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

Rees Scientific 

to discuss Rees Scientific's evolution in the market. Learn more about: 

How real-time monitoring of critical environment conditions allows Rees to ensure customers that their products are stored and handled under optimal conditions.

The ease of integration for their monitoring systems into any existing infrastructure.

The importance of temperature mapping and how that helps to protect the efficacy of a product.

Videos

Josh Hirshenhorn (Sales Representative, Rees Scientific) explains current challenges faced by pharmaceutical and biotech companies and how Rees' continuous monitoring systems offer solutions. 

The Impact of Rees Scientific’s Continuous Monitoring Systems in Pharmaceutical and Biotech Companies 

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As CPHI North America, held at the Pennsylvania Convention Centre (May 7-9, 2024) approaches, experts predict that US-based contract development and manufacturing organizations (CDMOs), especially small to mid-sized, should invest throughout 2024 if they wish to maximize on the rise in contract services funding predicted for 2025. Other key trends for 2024 include exploring pilot-scale manufacturing of new technologies, improving supply chain resilience, and ‘friend shoring’.

CPHI expert, Brian Scanlan, operating partner–Life Science Edgewater Capital Partners, sees 2024 as a “holding pattern year”, where funding gradually returns to biotech, as reported in a CPHI press release. He stated that he is already seeing this begin to filter through toward the outsourcing community. But if US-based smaller and medium-sized contract research organizations (CROs) and CDMOs want to benefit from a likely 2025 resurgence, they cannot just wait for the market to return. “They need to be focusing now on operational efficiencies and commercial effectiveness,” Scanlan stated. “This means investing in manufacturing process improvements, like continuous and titer reductions, as well as other areas of the business that could bring overall efficiencies, from enhancing quality management to areas like AI [artificial intelligence] to enhance/accelerate process development and quality trend analysis” (1).

Scalan emphasized that these companies should take every opportunity to invest. “Any area that drives more efficiency in CDMO operations, even streamlining and enhancing effectiveness in new business development using AI enabled tools [is worth pursuing]. So, this will be a year of seeking productivity excellence and cost containment to prepare for a potentially bigger resurgence in outsourcing in 2025,” Scalan said. CPHI North America plans to cover at least one of these potential applications—making use of generative AI to analyze upcoming requirements for pharmaceutical drug manufacturers and distributors as the Drug Supply Chain Security Act comes into effect in November 2024.

“What you are seeing in the USA—and in some ways it’s not a new trend—is a much more considered approach to sourcing,” added Bikash Chatterjee, president and chief science officer at Pharmatech Associates, in the press release (1). “Companies are looking to ensure they have alternative supply and potentially also in different geographic locations from their primary options ... What’s driving this? Well, we have seen a whitepaper come out from HHS [Health and Human Services] earlier this month on preventing drug shortages, and in the next few years we could see companies even scored on their supply chain resilience. So, we might be entering a period when companies are willing to pay more for extra resilience in their networks.”

Chatterjee added that in the next six months many companies will be looking to prepare for 2025, focusing on highly detailed planning for supply chain resilience, as well as a greater short-term focus on ‘near’ or ‘friend shoring’ options (instead of domestic US sites). These countries are currently better prepared, he said, to pick up resources and build ingredients and starting materials networks. More and more North American manufacturers are diversifying their sourcing of ingredients, looking not just to India as an alternative to Chinese suppliers, but also exploring options worldwide, including within Europe and South America.

At CPHI North America, where an anticipated 4000 attendees and 300 companies are planning to attend, these shifting trends will be present. This year’s event is focused on “empowering the North American ecosystem with the new insight and next-generation manufacturing approaches” (1) that it will need to “retool” before the 2025 outsourcing surge. The event will see 58 sessions, with notable keynotes on “Sustainability: Accelerating the Path to Net Zero” and “the Importance of Excipient Grade in Pharmaceutical Drug Development.”

