March 2021

March 2021: From the Editor

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In my short time as BPI’s resident novice, I have been impressed with this industry’s interdisciplinarity and collaborative spirit. Executives tell me that biopharmaceutical companies have not always been so multifaceted in their expertise or so willing to forge partnerships across organizations and over the industry–academia divide. I am lucky to have started working with you when I did late in 2019. That is not to regard the biopharmaceutical industry with rose-tinted glasses. Many elements of biomanufacturing remain closely guarded…

March 9, 2021

Embracing Innovation in Biomanufacturing

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Innovations in bioproduction of therapeutics over the past 20 years have led to impressive improvements in product yield, process controls, and manufacturing safety. Industry 4.0 concepts have been embraced across the bioprocess industry and are leading to better bioprocess control through process automation, “big data†and data analysis, process simulations, the industrial internet of things (IIoT), cybersecurity, the cloud, blockchain/serialization, and additive manufacturing. Such advances help to ensure that a process results in the same outcome every time. As Sean…

March 9, 2021

The EU MDR Deadline Delay: What Does It Entail for Pharmaceutical Companies?

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The life-sciences industry has been working hard to meet the deadline for compliance with the European Union’s Medical Device Regulation (EU MDR, 2017/745) (1). Doing so has been a challenging journey for many companies. Therefore, the full-year postponement of the final application date has been a welcome development, particularly in view of the new and extraordinary challenges stemming from the COVID-19 global health crisis. The extension has instigated other important changes, so it is critical that life-science businesses familiarize themselves…

March 9, 2021

Emerging Strategies for Drug Product Comparability and Process Validation: Part 1 — Analytical Tools and Drug Product Comparability

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Process validation is a key part of the development and manufacture of all approved drug products, but its completion can be a daunting task. At a two-day CASSS CMC Strategy Forum held in July 2016 in Gaithersburg, MD, speakers and attendees addressed the many technical, practical, and regulatory facets of drug product process validation and comparability. In part 1 of this report, we summarize the key discussion points of the first day, which focused on analytics and comparability. Session One:…

March 9, 2021

Customized Yeast HCP Quantification with Biolayer Interferometry Using a Horseradish Peroxidase Substrate

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Biopharmaceuticals are the largest group of drugs under development (1), and the demand for new and safe drug products is high. The most common bacterial and mammalian cell lines for production are Escherichia coli, Chinese hamster ovary (CHO) cells, and yeast. During a production bioprocess, a cell line expresses not only the molecule of interest, but also host-cell proteins (HCPs). They are considered to be impurities in a final drug product because they can affect the efficacy and safety of…

March 9, 2021

Compounded Media Powder Streamlines Cell Culture Media Preparation Operations

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Cell culture medium is critical to cell growth, metabolism, and protein expression. It provides for optimum pH, osmolality, and nutrients in an environment that is essential for cell survival, growth, and expression of proteins and/or metabolites and drug-substance modalities of interest (1). A complete medium typically contains basic nutrients such as carbohydrates, amino acids, lipids, salts, vitamins, trace metals, growth factors/hormones (e.g., insulin), antishear factors, and other chemicals that facilitate cell growth and protein expression and may stabilize recombinant protein…

March 9, 2021

Improving Cell Manufacturing Outcomes Using In-Line Biomarker Monitoring

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Cell-based advanced therapies are changing modern medicine dramatically. Immunotherapies such as chimeric antigen receptor (CAR) T-cell therapies are treating different forms of cancer. Gene therapies are reversing the course of inherited diseases, and tissue-engineered medical products are restoring, maintaining, and replacing damaged organs (1–4). The development of new advanced therapies is booming. As of January 2020, the US Food and Drug Administration (FDA) has reported more than 900 investigational new drug (IND) applications for cell and gene therapy products. However,…

March 9, 2021

Using Prior Knowledge to Estimate Long-Term Variation

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A reasonable estimate of long-term variation for a biopharmaceutical product critical quality attribute (CQA) can be challenging to justify, especially in the early stages of a product’s lifecycle when only limited data are available. However, if the combination of product and analytical method reasonably can be matched with historical data, prior knowledge can provide an estimate of a value. This variation estimate could be used to assist in risk assessments related to continued process verification (CPV) activities, including control charting…

March 9, 2021

Ask the Expert: FPLC Column Selection Considerations

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On 10 November 2020, BPI presented an “Ask the Expert†webinar with Dan Yukon (head of North American and global SNAP product sales at Astrea Bioseparations) on considerations for selecting analytical fast-protein liquid chromatography (FPLC) columns. With many options on the market, deciding which type and brand to use can be difficult. To help take out the guesswork, Yukon addressed a number of topics, including pressure and volume considerations; column configuration; materials of construction; frit type, design porosity, and mounting;…

March 9, 2021

Ask the Expert: Centrifugation Guided By Optical Sensors Enables Efficient, Reagent-Free Cell Separation

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Ben Josey, PhD (field application scientist at Corning Life Sciences), joined BPI on 3 December 2020 to deliver an “Ask the Expert†presentation about using optical-sensor–guided centrifugation for cell therapy development. Cell-separation techniques fall into four basic categories: filtration, centrifugation, affinity purification, and emerging methods such as microfluidics and acoustofluidics. Selecting the technology best suited to an application requires careful balancing of method precision and process efficiency, the latter of which includes factors such as batch size, time, labor, and…

March 9, 2021