Webinars

Bioprocess Insights Webinars

The biopharmaceutical industry has developed into a multi-billion dollar market in just 30 years. Making decisions and setting up strategies in a rapidly changing environment can be challenging. The difference between a good and a great decision can have extensive implications for the future of a company. In this environment, knowledge and experience are what make the difference. Good insights about, for example, technical advancements, process economy implications, and sustainability aspects can help improve the individual decisions and strengthen the…

Objective Characterization Data on Drug and Gene Delivery Platforms

This webcast features: Dr. Josefina Nilsson, Head of Vironova Services, as well as her colleagues, Gustaf Kylberg and Mathieu Colomb-Delsuc. Advanced analytics that provide objective and reliable data can help to improve processes and shorten development time of drug and gene delivery platforms. The use of electron microscopy (EM) imaging combined with analysis using the proprietary Vironova Analyzing Software (VAS) enables semi-automated particle detection and classification. Statistically significant results are obtained in a time and cost effective manner. Typical data…

Eliminating the Ups and Downs of Staffing Challenges

This webcast features: Beth DiPaolo, M.A., SPHR, President, Eurofins Lancaster Laboratories Professional Scientific ServicesSM Many pharmaceutical and biopharmaceutical companies are currently experiencing strong development pipelines, but they face challenges associated with balancing the expanded workloads with restrictions on employee headcounts. To combat this, companies often turn to temporary staffing; however, due to the challenges in finding, training, and retaining motivated talent, the temporary staffing model does not meet current demands in these areas. As an expert with 14 years of…

Single-Use Biopharma Product Recycling: An Alternative Process to Unlock the Challenges

This webcast features: Jacqueline Hollands Ignacio, Corporate Responsibility Programs Manager – Customer Initiatives, MilliporeSigma, and Michael Farrell is Corporate Disposal Coordinator, Triumvirate Environmental. As the biopharmaceutical industry increases the adoption of single-use manufacturing products, the issue of recycling becomes a challenge. Disposal and recycling the plastics from these products is a challenging task due to many factors such as limitations within the recycling infrastructure, products containing a mix of materials and plastics, and biopharmaceutical products can contain biologically hazardous materials…

High Performance Cell Retention Technology for Cell Culture Process Intensification

This webcast features: Millie Ullah, PhD, Associate Director of Upstream Product Management and Marketing, Repligen The move toward continuous processing and intensified processes is a paradigm shift in bioproduction. In upstream cell culture, the challenge is to simplify and minimize process steps (N-1 perfusion) while intensifying cell retention and viability (high density cell expansion). This webcast will present a case study where use of the ATF cell retention system in process intensification of a fed-batch culture resulted in successful N-1…

An Extractable and Leachable Program for Assessing Single-Use Components and Systems

This webcast features: Chris Shields, Director of Global Product Validation Services at Saint-Gobain Life Sciences. Extractable testing is traditionally performed by single-use suppliers, and while not required by industry regulations, it is the drug manufacturer’s expectation that this information form part of a product’s data package. Extractable and leachable testing is designed to determine the chemical compounds that may migrate into the customer’s fluid from the single-use product’s fluid contact layer. Extractable testing utilizes aggressive but relevant test conditions, while…

Refolding of Biopharmaceuticals by FOLDTEC: A Case Study on Recombinant Thrombin

This webcast features: Dr. Andreas Anton, Director Bioprocess Development and Dr. Sebastian Schuck, Senior Manager Business Development, Wacker Biotech While WACKER’s own technology ESETEC® has proven highly efficient in producing soluble proteins and antibody fragments via secretion, poorly soluble substances form aggregated inclusion bodies within the cell, which contain incorrectly and/or incompletely folded target proteins. Recently Wacker Biotech introduced FOLDTEC®, its novel refolding technology for bioengineered pharmaceutical proteins. With this new technology, biopharmaceuticals that tend to aggregate can be efficiently…

Development of a Novel Thermoplastic Tubing, FP-FLEX and Single-Use Freezing Bag for Working Cell Banks Enabling Closed-System Processing to Temperatures as Low as -196 °C

This webcast features: Dominic Clarke, Global Product Manager, Charter Medical Working cell banks (WCB’s) are commonly applied to initiate cell culture manufacturing campaigns for production of recombinant or therapeutic proteins. These campaigns typically begin with inoculation of cells previously cryopreserved in cryovials.  While cryovials are typically used in the development of WCB’s and initiation of manufacturing campaigns, they are not optimal for the growing demands of commercial production. Cryovials are small and filling/removal is performed through an open screw cap. This…

Product Quality Assessment using N-linked Glycan Analysis by LC-MS Supports Identification of Commercially Viable Cell lines for Biopharmaceuticals

This webcast features: Gareth Meek-Brown, Lead Scientist, Lonza Biologics – Slough Product Quality assessment during Upstream and Downstream Process Development is key to the production of safe and efficacious biopharmaceuticals. Critical quality attributes such as N-linked glycosylation are highly dependent upon biosynthesis conditions and play a crucial role in the pharmacology of therapeutic proteins, potentially affecting immunogenicity, pharmacokinetics and pharmacodynamics. The presence of N-linked glycosylation has benefits including increased thermal, physical and chemical stability over aglycosylated variants. The optimum N-linked…

Optimizing Cell Culture Productivity: New Findings on the Impact of Recombinant Protein Supplements

This webcast features: Harris Grevelis, Product Manager for Upstream Technologies at Repligen Cell culture supplements are essential for long-term growth and productivity of cell lines in serum-free media formulations. Both insulin and LONG®R3 IGF-I, a more potent supplement that directly targets and activates the IGF-I receptor, are employed by the biopharmaceutical industry today to support the growth of recombinant cell lines. This webinar will show how these two supplements, used separately and in combination, impact viable cell density and IgG…