2021

Ask the Expert: Streamlining Mesenchymal Stem Cell Production — From Expansion Through Removal of Cryoprotectant

The number of cell therapy product candidates based on mesenchymal stem cells (MSCs) has grown steadily since their clinical debut in 1995. As of June 2020, clinical investigators were evaluating more than 1,100 such therapies. Scaling up MSC production remains challenging, however. On 31 May 2021, Hilary Sherman (senior scientist at Corning Life Sciences) presented an “Ask the Expert” webinar describing her company’s efforts to facilitate MSC workflows. Sherman’s Presentation Easing Expansion: MSCs have strong differentiation capability and can be…

Ask the Expert: A Novel Escherichia coli System for Controlled Release of Difficult-to-Secrete Proteins

Although Escherichia coli often enables dependable, highly productive expression of nonglycosylated recombinant proteins, the efficiency with which it secretes a target protein into culture supernatant can depend greatly on that molecule’s physicochemical properties. Some proteins remain trapped in periplasm, thus diminishing process yield and productivity. In June 2021, Marcel Thoen (head of Wacker Biotech’s Global Competence Center for Cell Line Development) described how his company’s improved ESETEC (E. coli secretion technology) solutions can address productivity challenges raised by difficult-to-secrete recombinant…

Ask the Expert: Critical Steps in Potency Assay Development

Biologics undergo extensive characterization to demonstrate their safety, purity, and efficacy. Jennifer Lawson (product manager for cell line, media, and testing solutions at Sartorius) highlighted the role of potency assays in that process. Because they reflect the complexity of biological systems, scientists must develop robust assays that will provide sufficient data for good-practice (GxP) applications. Lawson pointed out milestones in the bioassay life cycle and explored ways to help ensure method suitability. Lawson’s Presentation Development Criteria: Potency assay development requires…

Ask the Expert: HCP Analysis By Orthogonal Methods in Vaccine and Gene Therapy Development

Regulators require testing of drug products for process-related impurities throughout development to monitor product safety, purity, and efficacy. Low levels of most impurities can be inconsequential, but patient safety demands that host-cell proteins (HCPs) be eliminated or reduced to the lowest levels practical. Enzyme-linked immunosorbent assays (ELISAs) represent a key tool in that endeavor. Antibody-coverage analysis is one part of assessing a platform kit or custom HCP ELISA. In a 15 June 2021 webinar, Jared Isaac (senior scientist at Cygnus…

The Next COVID Challenge: Building an Arsenal of Vaccines

For months, international partners have pressured the United States about intellectual property (IP) concerns and access to SARS-CoV-2 vaccines. As the country emerges from the worst of the pandemic, President Joe Biden now has an opportunity to shift his administration’s focus to realizing its longstanding promise of making the United States “the arsenal of vaccines for the world” (1). However, the country cannot accomplish that goal just by exporting mRNA vaccines and waiving IP protections. The current generation of vaccines…

eBook: Bispecific Antibodies — Their Development and Manufacture As Therapeutics

Generating antibodies with two or more specificities is one of the most innovative fields in therapeutic antibody development, with tremendous potential for use in creating new treatments for patients with unmet medical needs. In particular, bispecific antibody development is stimulating innovations in bioprocessing techniques from expression through upstream processing and candidate purification. Wherever possible, process-development scientists and engineers are borrowing techniques that were honed for mature monoclonal antibody (MAb) platforms, then applying those to bispecific antibody manufacturing. Nevertheless, the unique…

Kuhner TOM For Off-Gas Analysis in Shake Flasks

To facilitate and speed up process- and media development, online measurement techniques for shake flasks accompany manual sampling for maximum information output per cultivation. Off-gas analysis gives oxygen transfer rate (OTR), carbon dioxide transfer rate (CTR) and respiratory quotient (RQ) as quantitative measures of the physiological state of the culture. On shake flask scale, multiple cultivations are usually run in parallel. Off-gas analysis should therefore be cost effective, easy to handle and versatile to match various applications. Therefore, we developed…

Ask the Expert: Leveraging Quality Management Systems to Achieve Competitive Advantages

During a May 2021 “Ask the Expert” presentation, Jigisha Patel (vice president of global regulatory compliance and technical services at Spectrum Chemical Manufacturing Corporation) emphasized the need to minimize supply-chain contingencies that lead to variability across raw materials used in biopharmaceutical manufacturing. Deviations in raw-material specifications can jeopardize good manufacturing practice (GMP) compliance and reduce drug-product efficacy and stability. Patel explained how her company’s quality management system ensures that bioprocess materials will meet specifications and process needs. Patel’s Presentation Patel…

Tools to Support COVID-19 Patient Testing

To prepare adequate healthcare measures in the case of a pandemic, vast numbers of people must be tested in order to understand the dynamics and behavior of the infection cycle. The medical staff working under extreme circumstances need basic but reliable laboratory supplies to help contain the pandemic. Read this special report to discover two solutions for COVID-19 patient testing that comply with guidelines from the US Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO). The…

Accelerating the Development and Manufacture of Therapeutics Using the Octet Platform

The high costs of therapeutic discovery, development, and manufacture require improved process efficiencies and economics. Analytical tools that eliminate the need for reagent labeling and enable real-time data visualization save development time and improve efficiencies during process development. The Octet biolayer interferometry (BLI) platform and assays can be used throughout process development and manufacturing, including cell-line development, clone selection, and dynamic binding capacity (DBC) determination for affinity purification columns. The ability of the Octet BLI platform to monitor binding interactions…