divyangi Patel is a research scholar at Charotar University of Science and Technology, Ramanbhai Patel College of Pharmacy, Department of Pharmaceutics & Pharmaceutical Technology, CHARUSAT Campus, Changa-388421, Gujarat, India.

Submitted: June 8, 2023.
Accepted: January 5, 2024.

Cefpodoxime proxetil (CFPD PRXL) is a third-generation cephalosporin antibiotic with broad-spectrum activity. However, its bitter taste often leads to poor patient compliance. This study aimed to develop a taste-masked drug resin complex (DRC) using the ion exchange resin Kyron T-114. Various variables, including resin ratio, pH, temperature, soaking time, and stirring time, were investigated for their impact on drug loading and taste reduction. A dispersible tablet was then formulated using the DRC and other pharmaceutical excipients. The formulated tablet underwent evaluation for weight variation, hardness, dimension uniformity, friability, content uniformity, wetting time, 

 drug release. Results demonstrated that the wetting and disintegration times of the tablets, as well as the 

 drug release, were comparable to those of the commercially available CFPD PRXL product. In conclusion, the developed method for taste masking CFPD PRXL and preparing orodispersible tablets proved to be simple, cost-effective, and potentially suitable for industrial application.

Cefpodoxime proxetil (CFPD PRXL) is a third-generation cephalosporin antibiotic with broad-spectrum activity commonly prescribed in both solid and liquid forms to treat various bacterial infections, including upper respiratory infections, ear infections, skin infections, and urinary tract infections (1–3). However, its extremely bitter taste poses a challenge for patient compliance, particularly among pediatric and geriatric populations. Solid dosage forms such as tablets are frequently used for these patients (1–3).

Ion exchange resins are solid, high-molecular weight polyelectrolytes that can reversibly and stoichiometrically exchange their mobile ions with the surrounding medium. These resins are available in various sizes and can be utilized to adsorb bitter cationic drugs onto weak cation exchange resins containing carboxylic acid. This interaction forms a complex that effectively masks the bitterness of active ingredients (4). Resinates can then be formulated into lozenges, chewing gum, suspensions, or dispersible tablets, effectively concealing the taste (3).

The binding of drugs to the resin can be achieved through repeated exposure or prolonged contact with the resin. By forming weak ionic bonds between the drugs and the oppositely charged resin substrates or resinates, the drug-resin complex (DRC) remains stable under salivary pH conditions, successfully masking the unpleasant taste and odor of the drugs.

The objective of this study was to incorporate the DRC into a dispersible tablet to enhance patient compliance (5–6). In a previous study, the preparation and evaluation of the DRC was performed using Kyron T-114, a weak acid derivative of methyl acrylic acid cross-linked polymer having a carboxylic acid functional group, which is responsible for its taste masking property for a pharmaceutical suspension; however, its use in tablet formulation was not investigated. Therefore, the specific objective of this present study was to develop and evaluate an orally disintegrating tablet (ODT) of CFPD PRXL using the optimized DRC that were utilized for suspension formulation (6).

 is a research scholar, both at Charotar University of Science and Technology, Ramanbhai Patel College of Pharmacy, Department of Pharmaceutics & Pharmaceutical Technology, CHARUSAT Campus, Changa-388421, Gujarat, India.


*To whom all correspondence should be addressed.


Vol. 48, No. 3
March 2024
Pages: 22–26

When referring to this article, please cite it as Patel, G.; Patel, D. Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil. 

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

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