Daria G. Husni

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

On April 16, 2024, at INTERPHEX 2024 in New York City, Wenyu Zhang, PhD, R&D Director, Berkshire Corporation, spoke about new trends in cleaning and disinfection of manufacturing environments and the factors that manufacturers must weigh when choosing cleaners and disinfectants. Zhang reviewed current practices along with their strengths and challenges, touching on chemicals, textile tools, and devices in use. He also went over new trends in the industry, and the chief concerns companies should keep in mind.

When talking about current challenges facing the sanitation sector, Zhang highlighted the five key concerns companies have when selecting aseptic products: overall effectiveness of the product; safety to both the equipment and those using it; environmental impact pertaining to hazardous waste, water and air contamination, and sustainability; the number of personnel needed to use the product and how much training they would require; and overall cost.

Currently, the industry relies primarily on chemical-based cleaners and disinfectants, such as solvents, detergents, sanitizers, disinfectants, and sporicides. Outside of water—which, while excellent for all key concerns, can only be used with water-soluble materials—organic solvents include alcohols, hydrocarbons, esters, ketones, glycols, and halogenated solvents. These products are usually inexpensive but can be dangerous to both the environment and users, as they are often petroleum-based and have negative health benefits. On the detergent side, surfactants are often used as a way to blend water and oil together. They give users a great deal of control over the combination variables, such as the speed that water enters the oil, how much foam is generated, and how long it lasts. Surfactants are a highly profitable field, making between $35 billion and $55 billion in 2022, but they are highly dependent on fossil fuels, and increase levels of aquatic toxicity and bioaccumulation, according to Zhang.

Just like organic solvents and surfactants, most current aseptic products have a cost. Chlorine chemistries are an affordable and effective cleaner with no lingering impact on the environment, but they have a limited shelf life and can be dangerous to use. Quaternary ammoniums, one of the most widely used types of disinfectants, are affordable, effective, and safe to use, but there have been recent debates on bioaccumulation and their long-term toxicity. This balance of pros and cons presents the opportunity for future products to fill those gaps.

As the industry looks to the future, it is more concerned than ever with the environmental impact of aseptic products, Zhang stressed. Companies and consumers have sustainability in mind when looking at products; so much of current aseptic development is focused on bio-based products and products with a lower environmental impact. Developers have begun creating sustainably sourced solvents, such as bio-based solvents, which are derived from renewable biological sources or agricultural by-products, or solvents made with greener manufacturing processes such as novel catalysis or biotech-driven processes. There are also ways to recycle and upcycle solvents. More environmentally friendly surfactants have also entered the market, such as biosurfactants, biobased surfactants, and conventional surfactants made with bio-based raw materials. Other biofriendly options for cleaning include natural or biobased disinfectants, sustainable textiles from natural or biobased fibers, and self-disinfecting and microstatic materials. Generally, these products tend to be more expensive than their more environmentally unfriendly counterparts, but as environmental concern continues to grow, many companies are turning towards biobased products.

But Zhang stated that the industry has a great deal of growing to do before biobased products can become the new standard. In some cases, they can actually be the worse environmentally mindful option, as the process needed to produce them uses more fossil fuels than synthetic-based products. It is important, he said, that companies don’t hone in on the bio option without taking the entire environmental impact in mind. There is a lot of work to be done on biobased products, but according to Zhang, the future looks promising. There are opportunities in current cleaning and disinfection practices for more effective, safe, and environmentally friendly options, and the industry is rising to meet them with greener and safer choices of cleaning chemistry.

Click here for more coverage from INTERPHEX 2024

Articles

Wenyu Zhang, PhD, addressed new trends in the aseptic industry and the chief concerns companies should keep in mind while weighing their options, at INTERPHEX 2024.

Disinfection of Manufacturing Environments: Balancing Efficacy and Cost of Cleaning with Safety and Environmental Impact (INTERPHEX 2024)

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

On April 3, 2024 FDA approved Zevtera (ceftobiprole medocaril sodium for injection) as a treatment for three types of bacterial infections: adults with 

 bloodstream infections (bacteremia) (SAB), adults with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients three months or older with community-acquired bacterial pneumonia (CABP). In addition to the approval, FDA also granted Priority Review and Fast Track and Qualified Infectious Disease Product designations to Zevtera. All trials for Zevtera were randomized, controlled, double-blind, and multinational; the SAB and CABP trials were also multicenter.

