Manufacturing

Overcoming Obstacles in AAV Viral Vector Manufacturing

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Rapidly growing interest in gene therapy has led to the need for more cost-effective and scalable viral-vector manufacturing platforms. Adenoassociated virus (AAV) has become a vector of choice because of its safety profile (nonpathogenic infection). In addition, AAV cannot replicate on its own and is not integrated directly into the host genome. AAV vector manufacturing using human embryonic kidney (HEK) cells in either adherent or suspension mode includes several typical processing steps: cell expansion, plasmid transfection, viral-vector production, cell lysis,…

June 18, 2021

Eradicating the Need for Cold-Chain Distribution in the Biopharmaceutical Industry

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Cold chain distribution is complicated and critical for formulations that must be kept in very cold temperatures in the pharmaceutical industry, since their stability decreases quickly at room temperatures. The World Health Organization (WHO) has reported over 50% of vaccines are wasted and must be disposed of globally every year due in part to disruption of the cold chain distribution and lack the resources to support the ultracold temperature requirements. A possible solution to the existing problem is Hyalo Technologies’…

June 11, 2021

Single-Use Systems for Storing and Shipping Frozen Drug Materials

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Using presterilized, single-use freeze–thaw systems instead of traditional freeze–thaw platforms that include stainless-steel tanks and bottles can help biomanufacturers manage the quality of their drug substances. Single-use assemblies reduce the risk of cross-contamination, simplify dispensing, and decrease the number of manual interventions during freezing, thawing, handling, and shipping. However, implementing a freeze–thaw process requires careful testing of the physical and thermal properties of single-use systems and related aseptic connectors as well as assessment of drug-substance quality and stability. Such evaluation…

June 1, 2021

Risk Considerations for Aging Pharmaceutical Facility Cleanrooms

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Pharmaceutical facility cleanrooms are designed to reduce and control particle contamination and to minimize the ingress and retention of microorganisms. Such risks typically are easy to control in well-designed, modern facilities. But risk mitigation is more difficult in older facilities. There is no exact definition of what constitutes an aging facility (or what are sometimes euphemistically called legacy facilities). For example, a facility established 100 years ago to manufacture a simple tablet can continue to operate perfectly well with careful…

May 21, 2021

Facilities Roundup: What’s Behind the Expansions?

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In the early 2000s, the trade press was abuzz about an imminent “capacity crunch†in mammalian cell culture. Dire predictions of shortages were based on biopharmaceutical successes to that point, on bursting development pipelines, and on the lengthy timelines and high costs of assembling tens of thousands of liters of stainless-steel bioreactors and supporting infrastructure. Those predictions failed to anticipate several positive developments that would render doom-and-gloom scenarios moot. Notably, yearly improvements in protein titers for MAb processes already were…

May 21, 2021

Rapid Deployment of Manufacturing Options: An Analysis of Risks and Benefits

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Biomanufacturers seeking the best approach to rapid implementation of flexible manufacturing capacity take into account the benefits presented by different modular construction options. We analyzed different approaches to building manufacturing capacity and assessed the economic benefits of each approach. Our evaluation was based on biopharmaceutical products for which there is an immediate unmet need, such as treatments or vaccinations for COVID-19. Such products also might entail a sudden increase in demand (e.g., expansion of a product indication or sales ramp…

May 21, 2021

Facilities for Novel Therapies: Demystifying Design and Engineering Requirements for Cell and Gene Therapy Production

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Many veterans of the biologics industry presume that emerging therapeutics such as cell and gene therapies (CGTs) require production facilities that differ substantially from those for monoclonal antibodies (MAbs) and other conventional biologics. But experience with designing CGT facilities bears out that far more synergies than differences exist across facilities for conventional and advanced therapies. Herein, I call attention to some of those shared design concerns and demystify facilities and engineering requirements for CGTs. Observing the Synergies Many processes have…

May 21, 2021

Benefits of Single-Use Standardization: Adopting a Standard Design Approach

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It is widely accepted that standardization of single-use designs and assemblies would be beneficial to the biopharmaceutical industry, providing it quickly with simple and economical solutions. Meanwhile, as implementation of single-use technology increases across the biopharmaceutical industry, suppliers are struggling to keep up with demand. That has been evident particularly in current supply issues caused by the COVID-19 pandemic. A widely adopted single-use standardization approach could help alleviate such supply issues. That would not only benefit the industry by helping…

May 21, 2021

Facility Design:
A Guide to Maximizing Value

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Rapid growth and changing market dynamics in biologics and vaccine sectors have prompted biopharmaceutical companies and contract development and manufacturing organizations (CDMOs) to build new manufacturing facilities at unprecedented speeds. This often means developing single-use (SU) or hybrid bioprocessing facilities with reusable legacy equipment for production of monoclonal antibodies (MAbs), antibody–drug conjugates (ADCs), and viral-based vectors. For many companies, facility design begins by engaging an engineering consultancy to develop a layout that maximizes space use and minimizes equipment, fittings, and…

May 21, 2021

The Pandemic Changes Facility Strategy: A Focus on Speed to Market Triggers Innovation

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The push to expedite COVID-19 vaccines over the past year has led the biopharmaceutical industry to try novel strategies to accelerate product development and manufacturing. To compress discovery, development, and manufacturing into several months rather than a typical multiple-year effort has meant reexamining nearly every aspect of the process — including facilities required to house the work. Successful COVID-19 vaccine development undoubtedly will change biomanufacturing strategy forever. Previously, current good manufacturing practice (CGMP) manufacturing options were twofold: building facilities and…

May 21, 2021