January-February 2023

January-February 2023: From the Editor

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The “happy new year” routines are pretty much over with by now, with their many variations on “shhh, don’t scare the new year away” and “2023 has got to be an improvement” among other expressions of “good riddance to 2022” and our collective anxiety over ongoing global crises. Meanwhile, as it has done since its inception, the biopharmaceutical industry continues adapting to survive and thrive as it celebrates considerable milestones. BPI devoted much of 2022 to retrospective analyses of progress…

February 9, 2023

The Talent Enigma in Digital Biomanufacturing

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Demand for talent in the biopharmaceutical industry already had been climbing before the COVID-19 pandemic, showing an increase of 26% from 2018 to 2020. By the end of 2021, a further 32% surge was observed in the United States and Europe, against a 10% rise in the supply of expertise. Bolstered at first by the need to manufacture SARS-CoV-2 vaccines and therapeutics and now by the threat of new pandemics, current market drivers include increases in investment, initial public offerings…

February 9, 2023

Delivering the Digital Skills Needs of the Bioprocessing Sector: Realizing the Vision of Industry 4.0 for Your Organization

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As the bioprocessing sector marches toward the future, digitalization stands at the heart of the Industry 4.0 vision of smart, self-organizing factories. Along with critical success factors such as infrastructure investment in cloud-based technologies, digitalization enables companies to turn data into intelligence. The realization of Industry 4.0 promises digitally integrated facilities with fully automated manufacturing, real-time traceability, standardized procedures, and agile processes (1, 2). Here, we present the results of a benchmarking survey that drew participation from leading biopharmaceutical companies.…

February 9, 2023

Overcoming AAV Manufacturing Challenges: Movement Toward Plug-and-Play Solutions

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Discovered in the mid-1960s, adenoassociated viruses (AAVs) have become the leading vector for gene therapy in recent years. In October 2012, the first European market authorization for a human gene-therapy product was granted for UniQure’s Glybera (alipogene tiparvovec), which contains an AAV1 vector for treating patients who have lipoprotein lipase deficiency. (The product has been withdrawn from the market because of limited demand.) Both gene therapies currently approved in the United States — Luxturna (voretigene neparvovec) from Spark Therapeutics, approved…

February 9, 2023

Opportunities in the Field of Host Cell Proteins — Part 4: The Future of Immunogenicity Prediction

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Available literature abounds with case studies describing detection and identification of host cell proteins (HCPs) and other process-related impurities. In the previous installment of our review, we analyzed noteworthy studies, highlighting what they revealed about HCP immunogenicity and calling attention to topics that require further investigation. In this final installment of our four-part study, we focus on HCP risk assessment. We explore current and emerging strategies for immunogenicity prediction, then draw out key insights from the past 40 years of…

February 9, 2023

Shear-Proof Design Space: Scaling Stirred-Tank Bioreactors for Cell Culture Processes

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Establishing a cell culture process across different scales and models of bioreactors involves maintaining constant scale-independent parameters such as pH, temperature, and dissolved oxygen (DO). However, nonlinear and scale-dependent criteria (impeller agitation and gas flow rates) are adjusted on the basis of multiple normalized engineering parameters to accommodate the geometrical and design differences among bioreactors (1–3). Normalized engineering approaches for scaling parameterization often are based on the shear generated by impeller speed and gas flow rates. Kinetic energy transmitted into…

February 9, 2023

Real-Time, Data-Driven, and Predictive Modeling: Accelerating Digital Transformation in Drug Substance Commercial Manufacturing

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Biopharmaceutical drug-substance (DS) manufacturing consists of several unit operations. Upstream production includes multiple steps in growing bacterial or mammalian cells in culture. Upstream activities are followed by a series of downstream processing units including chromatography and filtration steps for removing impurities and purifying a therapeutic molecule (1). All these operations are inherently complex because of the natural variability associated with growing living cells and the intricacy of purification techniques used for collecting biological products. The US Food and Drug Administration…

February 9, 2023

Save Valuable Facility Time with Single-Use TFF

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Biopharmaceutical developers and manufacturers are part of a global, dynamic, and highly competitive market. They face constant pressure to produce high-quality products within relatively short time frames and at reduced costs. Process-intensification strategies and single-use (SU) solutions are popular approaches to maximizing productivity and promoting fast, efficient, and lean processing — the pillars of next-generation facilities. Filtration is an integral part of all bioprocesses and is applied to many up- and downstream steps, including harvest, clarification, and concentration/diafiltration. Tangential-flow filtration…

February 9, 2023

Less Is More in mRNA Therapeutics: Developing Big Ideas at Small Scales

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In a November 2022 webinar, Linda Mathiasson (strategic customer lead at Cytiva) discussed the significant promise of messenger ribonucleic acid (mRNA), its role in fighting genetic and infectious diseases, and how its production can be scaled to meet the needs of different applications, ranging from large-scale vaccination to production of individual therapies. The Presentation Thanks to the rapid development of mRNA vaccines for COVID-19, the biopharmaceutical industry has gained momentum toward realizing the technology’s potential. The speed, flexibility, and low-cost…

February 9, 2023

Grow Your CDMO with Automated Aseptic-Filling Workcells

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Contract development and manufacturing organizations (CDMOs) and biopharmaceutical companies are facing shortages in capacity for production of clinical trial material. Even as large-volume commercial biofilling capacity has increased significantly since the beginning of the pandemic, drug developers are forced to use inefficient and risky filling methods that leave them with unmet demand. John Harmer (Cytiva’s strategic initiatives leader for aseptic filling) addressed the need for flexibility and capacity for CDMOs and their clients by introducing two gloveless robotic isolator technology…

February 9, 2023