In the SAB trial, the measure of efficacy was overall success, defined as survival, symptom improvement, 

 bacteremia complications, and no use of other antibiotics, at a post-treatment visit 70 days after the patient was given an antibiotic. The study saw that 69.8% of patients who were given Zevtera achieved overall success, as compared to 68.7% of patients who were given the comparator. In the ABSSSI trial, efficacy was measured by early clinical response 48–72 hours after beginning treatment, which required the primary skin lesion to reduce by at least 20% with no other antibacterial treatments or surgery. Of the patients who received Zevtera, 91.3% achieved an early clinical response as compared to 88.1% of those who received the comparator.

The CABP trial measured efficacy with clinical cure rates at a test-of-cure visit, which took place 7–14 days after end of treatment, which lasted three days. Of the patients who received Zevtera, 76.4% achieved clinical cure as compared to 79.3% of patients who received the comparator. Another analysis allowed for an earlier timepoint of clinical success at Day 3 of treatment, which was 71% of patients receiving Zevtera and 71.1% of patients receiving the comparator.

 pathogen, can lead to life-threatening bloodstream infections, such as sepsis and endocarditis. The pathogen is opportunistic and colonizes human anterior nares. This pathogen is also present in ABSSSI, in addition to 

. ABSSSI are common and have symptoms that encompass a wide range of severities; infections are categorized as either complicated or uncomplicated skin and structure infections. In uncomplicated infections, patients can suffer from impetiginous lesions, furuncles, simple abscesses, and cellulitis. Complicated infections can cause infected ulcers, burns, and major abscesses, and often require surgical intervention alongside therapies.

CABP is a series infection and a prevailing cause of hospitalization and mortality. Mild cases can be managed as outpatients, but more severe cases require intensive care unit intervention (1). 

is one of the bacterial pathogens that can cause CABP, which can also be contracted via viruses and fungi (2). According to the National Library of Medicine, pneumonia is the eighth leading cause of death, with a mortality rate up to 23% for those with severe pneumonia admitted to the intensive care unit (3).

“The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections,” said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in FDA’s Center for Drug Evaluation and Research, in an FDA press release. “The FDA will continue our important work in this area as part of our efforts to protect the public health.”

Adults with SAB can experience a range of side effects from Zevtera, the most common being fever, vomiting, nausea, diarrhea, increased blood creatinine, high blood pressure, fever, fungal infection, abdominal pain, headache, shortness of breath (dyspnea), low levels of potassium in the blood (hypokalemia), increased levels of some liver tests (hepatic enzymes and bilirubin), and low white blood cell count (leukopenia). The most common side effects for adults with ABSSI include nausea, diarrhea, headache, increased levels of hepatic enzymes, rash, injection side reaction, vomiting, and altered taste (dysgeusia).

For adults with CABP, the most common side effects of Zevtera are increased levels of hepatic enzymes, vomiting, headache, rash, insomnia, nausea, abdominal pain, vein inflammation (phlebitis), high blood pressure, and dizziness. For pediatric patients, the most common side effects are headache, vomiting, diarrhea, infusion site reaction, increased levels of hepatic enzymes, vein inflammation (phlebitis), and fever.

The approval of Zevtera was granted to Basilea Pharmaceutica International Ltd.

Staphylococcus Aureus Bloodstream Infections: Pathogenesis and Regulatory Mechanisms

, 53 Feb 51-60. 10.1016/j.mib.2020.02.005.

Acute Bacterial Skin and Skin Structure Infections: Current Perspective

Zevtera has been approved to treat three types of bacterial infections and has been granted Priority Review and Fast Track and Qualified Infectious Disease Product designations.

FDA Approves New Antibiotic to Treat Three Different Bacterial Infections

3D Robot arm working automated in factory, industry 5.0 artificial intelligence computer aided manufacturing process control with computer digital technology modern futuristic background | Image Credit: © DIgilife - stock.adobe.com

The bio/pharma manufacturing industry is an ever-growing and evolving landscape, where emerging modalities and shifts in the field drive technological innovation. Advances in the field are clear to see from the approval rates by regulatory bodies, such as FDA’s Center for Drug Evaluation and Research, which approved 55 novel drugs in 2023 (1) for a variety of conditions. Therapeutic areas such as oncology and immunology are expected to dominate spending worldwide until 2027 (2) thanks, in part, to product innovations, improved patient outcomes, and increasing incidence of disease. Along with this market growth, cell and gene therapies, messenger RNA (mRNA) vaccines, and other new advancements have spurred innovations in every aspect of the pharmaceutical industry, including manufacturing of both small-molecule and large-molecule drugs.

