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

Total Global Capacity Finally Shows Improved Productivity

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Since 2018, global bioprocessing capacity has grown from 16.5 million liters (1) to 17.4 million liters. Although output has continued to expand at around 12% overall, that rate represents a significant slowing in capacity growth as the industry moves toward greater productivity and efficiency. Trends that we have tracked in the BioPlan Associates annual report of biopharmaceutical manufacturing capacity and production (2) for over 17 years correlate with that finding. Titers are increasing; single-use technologies have reduced the need for…

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

Expanding the Flow Cytometry Toolkit with Next-Generation Polymer Dyes

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Since the emergence of SARS-CoV-2, scientists have discovered more about the role of our immune systems and cytokine-associated processes responsible for systemic immune reactions that are typical in patients with COVID-19 (1). Flow cytometry is used to understand those processes at a single-cell level. It is the standard method used in immunology to characterize multiple phenotypic and functional parameters of single cells, including cytokine analysis. Despite advances in flow cytometry instrumentation, reagents, and analytical software, several challenges remain. Conjugated antibodies…

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

Ask the Expert: Formulation Strategies for AAV-Based Gene Therapies

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Although formulation and drug-product activities are critical to developing gene therapies, much remains to be learned about their degradation mechanisms, and firm criteria still need to be established for buffer and excipient selection. Sarathi Vijay Boddapati (associate director of formulation and drug development at Catalent Cell and Gene Therapy) joined BPI on 25 March 2021 to present what his company continues to learn about formulating gene therapies by adapting methods used for other biologics. Boddapati’s Presentation Adenoassociated virus (AAV) remains…

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