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

Felicity Thomas

Biosynth—supplier of critical raw materials to the life sciences industry—has acquired Cambridge Research Biochemicals (CRB)—an independent producer of custom-made peptide and antibody tools. The acquisition was announced in a May 9, 2023 press release.

Through this acquisition, Biosynth will gain CRB’s expertise in complex peptide chemistry and fluorescent dye labeling, bolstering its peptide division, which has existing operations in the United States and the Netherlands. Additionally, CRB’s custom antibody capacity in Europe will provide further support to Biosynth’s customers through the generation of novel, complex, or unusual mono- and polyclonal antibodies that are not available in catalogs.

“CRB has a long history in the peptide and antibody field, and we are excited to welcome their highly skilled team to our growing peptide division,” said Urs Spitz, CEO and president of Biosynth, in the press release. “Having a network of peptide sites at key locations, staffed by industry experts, allows us to best serve our customers throughout research and development and with the most complex and labelled peptides and high-quality antibodies.”

“We are excited to be joining the Biosynth family,” added Emily Humphrys, managing director of CRB, in the press release. “As one of the longest established peptide companies, we have over 40 years of experience and are proud to have a strong track record for peptide and antibody excellence with our customers. We see great similarities in the approach that Biosynth already take in leading with science and customer focus.”

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Critical raw materials supplier, Biosynth, has acquired UK-based Cambridge Research Biochemicals (CRB).

Biosynth Acquires Cambridge Research Biochemicals

Global contract development and manufacturing organization, Vetter, has announced its plans to further expand its production capacity and services at its Rankweil, Austria site, in response to increased market demand.

According to a May 9, 2023 press release, the company will be implementing additional equipment for aseptic production and will be expanding the storage capacity at the clinical site based in Austria. A second autoclave and washing machine for material preparation will be implemented to expand cleanroom utilization. Additional freezers are also being purchased to improve cold storage capacity.

Further, Vetter will also be able to process powdered substances at the Rankweil site thanks to the implementation of an isolator, and the clinical filling portfolio is set to be expanded with a greater number of options for primary packaging materials. With these plans for expansion, the company believes that it will be able to increase the production volume of the facility by more than double in 2023 when compared with 2022.

“In addition to our existing clinical manufacturing facility in Chicago, Rankweil has established itself in a very short time as a strategically important location for us and our partners,” said Claus Feussner, senior vice-president, Vetter Development Service, in the press release. “Customer service, efficient processes, and our high-quality standard are the focus.”

Vetter is further expanding its production capacity and services at its Rankweil, Austria site.

Vetter Prepares to Further Increase Production Capacity and Services at Austrian Site

Novel and emerging biotherapeutics are commanding a larger portion of the development pipeline at an inflated rate. As drug companies focus greater efforts on these complex therapies, regulatory authorities have been working on various guidelines to ensure these drugs are manufactured to a high level of quality with minimum risks. Focusing on good manufacturing practices (GMPs) for emerging therapies across the United States and the European Union (EU) in particular, 

 spoke with Elena Meurer, principal consultant at Biopharma Excellence, to learn more about current regulatory expectations, the evolution of guidelines, and potential regional variances.

 Could you provide an overview of current GMP expectations for emerging therapies?

 Both FDA and the European Medicines Agency (EMA) have published regulatory guidelines related to the implementation of GMP across the different clinical phases (1,2). Many emerging therapies fall under the definition of advanced therapeutic medicinal products (ATMPs) in the EU or cell and gene therapies in the US. Only EMA has published specific GMP guidance that is applicable to the manufacture of ATMPs.

When assessing the required application of GMP in clinical phases, there are many similarities between the EU and US GMP requirements in that they both focus on the identification and assessment of the risks to the quality of an investigational phase medicinal product. The main difference between the EMA and FDA approaches is the recognition by EMA that ATMPs require explicit GMP guidelines that take the specifics of this product class into consideration, and places a heavy emphasis on a risk-based approach for the broad application of GMP across the product lifecycle (2). It is important to note that not all emerging therapies are classified as ATMPs. Nevertheless, as with ATMPs, such novel therapeutics may also require specific manufacturing solutions that should be addressed case by case in a risked-based manner.