Regarding current technological developments, Daniel Spurgin, director of Strategic Partnerships at ReciBioPharm, points to an industry need for speed, specifically through artificial intelligence (AI). “We’re seeing a rise in the utility of AI to monitor, control, and predict processes. However, AI technologies are only as good as the data they are trained on. Tightly controlled real data [are] essential to realizing the power of digital technology,” Spurgin says. “Autonomous decision-making allows processes to advance to next-unit operations without the need for quality gates and human intervention. In some cases, traditional release panels may be required based on regulatory positions, but the ability to autonomously advance processes would drastically improve the speed and quality of drug manufacturing, which is why FDA is funding MIT and ReciBioPharm to develop such capabilities for RNA modalities.”

Melanie Langhauser, team lead, Process Development DSP and Analytical Development, Ascend Advanced Therapies, has similar thoughts on the focus of the industry. “The biggest developments in manufacturing technology are focused on improving the productivity and efficiency of production processes while simultaneously boosting quality and reducing cost, particularly in the advanced therapies space, where robust, cost-effective, scalable processes are essential to future success,” she says. “Reducing the manufacturing costs is one important goal in our field, but what is even more important for our clients is to shorten the time to market.”

The bio/pharma market is moving towards greater integration of data analytics, machine learning, and AI, according to Oladimeji Fashola, chief technology officer, Quantoom Biosciences. This shift comes from a desire for process optimization, predictability, and a need for real-time decision-making. “Manufacturers are also focusing on personalized care vaccines/therapies,” he adds.

This focus is also seen by Cyrill Kellerhals, COO, Andelyn Biosciences, who states that personalized medicines require small batch manufacturing for increasingly smaller patient populations. He points to the emerging need to “tailor efficacy and limit side effects based on individual differences.”

But in the adeno-associated virus (AAV) manufacturing space, Langhauser reveals that current processes fall short. Manufacturers and equipment suppliers have been hard at work developing solutions, which include new engineered AAV serotypes, cell lines designed to produce AAV vectors, more efficient transmission systems and offline assays, and purification technologies designed specifically for viral vectors. Langhauser says that “the small intermediate volumes of the gene and cell therapy area are driving a clear need for equipment manufacturers to develop good manufacturing practice (GMP)-ready devices or solutions. And step by step, the manufacturers recognize that and develop solutions for the gene and cell therapy area.”

“What we still need,” Langhauser says, “are scalable single-use filtration solutions. [Because] a lot of filters are coming from the antibody world the first single-use filters are much too big for the advanced therapies space. We need smaller filters and filter holders in a single-use format. And to have a scale-down model of these filters for later robustness studies, we are up-scaling the filters more than necessary (the maximum capacity of these filters is not reached). So, we underload the filters even if we receive lower step yields.”

Avi Nandi, head of US Cell and Gene Therapy, SK pharmteco, also points to rising informational technology demands. “Manufacturers will need improved IT infrastructure to enable an integrated facility, accessible aggregate data repositories, automation and IT engineers, investment into analytical tools, and consider options to reduce overall [cost of goods sold] (like optimized suite design and process workflows to enable higher throughput operations as demands increase with more commercial approvals).”

In regard to the impact of new modalities, such as cell and gene therapies and mRNA, Fashola says, “The emergence of cell and gene therapies alongside mRNA vaccines has catalyzed substantial innovation not only in manufacturing technology but also in regulatory paradigms governing drug approval and market entry. Advancements are evident across scientific areas, particularly within cell and gene therapies, where techniques such as CRISPR [clustered regularly interspaced short palindromic repeats]-Cas9-mediated gene editing of stem cells are revolutionizing treatment modalities by correcting genetic mutations.”

“Furthermore,” he states, “mRNA technology has unveiled countless therapeutic possibilities, including vaccines targeting historically challenging diseases like HIV and cancer, thus representing a significant stride forward in biomedical intervention.”

