Wednesday, September 29, 2021 Daily Archives

BioProcess Insider State of the Industry — September 2021 Panel Discussion

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Our BioProcess Insider editorial team sits down with Joshua Speidel, PhD Partner, Latham Biopharm Group, Patrick Lucy, President and CEO, Lykan Biosciences, and Amélie Boulais, Head of Market Entry Strategy, Virus Based Therapeutics at Sartorius, to reflect on how the quarterly movements of the wider pharma industry are affecting the biomanufacturing space. Through the analysis of global events, recent deal making, and regulatory and technological advancements, we look to determine the factors driving or squeezing production and pre-empt upcoming trends…

Ask the Expert: Facilitating Process Development Using a Microfluidic Perfusion Bioreactor

Suitable scale-down perfusion systems generally have been unavailable for process development (PD) activities. Some commercially available systems require daily media exchanges. No such system performs in a way that accurately represents large-scale perfusion, and none maintains sufficiently high cell densities. Kevin Lee (cofounder of Erbi Biosystems) joined BPI on 4 May 2021 to explain how his company’s Breez bioreactor system integrates all the functions of a stirred-tank reactor (STR) into a compact format that can facilitate PD, enabling one person…

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…

Ensuring Quality Oversight in Plasmid DNA Manufacturing

The landscape of today’s biopharmaceutical industry is changing rapidly with the introduction of novel drug products, such as personalized medicines. However, while this sector of the market is expected to have a major impact on patient care in the coming years, it also presents significant challenges during development and manufacturing. One such area is a gap in GMP quality plasmid DNA (pDNA) supply, an essential building block for viral vector and even mRNA based vaccines and therapies ― the latter…

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…

Missouri biologics expansion part of Thermo Fisher $4.3bn CAPEX plan

Thermo Fisher will invest $82.5 million in a Missouri drug substance facility run by its CDMO division Patheon. The expansion forms part of a three-year capital expenditure plan across its biopharma services divisions. News came in this week that life sciences firm Thermo Fisher Scientific has committed to plans to expand operations and create 169 new jobs at its Berkeley biologic drug substance manufacturing facility in St Louis, run by its contract development and manufacturing organization (CDMO) business Patheon. The…