The vast majority of emerging therapies are developed as sterile drugs and, due to the heat sensitivity of many of these therapies, final sterilization is not feasible. Therapeutics in this class are usually sterile filtered (unless they are cell-based therapies and this is not possible) and are manufactured through aseptic processing using modern barrier technology including single-use fluid pathways and isolators, for instance.

Early clinical research is likely to be more relevant for the discussion about emerging therapies. While quite a few cell and gene therapies have moved into later clinical phases and beyond, there are new examples of emerging therapeutics such as extracellular vesicles, peptide-based vaccines, complex molecules produced by chemical synthesis, or approaches using combinations of different technologies in the development/research phases.

For early clinical phases, patient safety is a primary focus. For many emerging therapies that are sterile, fully validated aseptic manufacturing processes are required to support clinical supply, even for Phase I. There is more flexibility in areas that do not have a direct impact on patient safety such as QC [quality control] method validation, where verification may be sufficient but, at the outset, a phase-appropriate GMP assessment is required—to determine the areas where full GMP is required to ensure patient safety, and balance these areas with others that may require less rigor for the clinical program. This approach is valid for both regulatory regions—EU and the US—but in practice expectations can differ depending on the inspector and their knowledge of the product. This can be one benefit of the expedited pathways available from FDA and EMA which include built-in scientific meetings for exchanges of information between inspectors and clinical researchers—long before an MA/IND [marketing authorization/investigational new drug application] is granted and an inspection is scheduled.

 How has the guidance for GMPs for emerging therapies evolved over recent years?

 Over recent years, the landscape for the regulation of GMP has changed in response to innovation and the broader range of therapy types being developed. Due to the huge variety of platforms and technologies, a ‘one size fits all’ approach is no longer practical nor feasible. With this change, the emphasis is being placed on the identification, assessment and control of risk. This has been a major focus in the revision of key guidance documents such as the 

 Volume 4 Annex 1 ‘Manufacture of Sterile Products’ and the recent revision of ICH [International Council for Harmonisation] Q9 on quality risk management (QRM) (3,4). Each revised guidance document includes a much more focused emphasis on managing the risk to product quality to safeguard patients.

The introduction of the European guidelines on GMP specific to ATMPs demonstrates a recognition of the difficulty in legislating for ATMPs, and of the important role QRM plays in the future regulation of all emerging therapies (2).

 Are any major changes to GMP guidance for emerging therapies expected in the near future?

 The GMP for ATMP guidance published for the EU was a good start, in recognizing that GMP manufacturing of innovative drugs requires more flexible guidance to account for all different modalities. However, not all emerging therapies are covered by the ATMP guideline. One good example is personalized cancer vaccines consisting of peptide-based neoepitopes. Such therapies do not fall under the ATMP definition, yet share many common features—such as manufacturing and testing challenges imposed by their small batch sizes. Most importantly, the composition of each batch of such a personalized therapeutic differs, which requires a special approach (e.g., to their validation and stability studies).

Another important development is the increased use of prediction programs using artificial intelligence in designing personalized therapeutics. These emerging applications should drive adaptations of existing GMP regulations to further develop approaches for algorithm validation in a GMP environment, for example.

There are also more subtle changes that are already occurring such as the widening of the scope of Annex 1 in terms of applicable territories and manufacturing platforms. This further highlights the acceptance, particularly between the US and EU, that a more common approach is needed for the regulation of GMP for all product types, not just emerging therapies.

It is also evident, based on the focus on QRM in the industry, that this will be the driver for future GMP regulation—rather than relying on unilateral instructions for an industry that is now highly diverse.