Spurgin stresses the impact of cell-free DNA and bio-catalysis agents as critical raw materials for mRNA and cell and gene therapies. “Historically, plasmids have largely been derived from 

], which often requires significant development time and comes with a technology limitation (larger plasmids are more challenging to produce from 

),” he says. “The emergence of a cell-free plasmid DNA process significantly reduces those barriers. The same can be said about the emergence of enzymes and their use in manufacturing. They are making modalities such as xRNA more efficient, cleaner, and faster to manufacture.”

Advanced therapy medicinal products (ATMPs) can be more complex to understand and manufacture, specifies Nandi, who also points to more complexity in predicting clinical outcomes. ATMPs tend to have high cost of goods sold, aggressive timelines, and poorly understood product safety and efficacy. “As such, the technologies are diverse and rapidly evolving in response to improved understanding of these molecules with respect to product design, delivery vehicles, raw materials, cell lines, scalable technologies, analytical tools, etc.”

Nandi points to two main outcomes of ATMP development, the first being manufacturing success and the second being clinical data to validate manufacturing platforms. “We’re entering a time,” he says, “where clinical data, namely phenotypic determinants of response, will inform design of next-generation manufacturing technologies.”

In the continuous manufacturing space, Langhauser states that continuous processing for viral vectors is still in the beginning stage. “Companies are exploring the use of perfusion for intensifying the cell culture process prior to transfection. Making the transfection step continuous would be challenging, but for processes levering stable producer cells, running in perfusion mode is certainly possible. There is also potential for use of continuous chromatography techniques, while large-pore membrane and fiber-based media can enable process intensification, if not fully continuous operation. Some companies are already using single-pass tangential flow filtration to reduce process times and increase product recovery.” She stresses, however, that for continuous process development to be successful, one must have a “deep understanding” of the process. Process analytical technologies (PAT) and real-time monitoring are essential to keep continuous processes in control.

Spurgin concurs with the need for PAT and real-time monitoring. “Classical batched manufacturing contains a list of offline quality assays that gate manufacturing steps,” he says. “These transfers of samples and information are wasteful and slow and can negatively impact product quality where intermediates are unstable. Moving analytics from the lab and into the manufacturing stream aligns process steps with quality tests. Inline PAT can provide streamlined product characterization, real-time process monitoring and progression.”

The utilization of continuous manufacturing is on the rise, especially in the production of cell lines to create materials for vaccine and cell and gene therapy manufacture, according to Fashola. “This entails the use of continuous 

fermentation reactors that integrate with downstream processes for harvesting, lysis, purification, and filtration. Conversely, in the realm of mRNA vaccines, there is a concerted effort to enhance cost-effectiveness, throughput, and efficacy. To achieve these goals, continuous processes are being implemented from initial IVT [

 transcription] reaction through purification to encapsulation.”

AI has surged in a variety of industries in the past few years, including the pharmaceutical industry. Langhauser sees the technology growing in both drug development and manufacturing. “However, to be effective, AI systems must be constructed using large quantities of robust and truly representative data, otherwise any output they provide will be inaccurate and likely result in poor decision making,” she stresses. “As more processes are automated and the type of reliable data needed to build relevant AI models [are] generated, an inflection point will eventually be reached where AI systems will be able to predict everything from the general, such as the best combination of process steps, to the detailed, such as optimal process parameters, to the mundane, such as ideal preventive maintenance schedules.”

According to Spurgin, full-scale AI adoption still faces barriers. “AI is currently being leveraged across many early-stage drug discovery activities. The ability to select, screen, and characterize potential candidates was fairly easy to implement with no regulatory burden. It is different in the case of late-stage projects,” says Spurgin. However, he says that even though “AI’s most powerful use is in the manufacturing space,” regulators and manufacturers have been conservative with its implementation.

The perspective of regulators on the implementation of new and advancing technology is an important factor, agrees Langhauser. She believes that industry must show how technology can provide greater yield, improved quality, and faster time to market, all at a lower cost. “[FDA] is very interested in emerging technologies that will accelerate process development, improve quality, and lower costs,” she confirms. “The best approach is to collaborate with the agency, and if the new technology is provided by a supplier rather than developed in house, proactively seek to collaborate with the supplier as well as regulatory authorities so the technology that results truly is fit-for-purpose and regulators are aware, not only of the benefits, but of the entire effort involved in bringing the technology to the point where it is validated and proven to be appropriate for GMP manufacturing.”

