Author Archives: Brian Gazaille

Surveying the Biosimilars Regulatory Landscape

BPI’s history coincides with that of biosimilars development. Although nonpeptide biosimilar products did not begin receiving commercial authorization until the 2010s, health authorities and drug makers already had been exploring the complex concept of biosimilarity. In the May issue of BPI’s first volume, Theresa L. Gerrard (then an independent consultant who also had been director of the Division of Cytokine Biology at the US Food and Drug Administration Center for Biologics Evaluation and Research, FDA CBER) wrote: The potential for…

eBook: Factors Affecting Scalability of Cell Therapies

The number of cell and gene therapies in different phases of development is increasing. The industry currently needs to increase commercial good manufacturing practice (GMP) capacity to keep up with current and future demands. Cell and gene therapy scale-up from clinical to commercial capacity levels can reduce cost of goods and thus price per dose.  An optimized bioprocess facilitates scale-up from hundreds (clinical scale) to thousands of doses (commercial scale). Different approaches for increasing scale can be taken. For example,…

Flexible Vaccine Manufacturing: Collaborations Bringing Localized Solutions

The COVID-19 pandemic has become the most recent reminder of how accessibility to drugs and vaccines depends heavily on geographical location and a country’s economic health. Some countries continue to lack the infrastructure, regulatory support, and trained workforce necessary for establishing a viable bioindustry. Unizima, part of the Univercells Group, is a team of experts, scientists, and engineers that partners with public and private companies and other organizations to help build biomanufacturing capabilities in low- and middle-income countries (LMICs). We…

Developing Subunit Vaccines Based on an Amphiphile Platform

Subunit vaccines stimulate immune cells by delivering selected components of a pathogen of interest rather than the entire pathogen. Elicio Therapeutics is developing subunit vaccines that target a recipient’s lymph node to elicit a robust immune response. The vaccines are based on the company’s amphiphile (AMP) platform (Figure 1). The platform-based drug candidates are targeting cancer and COVID-19. Their development would allow the vaccine to be stored without the need for ultracold and cold storage. Below, we discuss the development…

Development of Allergen Immunotherapies

Desentum, a biopharmaceutical company that specializes in developing allergen immunotherapy (AIT) products, has partnered with contract development and manufacturing organization (CDMO) Biovian to advance hypoallergens based on targeted modifications to recombinant proteins. I spoke with Kati Sallinen (director of strategy and communications at Desentum) and Jonne Vaarno (project manager at Biovian) about their companies’ development of AITs and a potential platform to treat different types of allergies. Our Discussion We all know someone with an allergy, and many people have…

Managing Manufacturing Requirements for Live Biotherapeutics

In 2018, Synlogic explored options for producing clinical-trial material for its lead programs, including a candidate therapy for the rare metabolic disease phenylketonuria (PKU). Like other emerging drug developers, the company evaluated the merits of outsourcing manufacturing to third parties. However, Synlogic leverages synthetic biology tools to design and develop therapeutics based on genetically engineered microbes. Thus, it also needed to consider requirements specific to live biotherapeutics. Late in 2018, Synlogic announced plans to establish its own current good manufacturing…

Ask the Expert: Analytical Tools to Accelerate Cell-Line Development Workflows

Cell-line development (CLD) involves screening thousands of clones to identify the most stable and productive candidate for an upstream manufacturing process (Figure 1). Such assessment requires considerable time and resources for preparation and execution of multiple cultivations and analytical assays. In March 2022, Lukas Klein and Dirk Müller (scientist and manager of media and process development, respectively, at Sartorius) delivered a BPI Ask the Expert webinar about integrating their company’s Ambr 15 Cell Culture bioreactor and Octet label-free biolayer interferometry…

Managing Host-Cell Proteins: Robust Risk-Assessment Frameworks for Process-Related Impurities in Biological Products

Although biomanufacturing processes are designed to generate highly pure drug substances, some host-cell proteins (HCPs) copurify with target proteins and thus remain in finished drug products. Biopharmaceutical developers are keenly aware that such impurities must be minimized to protect patients. HCPs can activate several kinds of immune responses in treated patients, including production of antidrug antibodies and induction of cross-reactivity with therapeutic proteins (1–5). HCPs also can diminish drug efficacy, potency, and/or stability (6, 7). Thus, regulatory guidances such as…

eBook: Potency Bioassays — Development, Trending, Transfer, and Automation

Bioassay development is a complex process that must be undertaken with great rigor and attention to detail. Potency testing experts use a range of methods including cell-based and binding assays. Consistency and reliability of results over time are paramount. Well-developed and -characterized methods are the end result of much phase-appropriate development work that goes on in parallel with bioprocess and biotherapeutic product development. This eBook begins with BPI senior technical editor Cheryl Scott’s report from the Biopharmaceutical Emerging Best Practices…

Navigating New Options for Commercial-Scale Biopharmaceutical Production

Scalability remains a critically important topic for biopharmaceutical companies. For conventional protein products, the strategy once was straightforward: Drug makers would scale up, beginning with cultures in flasks and roller bottles to grow enough cells to inoculate laboratory-scale (often glass) bioreactors, then again to pilot- and commercial-scale, stainless-steel, stirred-tank bioreactors. At their highest volumes, such reactors can handle tens of thousands of liters of cells and growth media. If a drug developer did not have the requisite equipment to scale…