Author Archives: BPI Contributor

Making Media a Priority: An Interview with Susan Riley of Advanced Bioprocessing

Susan Riley is vice president and general manager of Advanced Bioprocessing. It’s been a year since Thermo Fisher Scientific’s acquisition of the Advanced Bioprocessing business from Becton Dickinson (BD). Why did Thermo Fisher see the Advanced Bioprocessing (AB) business as a good fit with its life-science offerings? AB has a significant portfolio in premium supplements for cell culture and microbial fermentation. The AB business was seen as a good fit for several reasons: It goes hand-in-glove with Gibco media, for…

Ask the Expert: Packing Rigid Chromatography Resins for Efficient, Optimal Results

Anna Le Bris (senior application specialist in bioproduction at Thermo Fisher Scientific) delivered an Ask the Expert webinar on 26 September 2019 to highlight the versatility of POROS chromatography resins. Conventional resin performance can change depending on hardware dimensions and capabilities. Thus, column packing can dictate other process parameters, and vice versa. But as Le Bris explained, POROS resins reduce the need for adaptation. Their beads are chemically stable and noncompressible, enabling the resins to achieve strong resolution at a…

Ask the Expert: Scalable Purification Strategies for Viral Vectors and Vaccines

Viruses and virus-like particles (VLPs) raise unique challenges for downstream recovery and purification. In an Ask the Expert webinar on 19 September 2019, Mark Snyder (R&D applications manager of process chromatography at Bio-Rad Laboratories) discussed purification methods engineered to perform at manufacturing scales. Offering case studies featuring Nuvia resin and CHT Ceramic Hydroxyapatite chromatography support, Snyder emphasized that scalable media can help companies optimize downstream operations and address evolving manufacturing requirements. Snyder’s Presentation Tremendous growth in markets for vaccines and…

Ask the Expert: Risk-Based Approaches to Software Systems Compliance

Software risk management often seems synonymous with extra documentation. But during a 17 October 2019 Ask the Expert webinar, Martin Laferriere (director of information technology services at Avid Bioservices) explained how a thoughtful risk- assessment process at early project management stages can optimize software system validation efforts. Laferriere illustrated the benefits of developing strategic structures for documenting system use, hazards, and testing requirements. Such structures can help biomanufacturers clarify what records and functionalities they need to concentrate on to remain…

Ask the Expert: Rapid Virus Quantification in the Development and Manufacture of Emerging Therapies

The development and manufacture of emerging viral therapies is highly dependent upon accurate infective virus titers as well as total particle counts. But traditional quantification technologies have not kept pace with the needs of the viral vector market. Quantification methods based upon infectious particle counts can easily underestimate total particle counts. Indirect measurements such as enzyme-linked immunosorbent assays (ELISAs) and quantitative polymerase chain reaction (qPCR) are prone to overestimating the number of virus particles because they measure virus components to…

Case Study in Conducting Chemical Safety Assessments for Single- and Multi-Use Manufacturing Components

This webcast features: Dr. Sherry Parker, Senior Director, Regulatory Toxicology and Technical Services, WuXi AppTec Extractable and leachable studies of single- and multi-use manufacturing components should be followed up with a chemical safety assessment to understand the chemical risks based on the toxicity of the chemical, the dose and the exposure duration of the drug product, and the patient population for its intended use. This case study will illustrate considerations when conducting a chemical safety assessment, the pitfalls of having…

Why Characterizing Protein Stability Matters For Drug Development

Characterizing a protein’s stability provides key insights into the expression, signaling, and regulatory roles of a molecule. This is necessary for numerous applications from understanding the molecular basis for certain diseases to ensuring more effective drug development. Ultimately, the stability of a protein is closely tied to its functional activity. Whether you’re just starting to learn about characterizing protein stability or you’re looking for a refresher, this guide has some helpful tips to answer why it’s important, what technologies are…

Ten important lessons the cell and gene therapy industry can take from the bioprocessing industry

It’s time to tackle the challenges of sustainable and cost-effective commercial manufacturing regarding cell and gene therapy. Cell and gene therapies have many of the same manufacturing needs as biopharmaceuticals. As a result, industry experts expect single-use technologies used in biopharmaceutical clinical trials and commercial production to play a larger role in the future development and production of cell and gene therapy. Single-use systems are already incorporated in the development of cell and gene therapies today. However, many of those…

Closed, Single-Use TFF Assembly Makes Performance-Leading TangenX Cassette Technologies Even Easier to Use

This webcast features: Michael LaBreck, Global Bioprocess Sales Specialist, TangenX™ TFF Products SIUS-Gamma TFF cassettes incorporate the performance-leading TangenX™ TFF membrane and cassette manufacturing technologies into a closed, gamma-irradiated, single-use assembly. Genderless, aseptic connections easily integrate into your current UF/DF flow path, and a library of 64 MWCO and surface area configurations provide rich process options. The closed format, leading TFF performance (flux, selectivity, reproducibility) of the TangenX membrane and manufacturing innovations that enabled the first single-use by design TFF…

Asahi Kasei Bioprocess’ Planova SU-VFC: Realizing Single-Use Technology in Virus Filtration

This webcast features: Brian Crawford, Director of Operations, Asahi Kasei Bioprocess America, Inc. By eliminating the need for clean-in-place, reducing demands on quality control, and optimizing product changeover times, single-use systems offer great benefit at pilot, clinical, and commercial production scales. The new Planova™ Single-Use Virus Filtration Controller (SU-VFC) from Asahi Kasei Bioprocess America, Inc. offers the hallmark consistency of Planova™ filters in a compact, fully automated single-use form factor with full 21 CFR Part 11 compliance for greater efficiency…