 Are there specific differences between the GMP guidance for emerging therapies in the US versus Europe and other parts of the world?

 There are no specific GMP regulations for emerging therapies in the US; this is a gap currently. The GMP applied to US emerging therapies is interpreted from existing regulations, and the US is now placing more focus on the application of QRM for emerging therapies that have unique or unusual characteristics that impact GMP. In the EU, there is an existing document (2), which although set apart from the existing GMP regulations contained in EU GMP Volume 4, is largely an amalgamation of existing documents, in addition to references relating to application of QRM where black and white guidance is impossible or unavailable.

The situation in other territories is very similar, where there is a recognition that emerging therapies can be unique in terms of the practical application of GMP. The US and EU are leading the way in recognizing the unique challenges posed by emerging therapies, and the standards that need to be applied during their manufacture.

However, it should be noted that The Pharmaceutical Inspection Convention Scheme (PIC/S) has adopted the relevant EU guidance documents including the guidance entitled ‘Manufacture of advanced therapy medicinal products for human use’ which is denoted as Annex 2A and is equivalent to the standalone 

 guidance (5). This adoption brings these regulatory expectations to a large cohort of global regulatory authorities. With the availability of this guidance across a large part of the global pharmaceutical industry, the main difference will be in the local application and interpretation of these industry standards.

 Will there be greater harmonization between regions on GMP guidance for emerging therapies in the future in your opinion?

 The vast majority of emerging therapies address very specific patient groups that require global recruitment (e.g., rare diseases) or unmet medical need which is of high interest for all regulatory regions. Thus, harmonization in the GMP guidance is of the utmost importance and should be driven by the therapeutic needs, as it would significantly simplify clinical manufacturing and supply in addition to safeguarding patients and ensuring a global standard of care for equivalent patients in different countries. The agencies of major regulatory regions are in regular contact, and must be aware of these emerging needs.

Several actions are needed to progress the regulation for emerging therapies, such as the need for scope expansion for mutual recognition agreements between the EU and several other countries globally to include ATMPs and blood products. The adoption of Annex 1 by FDA and PIC/S shows the direction of travel in terms of harmonization, and is a positive step in ensuring that future regulation is likely to be global rather than local. This promises to benefit patients in all countries, while reducing the regulatory burden of trying to satisfy a myriad of differing expectations when trying to get an emerging therapy to patients.

Current Good Manufacturing Practice for Phase 1 Investigational Drugs

. Guidance for Industry, July 2008.
2. EC. 

Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products.

Manufacture of Sterile Medicinal Products

. Final Version, January 2023.
5. PIC/S. 

Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use

Felicity Thomas is the European/senior editor for Pharm Tech Group.

When referring to this article, please cite it as Thomas, F. Optimizing the Manufacture of Emerging Therapies. 

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

Optimizing the Manufacture of Emerging Therapies

At the time of writing, countries throughout Europe are being brought to their knees through strike action being taken by employees from various sectors who are unhappy about low pay and poor working conditions. Teachers, nurses, doctors, train drivers, pilots, airport staff, and civil servants, to name a few, are holding mass walkouts from their jobs, ensuring that their demands are heard by the relevant authorities.

Over the years, the bio/pharma industry has not been subjected to much industrial action from its workers, particularly not when compared with professions based in the public sector. In fact, when looking back, the most notable disruption to the industry occurred in 2010 when there was a spate of disputes affecting three major pharma companies—AstraZeneca, Sanofi, and Merck—where employees fought back against job cuts and unfavourable benefits (1).

However, this year is proving to be bucking the trend. At the beginning of May 2023, GSK employees staged a series of walkouts that, at the time of writing, were expected to last throughout the month and impact a number of the company’s plants in the United Kingdom. Strike action started at Montrose on 2 May and spread to GSK’s plant in Irvine on 4 May, with the Ware, Barnard Castle, Worthing, and Ulverston facilities following suit at later dates in the month (2).