“Product and manufacturing costs need to be carefully monitored and managed,” says Kellerhals, “to ensure continuing excellence and quality while being optimized for efficiency. Technology development is often faster than the regulatory environment, and in a risk adverse industry, adoption of new technologies can be challenging, and more so as you go from evolutionary new technologies to revolutionary new technologies.”

Kellerhals continues, “Decisions must be data driven—what are the advantages, what are the risks, what is the timing, and what are the quality and regulatory questions that must be addressed before a new technology is introduced and accepted.”

Advances in technologies can still lead to setbacks, warns Kellerhals. “Often, new analytical technologies provide breakthrough abilities to better develop or characterize new drugs, but there can be lags in time before those technologies or instrumentation are mature enough to be implemented in GMP settings,” he states. “This results in challenges implementing the newest or the best analytics in early phase clinical productions.”

“The biopharmaceutical industry is conservative in nature, so some technologies, particularly those that may raise questions from regulators, are slow to be adopted,” says Langhauser. “Manufacturers must weigh the risks associated with regulatory uncertainty against the benefits any new manufacturing technology may bring.”

“Looking specifically at technology challenges for viral vectors, the biggest hurdle for those companies using transient transfection, given the inherent nature of this process, is boosting the titer while simultaneously achieving selectivity for full capsids, and doing so at large scale,” Langhauser adds. “Progress has been made … but there is much more to do.”

. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023

Statista. Projected Top Therapy Areas Worldwide in 2027, by Spending. 

https://www.statista.com/statistics/281951/top-therapy-classes-in-developed-pharmaceutical-markets-by-spending/

When referring to this article, please cite it as Husni, D. The Growing Future of Drug Manufacturing. 

With an ever-growing market driving technological advances, there is always work to be done in drug manufacturing.

The Growing Future of Drug Manufacturing

In Modern Laboratory Senior Female Scientist Has Discussion with Young Male Laboratory Assistant. He Shows Her Data Charts on a Clipboard, She Analyzes it and Enters It into Her Computer. | Image Credit: © Gorodenkoff - stock.adobe.com

In outsourcing, a partner well versed in clinical trial materials (CTMs) can be a valuable asset. But there are other considerations companies may want to take before seeking out a service provider. Pharmaceutical Technology® spoke to Jason King, director, BD at Ascend, on the various aspects of working with a partner for CTM, from the advantages of CTM to region-specific barriers potential partners could face.

 Could you please run through the key benefits of working with an outsourcing partner for CTM?

 Working with an outsourcing partner allows a team to immediately build forward with the know-how of expert teams instead of having to build capacity and hire more internal capability in a highly competitive sector. Outsourcing CTM also allows product development companies to focus on developing new product candidates while moving the existing ones forward via the outsourcing partner. This helps to optimize what every member of the internal and external team is good at, while saving time and money in these earlier stages. And if/when products move forward with an outsourcing partner, they should be going to into a clinically validated and therefore de-risked manufacturing platform, saving more time and money over the life of the process.

 Can there be separation in what can be outsourced, as in the manufacture of CTM, the packaging, analytical services, testing, and so forth? Can such a separation be advantageous, or do you think it is better to request a more full-service package from a contract development and manufacturing organization (CDMO)/contract manufacturing organization (CMO)?

 Yes, and this happens quite often since many clinical manufacturers do not have on-site capacity for all the analytical and testing services required. Though it is most efficient to select a provider that can do it all, it is still beneficial to have samples tested by a second provider for risk mitigation purposes. Separation will even be necessary in instances where CTMs are manufactured and released outside the EU [European Union] as drug product testing or for CTMs used in EU clinical trials that require EU release testing.

The modality will matter here, because we see that fill/finish providers for ATMPs [advanced therapy medicinal products] are still comparably rare, and the analytical/testing side is less mature. So, in many cases, a customer may have no choice but to have multiple providers as the advanced therapies space continues to evolve.

 Do you think there are advantages or disadvantages to employing more than one services provider for CTMs?

 The modality and the global demand for a product will be part of this consideration.

In the aftermath of the COVID pandemic, it became clear that multiple providers of clinical manufacturing can be valuable in reducing the supply risks. For a modality like cell therapy, this is particularly true when the product being manufactured is complex and needs to be made close to the site of the clinical administration.

When you are working with global patient populations and manufacturing networks, the logistics of manufacturing and testing can become more complicated and require numerous sites. For example, when performing stability studies, a sample may need to be shipped to another facility.