Sarah Griffin, event manager, Pharma Brand US at Informa Markets, emphasized that it is critical for companies to use this event to plan their activity in 2025. "CPHI North America is at the heart of pharma in the US,” she added (1). “It's not just about staying informed and connecting with existing contacts; it's about actively engaging in the collaborative ecosystem that sustains success in the pharmaceutical industry.Participating companies can access invaluable resources, forge vital strategic partnerships, and, most importantly, establish the networks and technologies needed to maximize revenue potential in 2025 and beyond.”

Informa Markets. CPHI North America Experts ‘Mid-Sized Domestic CDMOs Need to Invest in Operational Efficiencies to Drive “Real” Reshoring’. Press Release. informamarkets.com, Apr. 30, 2024.

Articles

Key areas to invest include manufacturing process improvements, quality management, and AI.

CPHI Experts Report that Small to Mid-sized US CDMOs Must Invest Now to Benefit from 2025 Contract Funding Surge

Lonza's Future

to highlight how Lonza is looking ahead. Learn more about: 

How Lonza is optimizing their network to meet the evolving needs of customers while minimizing environmental impact.

The strive to push the boundaries and develop new solutions that address the evolving needs of the industry.

The commitment to providing customers with consistent supply, exceptional quality, and unparalleled service, no matter the challenge.

Meeta B. Kratz (Global Vice President, Product Management & Marketing, Lonza Capsule and Health Ingredients) talks about Lonza's future and how that works in tandem to meet client needs.

Lonza's Commitment to the Future

Feliza Mirasol is the science editor for 

Podcast will explore the technical aspects and advantages of messenger RNA (mRNA) as the basis for therapeutics in cancer treatment as well as vaccines. Based off the success of the mRNA-based COVID-19 vaccines, the biopharma industry is responding with enthusiasm and intense focus on the development of mRNA-based therapeutics for diseases. An area of particular challenge is the delivery of the mRNA therapeutic in vivo. Formulation solutions, such as encapsulating the mRNA within a lipid nanoparticle (LNP) structure, has proven effective. Here, Stefaan De Koker, vice-president of Technology and Innovation, etherna, goes into more detail about the benefits and challenges of developing mRNA-based therapeutics for oncology and vaccines, and discusses the practical application of LNPs toward that goal.

Stefaan De Koker, Vice-President Technology and Innovation, etherna

Stefaan De Koker holds a master in Bioengineering and obtained his PhD at the lab for Molecular Immunology at Ghent University. Throughout his career, he has had a keen interest in understanding how activation of the innate immune system shapes the adaptive immune system and in translating this knowledge into improved vaccines and immunotherapies. De Koker became involved early in the messenger RNA (mRNA) therapeutics field and published seminal papers on the mode-of-action of mRNA vaccines, on the usage of mRNA for intratumoral immunomodulation, and on the development of novel delivery vehicles for mRNA therapeutics. In September 2016, De Kokerjoined ethernawhere he leads the Technology and Innovation team. His focus is currently on the design of customized mRNA lipid-based nanoparticles (cLNPs) for extrahepatic delivery, immunomodulation, and gene editing. De Koker has authored more than 60 publications and is co-inventor on more than 15 patent applications.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

The United Kingdom has launched The Circularity in Primary Pharmaceutical Packaging Accelerator (CiPPPA) initiative to develop and implement strategies for end-of-use recycling of medicinal devices and pharmaceutical packaging. CiPPPA is a collaborative non-profit initiative connecting stakeholders from across the pharmaceutical supply chain. It is managed by a steering committee composed by representatives from within the pharmaceutical and healthcare sector who are committed to creating a future where used packaging from meter dose inhalers (MDIs), blisters, and injectables can be easily recycled.

Currently, the health industry faces a great deal of challenges in regard to recycling primary pharmaceutical packaging (PPP), according to a press release from CiPPPA. Present regulations are strict to uphold the safety, efficacy, and regulatory compliance of each active medicinal product, but they have been unable to consider long-term environmental effects. PPP recycling is also not part of mainstream consumer recycling due to the problematic materials involved, resulting in broader environmental, financial, and regulatory obstacles.