Indeed, it was only a year ago, in May 2022, that GSK managed to narrowly avoid strike action due to a dispute over pay, when negotiations with the workers’ union, Unite, ended in an improved offer that was accepted (3). This new action by GSK workers in 2023 demonstrates the current financial strain many people are facing in the UK and Europe as a result of the rate of inflation and general cost of living increases. To that point, according to the UK’s Office for National Statistics, when taking inflation into consideration, the real value of regular wages has actually fallen by 2.5% between October and December 2022 alone (4).

Inflation in Europe—although declining slightly from the peak level—is set to remain high for now, and economic growth is spluttering along at a painfully slow pace (5), meaning that the cost of living will not improve for working people in the region for some time. Only time will tell whether the bio/pharma industry will succumb to further industrial action by its workforce or not.

1. Reuters. European Staff Fight Back as Drugmakers Hack Costs. News Release, 17 Aug. 2010.
2. Unite. GSK Strike Wave Across the UK Begins in Montrose. News Release, 1 May 2023.
3. Unite. Strike Off as Unite Secures Pay Lift for GSK Workers. News Release, 23 May 2022.
4. King, S.; Crees, M.; Ball, C.; Gabriadze, M. The Impact of Strikes in the UK: June 2022 to February 2023. 

, Article, 8 March 2023.
5. Kammer, A. Europe’s Knife-Edge Path Toward Beating Inflation Without a Recession. 

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.

When referring to this article, please cite it as Thomas, F. On Strike! 

Strike action is impacting numerous sectors across Europe, including the bio/pharma industry.

On Strike!

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Hanns-Christian Mahler, CEO and board member, and Andrea Allmendinger, chief scientific officer, both at ten23 health—a contract development and manufacturing organization dedicated to human-centric and sustainable pharmaceutical development—about some of the hurdles facing developers and manufacturers of biological therapies. Hanns-Christian and Andrea take a closer look at some of the solutions being used within industry to overcome these challenges and focus on the issue of sustainability within this sphere. Finally, they touch upon some of the other potentially important future trends that will impact biologic drug development and manufacturing.

Hanns-Christian Mahler is Chief Enablement Officer (CEO) & Board Member, ten23 health

. Mahler’s previous roles include the head of Drug Product Services at Lonza, head of Pharmaceutical Development and Supplies at Roche, and principal scientist of Pharmaceutical Development and CMC Project Manager Erbitux for Merck KGaA. He holds a PhD in Toxicology from the Institute of Pharmacy at the University of Mainz and is an adjunct faculty member and lecturer at the universities of Frankfurt and Basel. He obtained his venia legendi (German Habilitation) from the University of Frankfurt/M. in 2011. Mahler also serves on the boards of Bionter and KriyaBio, and is an editor for several pharmaceutical journals.

Andrea Allmendinger, PhD, Chief Scientific Officer at ten23 health.

 Dr Allmendinger is also Adjunct Professor and Group Leader at the University of Freiburg (Baden-Württemberg, Germany), researching novel parenteral drug formulations and device solutions to improve stability, usability and cost of goods. Between 2010 and 2021, she was Principal Scientist, Pharmaceutical Development at Roche, working on, inter alia, manufacturability and injectability of high-concentration protein formulations, formulation and process development of freeze dried formulations, syringe and high volume drug/device combination products, particulates and surfactant strategy. Dr Allmendinger studied Pharmacy at the University of Heidelberg, Germany, and University College London, UK, and holds a PhD in Pharmaceutical Sciences from the University of Basel, Switzerland. She obtained the venia legendi (German Habilitation) from the University of Freiburg in 2021, and serves as Editor-In-Chief for the AAPS Open Journal.