Are there specific regulatory requirements that companies should be aware of when partnering with a service provider for CTMs? For example, regional-specific variances that could prove problematic later down the line?

 There are different requirements for GMP [good manufacturing practice] manufacturing facilities in the [United States] and EU that need to be considered when a product is intended to be used in multinational clinical trials. There can be differences in the things such as the duration that retain samples should be held for, or the minimum reference sample size to comply with the number of times the complete analytical controls can be repeated. There can also be differences in interpretation of the regulations around facilities, particularly the revised EU Annex 1. The FDA has no obligation to comply with the Annex 1 requirements; however, it states publicly that it is aligned with the principles of Annex 1.

 Could you provide some useful tips/best practices for companies to follow who may be seeking out a service provider (or more than one) for their CTM needs?

 Sourcing a cell and gene therapy CDMO can be trickier due to the maturity of the market. The customer must consider the specific know-how/IP ownership clarification and find a manufacturer strongly focused on product quality. The CDMO should have a flexible tech platform, ideally including the analytics needed. Providers with good analytics development teams are even more critical when bespoke assays are needed for specific gene expression assays or gene therapy potency assays.

While it matters, speed should not be the main focus in these relationships. It has to be quality and longevity or what a recent article called the ‘3 Cs’: capacity, comparability, and capability (1). Does the provider have the space (capacity) to support your product with the ability to complete tech transfers and perform comparability exercises where needed? And do they have platform modularity and adaptability and human expertise (capability) to meet needs and ensure risk is mitigated for the life of the product?

Welch, A.R. From Capacity to Comparability: The Shifting Onus in Cell & Gene Therapy Outsourcing. CellandGeneCollaborative.com. Sept. 18, 2023.

When referring to this article, please cite it as Husni, D. Taking Full Advantage of Service Providers. 

There are considerations companies may want to consider before seeking out a service provider.

Taking Full Advantage of Service Providers

Over the past few weeks, there have been many facility expansions and announcements in the manufacturing sphere. 

 gives a brief overview of some of the developments in manufacturing facilities, including news from W.R. Grace & Co, ITT Inc, and SMC.

On Mar. 18, 2024, W.R. Grace & Co. (Grace), a global specialty chemicals company, announced the completed expansion of its fine chemical contract development and manufacturing (CDM) facility located in South Haven, Missouri. The facility produces APIs, regulatory starting materials (RSMs), and drug intermediates, while staying compliant with FDA’s Current Good Manufacturing Practice (CGMP) regulations. The completion of the 21-month project adds 25% more capacity to the facility, which has cleared the way for the addition of a 4000-gallon Hastelloy centrifuge and three 4000-gallon, multi-use chemical reactors. With these additions, Grace aims to fill a growing demand for APIs.

“The additional capacity and cutting-edge equipment in South Haven bolster our ability to grow with our current and future customers through every stage of fine chemical manufacturing—from research and development to clinical trials, scale-up services and commercial production of custom molecules and compounds,” said Brenda Kelly, president, Materials Technologies, Grace, in a Grace press release.

On March 21, 2024, ITT Inc. (ITT), a manufacturer known for centrifugal and twin-screw pumps, announced an $11 million expansion of its testing capabilities at three of its industrial process (IP) sites. This expansion of the sites, located in Obernkirchen, Germany, Vadodara, India, and Dammam, Saudi Arabia, aims to increase capacity for large project awards in its flow business. The increase in pump, motor, and control systems testing power capacity will allow ITT to locally test larger and more complicated pump packages.

According to a company press release, the investments at ITT’s Goulds Pumps sites in Saudi Arabia and India aim to facilitate future growth in line with ITT’s ‘in region, for region’ strategy. At the company’s Bornemann pumps site in Germany, ITT plans to use the expansion to “replicate field conditions through complete unit multiphase fluid testing.” These expansions are expected to be completed in the third quarter of 2024.

“These strategic investments will further enhance our capabilities and customer experience and continue to differentiate ITT from the competition,” said Luca Savi, ITT’s chief executive officer and president, in the press release. “Our added capabilities will be a critical part of our commitment to becoming the preferred global flow provider by offering a superior solution through innovation, world-class customer service and flawless execution.”

