2020

Using Blockchain Technology to Ensure Data Integrity: Applying Hyperledger Fabric to Biomanufacturing

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Digitalization of manufacturing operations is a major challenge that many industries face. With the advent of smart equipment, automation of unit operations and complete processes, and digitalization of batch documentation, more data are generated now than ever before. The information must remain manageable, and data integrity needs to be ensured. The challenge for biomanufacturers will be to ensure that their entire large output of data will be attributable, legible, contemporaneous, original, and accurate (ALCOA) as defined by the US Food…

March 3, 2020

A Response Plan for Viral Contamination in Bioproduction Facilities

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The biopharmaceutical industry uses living biological systems as a platform for manufacturing of protein-based drugs, vaccines, and other therapies derived from or consisting of different cell types. On one hand, living systems are inherently susceptible to viral infection and may harbor endogenous viruses, so the potential for such contamination cannot be eliminated. On the other hand, the industry has an excellent patient-safety record. Viral safety is achieved through three fundamental measures: prevention (e.g., by selection), removal (by clearance and/or reduction),…

March 3, 2020

Implementation of Single-Use Miniature Bioreactors to Support Intensified Cell Culture: Using Functional Performance Indicators to Assess a Small‑Scale Model

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Changes to bioprocessing in the biopharmaceutical industry are driven by the need for increased speed, lower cost of goods (CoG), and greater flexibility (1). To meet these challenges, the industry is adopting strategies that include intensified processing. During the initial stages of intensified processing, it is essential to identify the most productive and/or stable clones for use before starting pilot-scale studies. That requires screening large numbers of clones and then further testing the most promising ones in benchtop bioreactors. The…

March 3, 2020

Ask the Expert: Accelerating Development and Manufacturing Platforms for Viral Vectors

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Bai-wei Gu, Juan Lagos, and Matthew Weaver (heads of cell line development, upstream process development, and downstream process development groups, respectively, at WuXi Advanced Therapies, ATU) joined forces on 29 October 2019 to feature their company’s viral-vector manufacturing capabilities for cell and gene therapies. In addition to adherent platforms for lentivirus (LV) and adenoassociated virus (AAV) vectors, ATU soon will offer suspension-cultured viral vector platforms for them as well as analytical measures that support release testing. Transitioning from adherent to…

March 3, 2020

Ask the Expert: Best Practices for Aseptic Sampling from Stainless-Steel Equipment

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Turn-key single-use aseptic sampling devices (ASDs) have diminished bioprocess contamination risks significantly. But depending on testing, facility, and storage needs, some ASD container types are more effective than others are. Bobbi Allen (technology expert at Sartorius Stedim Biotech North America, SSB) focused her 8 January 2020 “Ask the Expert†presentation on “what, why, when, and where†operators must sample aseptically from stainless-steel tanks. Using data from in-house testing of aseptic sampling containers, Allen offered key considerations for sterility, process monitoring,…

March 3, 2020

Better Bioprinting Ahead: Breakthroughs and Remaining Challenges

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Bioprinted organs soon could revolutionize clinical trials, transplantation, and regenerative medicine. But as Chris Lo reminds us in a new GlobalData report (1), several technical hurdles must be negotiated before biopharmaceutical companies can harness three-dimensional (3D) bioprinting for such purposes. BPI explores persistent printing problems and promising solutions below by analyzing Lo’s report alongside commentary from founding editorial advisory board member Bill Whitford (bioprocess strategic solutions leader at GE Healthcare Life Sciences), Lev Gerlovin (vice president in the life sciences…

March 3, 2020

Improving Bioprocess Expression Systems: A Clean Alternative to CRISPR/Cas9

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Chinese hamster ovary (CHO) cells have emerged as a robust platform for bioprocessing serving both early and late-stage biotherapeutic drug supply. However, these cells and other hosts (e.g., HEK293), can be optimized for even greater potential through advanced gene editing. For example, when the endogenous glutamine synthetase (GS) gene is knocked out in CHO cells, a sixfold increase in high-producing cell lines is achieved (1). In another study, CHO with annexin A2 (ANXA2) and cathepsin gene (CTSD) knockouts were introduced…

February 27, 2020

eBook: Sensor Technologies — Essential Tools for Bioprocessing 4.0

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Sensors are essential devices that can be used for most, if not all, typical biopharmaceutical development and manufacturing processes to monitor fundamental process parameters such as flow, temperature, pH, and dissolved oxygen throughout all process stages. As the bioindustry progresses toward automation, digitalization, and other “Manufacturing 4.0” concepts, robust single-use and smart sensors for bioprocess monitoring will be needed. Read this BPI eBook to garner valuable perspectives on both of these types of sensors. Discussions herein focus on smart sensor…

February 27, 2020

eBook: Peptide Therapies — Small Biomolecules Address Big Health Problems

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This crash course in the development of peptide therapies brings together two articles: one on product research and the other on manufacturing and regulatory concerns. In “Fighting Alzheimer’s Disease from Within: A Breakthrough Peptide,†freelance journalist Marc Davis highlights current developments in Alzheimer’s disease treatment, focusing specifically on a peptide approach from Canadian company NervGen. In “Making Peptides Work,†BPI’s senior technical editor adds perspective on developing and manufacturing peptide therapies from the Informa Connect community, with commentary from experts…

February 25, 2020

eBook: Continuous Bioprocessing — Promises and Challenges

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Biotechnological productions are commonly executed as batch processes, especially during downstream processing. Higher titers in fermentations, reductions in operating scale, and the quest for improving product quality all have led to an intensified effort for developing continuous processing. It is forecasted that within the next 10 years, about 50% of all drugs under development will be biopharmaceuticals, making it worthwhile to develop more efficient processes. In this BPI eBook, Babu Halan (project engineer) and Wolfgang Minas (global lead of the…

February 18, 2020