 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, Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Drug Solutions Podcast: Considering Biologic Drug Development and Manufacturing Holistically

Bio/pharmaceutical manufacturers have been required to pivot in recent times because of a number of factors, including the shifting focus of drug development to next-generation modalities, pressurized supply chains, increasing adoption of digitalization, and intensified efforts to be more sustainable (1). One event that has thrown up hurdles and required novel solutions in response has been the COVID-19 pandemic, which has had an influence on all aspects of industry across the globe.

Despite the disruptions and uncertainties caused by the pandemic, the bio/pharmaceutical manufacturing sector has advanced and evolved, balancing the fluctuations correspondingly to mitigate risk and allow for further progression. According to research, for example, the bio/pharmaceutical manufacturing market should witness compound annual growth in the region of 11% between 2022 and 2027 (2), thanks in part to advancing manufacturing technologies.

“There have been a couple of significant shifts in the industry,” stresses Dan UpDyke, strategic marketing manager, Life Sciences, Rockwell Automation. “In years past, it was typical to build purpose-built, single product facilities. These would have fixed vessels and be designed with rigid processes to deliver repeatable results but had limited flexibility. As drug development has shifted to highly specialized treatments with smaller patient populations, the need for flexible and scalable systems has become a focus leading to solutions such as single-use technologies.”

Precision medicine and other next-generation modalities, such as cell and gene therapies, have been a focus for the bio/pharmaceutical industry over the past decade, remarks Bryan Deuber, senior director, Business Development and Strategic Partnerships, Andelyn Biosciences. “In response, outsourced development, manufacturing, and testing organizations have adjusted their models to accommodate the flexibility of serving both relatively small-batch manufacturing and larger indications,” he states. “Many therapeutics behind the recent growth require an extremely skilled workforce, state-of-the-art technologies, and advanced consumables, including plasmids and viral vectors.”

These new modalities and platforms—messenger RNA (mRNA), cell and gene therapies, and so on—also require delivery in multiple dosage forms, such as autoinjectors, syringes, and vials, and new patient distribution models, specifies Sridhar Krishnan, vice president, The Catalent Way at Catalent. “Manufacturers must be able to integrate this wide range of needs into their operations,” he says.

“Most recently, biopharmaceutical manufacturing has been impacted by pressures on supply chain,” specifies Antonio Crincoli, vice president of Engineering, Pharma and Consumer Health, Catalent. “The expectation from customers is for consistent, resilient, and predictable supply chain performance, at a high quality and a reasonable cost.”

Although Jade Byrd, director of Industry Marketing at Agilent Technologies, also points to the drive toward better risk management by the manufacturing community because of the scrutiny over supply chains over recent years, which is reducing the risk of drug shortages, as a key trend, she believes that the most impactful change is the move to continuous manufacturing. “The same number of doses can be produced in much smaller facilities, leading to both reduced costs and less waste,” she says.

“The pandemic had a major impact on pharmaceutical manufacturing, forcing organizations to think differently about treatment manufacturing,” continues Nathan Pettus, president, Process Systems and Solutions, Emerson. “COVID brought supply chain issues to light, and that revelation created a push for more regional manufacturing, instead of making everything in one place. By creating more regional manufacturing hubs, many pharmaceutical manufacturers are significantly de-risking their supply chains to minimize disruptions.”

For Shankar Gupta, chief sales officer, ACG, it is the globalization of the bio/pharmaceutical industry that has led to the advent of new manufacturing hubs with rising cross border sales. “Encouragingly, this growth has brought with it a real focus around quality and inspection,” he adds.

However, according to Thomas Schmidt, marketing director, Digital Solutions, Agilent Technologies, despite the existence of lean Six Sigma and quality-by-design initiatives to ensure better product quality for some time already, these tools have not always been used to their full potential, perhaps as a result of the change management they require.

“Regulatory expectations are increasing,” emphasizes Krishnan, “and as a result, manufacturers must look to meet the highest regulatory standards to be able to supply to all markets. Accordingly, there is a focus on quality management systems that ensure data integrity and governance, and that digitization occurs with appropriate validation, also, where necessary, that there is segregation of operating systems to eliminate risk of corruption.”