To address these obstacles, CiPPPA has established three action task forces, focused on creating packaging solutions for blisters, inhalers, and injectables. Each task force is led by subject experts who make use of organizational schemes and industry collaboration to drive the initiative forward. The task forces are critical, CiPPPA states, in bolstering collaborative efforts and utilizing member organizations’ expertise and resources to tackle the difficult environmental challenges around pharmaceutical packaging. Leading pharmaceutical companies, global over-the-counter (OTC) brands, and healthcare systems such as the National Health Service are closely involved with the initiative, signaling an “united industry commitment to influencing societal and cross-industry change for the benefit of the environment and the community” (1).

“Having previously sold thousands of tons of blister pack materials into the UK, and knowing that none of it was getting recycled, I became frustrated at the lack of sustainable solutions for the packs' end-of-life,” said Duncan Flack, Global Sustainability Lead at Honeywell and Chairman of CiPPPA, in the press release (1). “By founding and establishing CiPPPA, we are able to deliver enhanced end-of-life for blister packs and related pharmaceutical packaging such as metered-dose inhalers and injectables. The willingness of leading pharmaceutical companies and global OTC brands to support the initiative has been tremendous, and as CiPPPA continues to grow, so too does our ability to influence societal and cross-industry change.”

“We’re proud to be a founding member of CiPPPA and join forces with partners across the sector to address the sustainable packaging of medicines and vaccines,” said Claire Lund, vice president of Sustainability, GSK (1). “We have ambitious company targets across climate and nature and through collaborative initiatives such as CiPPPA, we believe we can make a positive impact through the increased recycling of packaging, helping to protect the health of both people and the planet.”

CiPPPA. Circularity in Primary Pharmaceutical Packaging Accelerator (CiPPPA) Launched to Take Collaborative Action on Pharmaceutical Packaging. Press Release. Apr. 24, 2024.

The non-profit initiative puts collaboration at the forefront as it tackles the challenges surrounding recycling primary pharmaceutical packaging.

UK Launches Circularity in Primary Pharmaceutical Packaging Accelerator Initiative to Implement Pharmaceutical Packaging Strategies

The European Medicines Association (EMA) and the European Commission’s (EC) Directorate-General for Health and Food Safety (DG SANTE) have signed a working agreement with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea in order to share confidential information on medical and medicinal products. This partnership will build on the close cooperation fostered between the two regulatory authorities during the COVID-19 pandemic and is intended as a step toward mutual recognition and regulatory harmonization as they work to improve human and animal health. The agreement also builds on the previously established ad-hoc arrangement, which ensured the exchange of medicinal information used for diagnosing, preventing, and treating COVID-19 and related infectious diseases.

The arrangement, which came into effect on Apr. 25, 2024, will allow participants to exchange sensitive information on medicinal products as part of their regulatory and scientific processes. This will include confidential information about the safety, quality, and efficacy of human medicines which have been authorized or are under evaluation, as well as information on inspections, regulatory guidance, and legislation. These types of confidentiality agreements can allow for faster exchanges of information on quickly emerging global issues, such as medicine shortages, quality concerns, and safety questions.These type of confidentiality arrangements, EMA said in a press release, “are the cornerstone of global cooperation” (1). This arrangement between the EU and Korea is valid for an indefinite period and will not need a renewal.

In its International Agreements page, EMA states that it has formalized its working relations with a number of third-country regulators through bilateral confidentiality agreements, which allows the parties to exchange confidential information and provide a framework for regulatory cooperation. “The emphasis,” the agency states, “is on exchange of information concerning regulatory guidance, legislation and non-public information on products, as well as safety information including adverse reactions, good manufacturing practice (GMP) and good clinical practice (GCP) inspection findings” (2).

EMA has listed the countries it has standing confidentiality agreements with, which are: Australia, Brazil, Canada, Japan, Switzerland, the United States, and now the Republic of Korea. It also has this agreement with the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe, and the World Health Organization (WHO). The agency states that it can also establish ad-hoc confidentially arrangements with international regulators to address specific public-health needs; such agreements have a limited scope and duration.