Instead of expanding existing facilities, some manufacturers are acquiring new ones. On March 13, 2024, SMC, a contract manufacturer of single use and disposable medical devices, announced the acquisition of an end-to-end fill/finish facility in Charlotte, NC. The facility is intended to provide SMC with a wider range of services that it can offer, including device manufacture, fill/finish, final assembly, lab-to-market development, analytical services, and secondary packaging. SMC aims to use the new facility to offer high-speed, sterile fill/finish lines with onsite formulation, compounding, and packaging services.

“SMC is recognized globally for its ability to deliver complex, complete drug delivery systems with unrivalled speed and agility,” said VP and general manager, Uri Baruch in an SMC press release. “This acquisition not only adds to this capability, it reaffirms our commitment to the pharma market and completes another phase of our growth agenda.”

Pharmaceutical Technology gives a brief overview of some of developments in manufacturing facilities, including news from W.R. Grace & Co, ITT Inc, and SMC.

Manufacturing Facility Updates

Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept | Image Credit: © Dilok – © Dilok - stock.adobe.com

On Mar. 25, 2024 Univercells announced a collaboration with Altamira Therapeutics, a producer of nanoparticle-based technology, under which Univercells will use Altamira’s SemaPhore nanoparticle platform to deliver messenger RNA (mRNA) vaccines. Also on Mar. 25, Andelyn Biosciences, a contract development and manufacturing organization (CDMO), announced a partnership with Grace Science, a biotechnology company focused on developing novel therapies based on N-Glycanase 1 (NGLY1), an enzyme critical to proteostasis.

Using Altamira’s SemaPhore nanoparticle platform, Univercells will first test an 

 proprietary mRNA vaccine. If successful, the companies plan to negotiate a commercial agreement for the development and manufacture of nanoparticle-based mRNA vaccines using Univercells’ production platform.

“We’re delighted to be partnering with Altamira to explore better ways to deliver mRNA to patients,” said José Castillo, PhD, Chief Technology Officer of Univercells, in a Univercells press release. “mRNA vaccines, and mRNA in general, have proven to be a game-changer in how we prevent, treat, and cure diseases in a range of fields from oncology to infectious diseases. To unlock its full potential, however, we need constant innovation to make mRNA products more effective, efficient, and affordable. One key step is to develop platforms that use lower doses of mRNA.”

Andelyn Bioscience and Grace Science are partnering to tech transfer and manufacture GS-100, which is a suspension process adeno-associated viruses (AAV) NGLY1 gene therapy. GS-100 is being developed to treat patients with NGLY1 deficiency. The aim of this partnership, according to Andelyn, is to maximize program efficiency, support the ongoing clinical trial, and accelerate the therapy to patients.

NGLY1 deficiency is a life-threatening disease that has no approved therapy, according to a company press release. NGLY1 is a cytosolic enzyme critical to removing N-linked glycans of misfolded N-glycoproteins. The enzyme is part of endoplasmic reticulum-associated degradation (ERAD), a component of protein quality control in which misfolded and potentially toxic proteins in the endoplasmic reticulum are eliminated. Patients with this deficiency suffer from debilitating symptoms such as cognitive impairment, developmental delay, hypo alacrimia, movement disorders, and other neurological issues.

GS-100, a recombinant AAV9 vector that encodes a full-length version of the human NGLY1 gene, was granted orphan drug designation by FDA and the European Medicines Agency in 2021. FDA also granted the therapy rare pediatric disease designation in 2021 and fast-track designation in 2023. Andelyn’s knowledge of AAV processes and late-stage manufacturing are a key part of the upcoming partnership, which is focused on quality control while also accelerating Grace’s manufacturing timelines.

Matt Wilsey, CEO and co-founder of Grace Science stated in an Andelyn press release, “We are very excited about the partnership between Grace Science and Andelyn Biosciences. Andelyn’s deep expertise and experience in AAV gene therapy manufacturing will assure that our NGLY1 patients have access to safe, high-quality drug product for our clinical trial and beyond.”

“Both Andelyn and Grace Science value strong collaboration and share a customer-centric focus and quality-first mindset,” added Matt Niloff, chief commercial officer at Andelyn Biosciences, in the press release. “These synergies provide patients and their families confidence and hope for success of the GS-100 program.”

Univercells and Altamira Therapeutics are collaborating on nanoparticle-delivered mRNA vaccines, while Andelyn Biosciences and Grace Science are partnering on novel therapies for NGLY1 deficiency.