Customers are also placing greater importance on speed-to-market for products and flexibility of supply, notes Crincoli, meaning that manufacturers must be capable of quickly deploying or transitioning manufacturing assets to meet market needs. “It is therefore beneficial if facilities and equipment are designed to handle multiple products or dose forms. Similarly, there must be the ability to quickly move from development to commercial operations through scaling up or scaling out,” he says.

In fact, the speed at which COVID‑19 vaccines were created and manufactured demonstrated to the world that it was possible to launch new products at pace, confirms Pettus. “While much of that speed was enabled by emergency authorization regulation changes and special funding, life sciences companies have now seen what is possible, and they want to find additional ways to safely develop and manufacture other essential treatments much faster,” he states.

Another big movement for bio/pharmaceutical manufacturing has been investment in the digital transformation, adds UpDyke. For many years, technology innovation has been slow, with equipment and processes becoming “standard,” until recently when the business value of digitalization is being realized, he affirms.

Focusing on the fact that companies are looking to operate in more regionalized facilities, work with a greater number of contract development and manufacturing organizations (CDMOs), and develop more niche markets, Pettus points out that they will have many more batches to track and products to manage. “The massive amounts of data generated by these information-intensive methods will need to be contextualized so manufacturers can glean innovative and more efficient ways to ensure they are operating in a cost-effective, reliable, and quality-compliant manner,” he says.

A useful tool that will empower manufacturers to take advantage of additional data not previously collected is process analytical technology (PAT), which enables inline monitoring and real-time release, Pettus continues. “With the application of these technologies—instead of performing sampling processes, waiting for in-process testing before proceeding to the next step, or waiting for final batch test results to proceed with or release the batch—much of the critical process parameter and critical quality attribute data can be collected in real-time during the manufacturing process,” he states. “When critical steps are performed during manufacturing, teams have results before the process step or even the batch is complete, ultimately moving them to more efficient real-time control and closer to real-time release.”

“PAT and an emphasis on process understanding have been embraced by the majority of pharmaceutical manufacturers, and there are several case studies where both artificial intelligence (AI) and machine learning (ML) have led to improved quality or increased yield, even in good manufacturing practice (GMP) facilities,” adds Byrd. However, there are still regulatory hurdles impeding adoption of more modern techniques, she asserts. “[Although] this [situation] has improved over the past several years with the incorporation of engagement possibilities like the Emerging Technologies Team at FDA and the Innovation Task Force at EMA [European Medicines Agency],” Byrd notes.

In concurrence, Schmidt also emphasizes the importance online and at-line analysis has become in recent years. “Our customers want results much closer to product manufacturing and not always in the traditional lab,” he remarks.

Ensuring all equipment is running efficiently and effectively is another pertinent area to balance, according to Pettus. “By monitoring key characteristics of the equipment and the process, potential problems are identified, and appropriate actions can be planned to ensure emerging potential issues are resolved before they cause production problems,” he says. “And with regards to that planning, real-time scheduling software helps manufacturing and support teams to not only make the most of equipment time and production availability, but to also automatically reorganize schedules when there is an aberration—such as a supply chain issue, equipment failure, or other delays—to help ensure on-time production for improved delivery times and profitability.”

“Business continuity is key to any reliable supply chain, which includes ensuring all of a company’s facilities and equipment are available and operate as intended, to meet the flexible demands,” emphasizes Crincoli. In addition, it is just as important for manufacturers to build and select a strong, high quality, supplier base for raw materials and consumables, he adds.

Improvements in manufacturing efficiency can be made through comprehensive quality management systems that focus on digitization, reduce human errors, and improve data integrity, notes Krishnan. “These steps are backed up by having an operational excellence strategy, and a continuous improvement system, but whatever systems are in place, the most important step is a continuous investment in people, and the training of employees,” he says.