The agency also has signed several mutual recognition agreements on the conformity assessment of regulated products, which covers the mutual recognition of GMP compliance for human and veterinary medicines. These agreements aim to “facilitate market access while protecting consumer safety and encourage greater international harmonization of compliance standards” (2). EMA has signed mutual recognition agreements with Australia, Canada, Japan, New Zealand, Switzerland, and the United States. It has also signed this agreement with Israel, though the agency notes the agreement is on conformity assessment and acceptance of industrial products.

Confidentiality Arrangement between the EU and the Republic of Korea

ema.europa.eu/en/partners-networks/international-activities/international-agreements

The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities during the COVID-19 pandemic.

Confidentially Agreement Signed Between European Union and Republic of Korea Regulatory Bodies

Rentschler Biopharma DCAT video

Benedikt von Braunmühl (CEO) and Federico Pollano (vice president of business development) at Rentschler Biopharma explain what sets their CDMO apart. Viewers will learn about:

What exceptional CDMO expertise means: 25% of all FDA approved biopharmaceuticals in 2023 were supported by the company

Rentschler Biopharma’s US offerings, as well as commercial and development expertise

How the company is leveraging its expertise in the field of gene therapy

Explore how Rentschler Biopharma duels biopharmaceutical innovation, spanning from pioneering biological products to cutting-edge cell and gene therapies

Rentschler Biopharma: A 50-year Legacy of Exceptional CDMO Expertise

Beyond Expectations as a CDMO

to highlight the importance of working with Alcami. Learn more about: 

How Alcami stays ahead of the curve and makes the smart investments in capacity and technology to meet market demand and address sector challenges.

Understand Alcami's position to support the future of pharma and biotech, ready with innovative solutions and strategic partnerships that streamline and optimize the path to patients for clients’ therapeutics. 

Whether clients tap Alcami for one service or seek the benefit of a seamless end-to-end solution, the company’s Lab Services, Drug Product Manufacturing, and Pharma Storage and Services are fully integrated and optimized.

Bill Humphries (CEO, Alcami) dives into an overview of Alcami's capabilities and how they value their client's innovations. 

Alcami: Beyond Expectations

SK pharmteco, a contract development manufacturing organization (CDMO), has entered into a manufacturing and supply pact with Ferring Pharmaceuticals under which the CDMO will scale up manufacturing capacity for the drug substance of Adstiladrin (nadofaragene firadenovec-vncg), Ferring’s gene therapy for treating a form of bladder cancer. The companies will scale up capacity to commercial levels to ensure long-term future supply, according to company press release. 

Once technology transfer in complete, SK pharmteco, will be qualified as another source for the manufacture, testing, and release of the therapy, dependent on regulatory approval by FDA. FDA approved Adstiladrin in December 2022 (1) for treating adult patients with high-risk bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma 

 (CIS). The therapy is applicable for patients with or without papillary tumors.

“Ferring takes its responsibilities to patients with high-risk BCG-unresponsive NMIBC very seriously—especially when pioneering in the emerging field of gene therapy commercial manufacturing,” said Bipin Dalmia, global head, Uro-Oncology Franchise, Ferring Pharmaceuticals, in the April 18, 2024 press release. “Following our January announcement (2) of full availability of Adstiladrin across the US [United States] and expansion of our clinical trials program, this agreement with SK pharmteco comes alongside major investments in our own manufacturing capabilities to assure the breadth of our long-term supply base. Stable and sustainable supply is a vital part of our mission to fill this unmet clinical need for the patients we serve.”

In addition to this contract manufacturing agreement, Ferring Pharmaceuticals indicated in the press release that it is well underway with expanding dedicated capacity for the therapy at its facilities in Finland and in the US, where the company has a campus in Parsippany, NJ. The company expects to have updates on these capacity expansion projects later in 2024.

The increased prevalence of bladder cancer across geographies drives the need to scale up supply of strategically important bladder cancer treatments. The companies stated in the press release that, “The World Bladder Cancer Patient Coalition has reported that bladder cancer became the ninth most common cancer in the world (a rise from tenth) according to new data published in February 2024 (IARC GLOBOCAN 2022) [3].”

