Friday, April 16, 2021 Daily Archives

Trade-Secret Vulnerabilities: Recent Hacking Schemes Highlight the Need to Protect Proprietary Pharmaceutical Information

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On 21 July 2020, the US Attorney’s Office in Spokane, WA, unveiled a sweeping indictment accusing a pair of Chinese hackers of conspiring to steal trade secrets from a number of American pharmaceutical companies and research institutions, including biotechnology companies working on potential COVID-19 vaccines (1). Although the hackers apparently did not succeed in their attempt to obtain vaccine data, their years-long conspiracy involved other attacks on the pharmaceutical industry — and netted them troves of sensitive commercial information. Among…

April 16, 2021

Biomanufacturing Workforce Development: Fostering Talent During and After the Pandemic

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Beyond the human suffering and economic damage caused by COVID-19, one of the most powerful results of the pandemic has been to focus global attention on drug and vaccine development for infectious diseases. Massive investments by governments, institutions, and biopharmaceutical companies have accelerated development of novel therapeutics, including messenger RNA (mRNA) and viral-vector vaccines, that are poised to become transformational platform technologies for biopharmaceutical manufacturing (1). Furthermore, the well-established technology of monoclonal antibodies (MAbs) has lived up to its promise…

April 16, 2021

Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management

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This two-day CASSS CMC Strategy Forum explored many technical, practical, and regulatory facets of biological drug-product (DP) analytics, process validation, and comparability. Part 1 of this report summarized the discussions on drug-product analytics and comparability in BPI’s March 2021 issue (1). Here we report on day two presentations and discussions on validation, legacy products, and lifecycle management. Session Three: Drug-Product Validation The morning session focused on principles of process validation with examples of challenges specific to drug products. New Risk-Based…

April 16, 2021

Virus Assay Variation Is the Main Source of Variation in Viral Clearance Studies: Retrospective Analysis of a Large Data Set

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Biopharmaceuticals produced from mammalian cell cultures are susceptible to viral contamination. That risk is mitigated by applying complementary approaches. Those include extensive testing of cell banks, selecting low-risk raw materials, testing cultivations for viruses, and documenting the capacity of a purification process to inactivate and remove viral contaminants. The latter commonly is referred to as viral clearance and usually expressed as a log reduction value (LRV). Novo Nordisk has performed several viral clearance studies for different processes and process steps.…

April 16, 2021

SARS-CoV-2 Hyper-Immunoglobulin: Purification and Characterization from Human Convalescent Plasma

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The novel severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) emerged as a major pandemic coronavirus disease in 2019 (COVID-19) and since then has killed many people and paralyzed the global economy (1, 2). With specific antiviral therapeutic agents or antibodies yet to be approved, other antivirals and novel vaccine strategies have been essential to containing the virus and disease transmission. Passive antibody therapy can be used to limit the scope of epidemics by providing patients with antibodies that recognize…

April 16, 2021

Viral Clearance in a Downstream AAV Process: Case Study Using a Model Virus Panel and a Noninfectious Surrogate

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Over the past decade, adenoassociated virus (AAV) vectors have become established as leading gene-delivery vehicles. In 2017, the pipeline for gene therapies included 351 drugs in clinical trials and 316 in preclinical development (1–4). As those candidates advance, significant efforts are being made in process development and manufacturing for viral vectors, with the overall goal of reducing process impurities while maintaining the highest possible process yield. To address that goal, industry suppliers have developed innovative AAV-specific separation technologies. Thermo Fisher…

April 16, 2021

Rapid Development of Viral Vector Production Processes: Iterative Parameter Optimization

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With recent developments and successes in cell and gene therapy, the biopharmaceutical industry is facing increased demand for safe and efficient delivery systems (1). Viral vectors, including adenoviruses (AV), adenoassociated viruses (AAV), and lentiviruses (LV), are among the most common delivery agents because they infect mammalian cells efficiently. Suspension cultures have become a popular choice for robust and scalable viral manufacturing systems. Using stable cell lines that integrate all or part of the viral production elements adds further benefits by…

April 16, 2021

Ask the Expert: High-Yield mRNA Processing — From Plasmid to Highly Purified Product

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Interest in industrial-scale production of messenger RNA (mRNA) has surged amid rapid development of mRNA-based vaccines against SARS-CoV-2. During an 18 February 2021 Ask the Expert presentation, AleÅ¡ Å trancar (chief executive officer of BIA Separations, a Sartorius company) reminded attendees that no platform approach yet exists for mRNA production and that much remains to be learned about manufacturing such products at commercial scales. He described current production challenges and shared BIA’s efforts to devise flexible mRNA purification tools. Å trancar’s Presentation…

April 16, 2021

Ask the Expert: Leveraging Cloud Capabilities to Execute CHO Cell Culture Experiments

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Process development teams have relied for decades on benchtop bioreactors to perform mammalian-cell–culture experiments; however, doing so requires significant resources and staffing. During a 24 February 2021 presentation, Deborah Pascoe, PhD, vice president of operations at Culture Biosciences (Culture), explained how to leverage her company’s high-throughput, cloud-connected bioreactors to execute Chinese hamster ovary (CHO) cell cultures with high reproducibility and scalability. Pascoe’s Presentation Pascoe described her company as an extension of a customer’s laboratory. After technology transfer, Culture and a…

April 16, 2021

Defining a Successful Biotechnology Entrepreneur

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Having brought its first vaccine candidates from concept to clinical development in less than three months, BioNTech is making global waves as the pioneer behind Pfizer’s COVID-19 vaccine. Because of such success stories, more eyes than ever are looking at opportunities raised by the biotechnology industry. As talented people around the world from academia, clinical practice, and other industries consider careers in this sector, they should examine the characteristics necessary to become successful biotechnology entrepreneurs. Biotechnology fuses science and business.…

April 16, 2021