Pettus also highlights process and knowledge management software, which collates, contextualizes, and standardizes process steps and critical data across the entire lifecycle, as a useful tool for ensuring manufacturing efficiency from process development to full-scale manufacturing. “Ultimately, these are the technologies that will unlock one-click technology transfer in the future, which will be a key component of faster product launches, including individualized treatment,” he adds.

“Time can be saved using modular facilities and equipment that can be assembled offsite, and rapidly deployed,” continues Crincoli. “There is more equipment available with the ability to manufacture multiple forms (i.e., vials or syringes) on the same line, and employing single-use equipment can reduce cycle times while improving the overall speed of manufacturing campaigns. Time can also be saved, for example, when expediting a commercial launch, using strategies such as scaling out rather than scaling up, and again, utilizing continuous manufacturing where it offers an advantage.”

The importance of continuous manufacturing is growing, affirms Pettus, who agrees that it can help eliminate the scale-up issues that were common with the “one-size-fits-all” product development and commercialization process. “Instead of scaling up, continuous manufacturing capacity is increased by scaling out,” he states. “Organizations can use the same continuous manufacturing technology in their product development, clinical trial manufacturing, and commercial manufacturing. As demand increases, they can simply copy the technologies to new manufacturing facilities to increase output or bring manufacturing closer to a population in need, without the additional burdens of scaleup design and its associated technology transfer complications.”

Gupta is also in agreement about the exponential growth of continuous manufacturing and adds that further balance within bio/pharmaceutical manufacturing is being found in terms of opportunities as well. “Customers today are demanding higher quality at a lower cost,” he says. “Therefore, the playing field has levelled for manufacturers, offering scope and opportunity for new players from emerging markets.”

For emerging therapies, such as cell and gene therapies, more work is needed to balance the complexity of processes required to ensure the risk of errors is minimized, Pettus stresses. “Organizations need to find ways to improve the complicated technology transfer process, which is full of opportunities for errors,” he says. “A decentralized manufacturing model will be important for individualized therapies because they will need to be consistently manufactured closer to the patients, all over the world.”

Although, Deuber reveals that despite initial tools being derived from academia and ultimately not suitable for scale-up purposes, within the past five years much work has already been done by industry leaders in the design of advanced instruments to enable drug developers to improve the quality and manufacturability of innovative new medicines, such as cell and gene therapies. “There have been improvements throughout drug development, from molecule screening to purification,” he says. “For viral vectors in particular, suspension platforms have gradually replaced adherent processes to ensure scalability as the cell and gene therapy space expands to include further indications.”

Finally, Byrd iterates the importance of viewing equipment, software, and technology suppliers as valuable resources throughout the value chain, thanks to the expertise they can provide to guide risk assessments and selections of technologies on what is fit -for-purpose. “Vendors often engage with regulators to help them understand the underlying mechanisms in the products they provide and therefore assist industry to gain acceptance for deploying more modern manufacturing approaches that maximize the quality and efficiency of manufacturing processes and reduce costs,” she asserts.

“In an industry that is justifiably risk averse, change needs to be balanced with assuredness,” concludes UpDyke. “As new initiatives come along, there is a lot of work done to understand regulatory, quality, and reliability impacts. A lot of peer review and collaboration, such as the work done through BioPhorum [a global collaboration of industry leaders and subject matter experts], helps to ensure that new solutions are fully vetted and understood.”

Pharmaceutical Manufacturing: Trends Shaping the Future

. Industry Report, March 2022.
2. Mordor Intelligence. 

Pharmaceutical Manufacturing Market—Growth, Trends, COVID-19 Impact, and Forecasts (2023–2028)


Vol. 47, No. 4
April 2023
Pages: 16–20

When referring to this article, please cite it as Thomas, F. Balancing Change and Certainty in Manufacturing. 

As new manufacturing processes and technologies are introduced to meet demand and overcome challenges, understanding also needs to improve to ensure the right balance is achieved.  