“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy Adstiladrin,” said Joerg Ahlgrimm, chief executive officer, SK pharmteco, in the release. “Our integrated approach, incorporating customizable clinical and commercial GMP [good manufacturing practice] manufacturing solutions with comprehensive in-process testing, quality control, and lot release programs, provides unparalleled support to our partners throughout their product lifecycle and is in perfect alignment with our mission of expediting the delivery of potentially life-saving therapies to patients across the globe.”

1. FDA. FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer. Press Release, Dec. 16, 2022.
2. Ferring Pharmaceuticals. Ferring announces full availability of ADSTILADRIN (nadofaragene firadenovec-vncg) in the US. Press Release, Jan. 16, 2023.
3. World Bladder Cancer Patient Coalition GLOBOCAN. GLOBOCAN 2022: Bladder Cancer 9th Most Common Worldwide. Press Release, Feb. 14, 2024.

SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.

SK pharmteco to Ensure Supply of Ferring Pharmaceuticals Gene Therapy

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N4 Pharma, a pre-clinical stage specialist pharmaceutical company, has formed a research collaboration agreement with SRI, a global R&D company, to increase intracellular delivery to specific target cells. The collaboration will combine N4’s Nuvec, a silica nanoparticle delivery system created to carry nucleotides to be developed as cancer therapies and vaccines, with SRI’s FOX Three Molecular Guidance System (MGS). The companies intend to co-market the combined technology and work to develop and follow new business opportunities collaboratively.

SRI’s MGS is a system that uses propriety technology to enable the delivery of macromolecular payloads first to target cells, and then to subcellular locations within those cells. It was designed to overcome cellular barriers that were stopping intracellular delivery of large-molecule biotherapeutics. SRI has successfully tested the MGS technology on more than a dozen macromolecular payloads, including functional enzymes, nucleic acids (such as small interfering RNA [siRNA], antisense oligonucleotides, and DNA), antibodies, nanoparticles, and liposomes. It has delivered these payloads to targeted, intracellular molecular-target locations that were previously considered unreachable.

Nuvec’s irregular surface structure allows the nanoparticle to trap and protect siRNA, RNA, and DNA in their delivery to the cell membrane. When it is inside the cell, it releases the genetic material into the cellular machinery, allowing for the chosen pathway response (protein transcription, protein silencing, or other immune response). When combined with MGS, there is potential to facilitate targeted and effective treatments in precision healthcare.

In an N4 press release, Kathlynn Brown, president of SRI’s Biosciences division, said, “We’re excited to work with N4 Pharma to advance nucleic acid therapies and expand the number of applications of their Nuvec nanoparticle technology using the FOX Three Platform. The key properties of Nuvec, including preventing enzymatic breakdown of nucleotides and large surface area allowing multiple copy number of cargo, together with the targeting provided by MGS, may significantly enhance the use of nucleotide therapies. This strategic partnership marks an exciting journey towards expanding treatment possibilities and transforming the landscape of biomedicine” (1).

We are delighted to be working with SRI and to have entered into this collaboration agreement. Combining our technologies successfully will lead to working with major pharma companies in the fields of oncology and vaccines with the exciting potential to develop novel products,” said Nigel Theobald, chief executive office of N4 Pharma. “SRI collaborates with a broad range of strategic partners from small and virtual biotechnology companies to top 10 pharmaceutical companies and other leading industry partners, which will give us unparalleled access to potential commercial partners on the back of any successful combined technology resulting from our research. This marks an exciting new chapter for N4 Pharma, and I look forward to providing further updates as the research work progresses, as well as on our other work streams such as oral applications of Nuvec and the development of ECP105 for an orphan indication with Nanogenics” (1).

N4 Pharma. N4 Pharma Announces Collaboration with SRI to Target and Treat Cells in the Human Body that Have Been Previously Unreachable. Press Release. Apr. 25, 2024.

The collaboration will combine N4’s nanoparticle delivery system with SRI’s molecular guidance system.

Featured Content

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

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach