Webinars

Validation of the MycoSeq Mycoplasma Detection Kit for the Release of Veterinary Products

This webcast features: Sébastien Lievyns, Scientist, and Dr. Anne Thomas, Senior Principal Scientist, Analytical Sciences, Zoetis This webcast aims to show how Zoetis has validated the MycoSeq kit for the release of animal products. The Analytical Sciences group at Zoetis confirmed the limit of detection at 10 CFU/mL and good repeatability and intermediate precision of the qualitative mycoplasma qrt-PCR method in presence of these products. For direct PCR performed on vaccine, a background amplification is sometimes observed inducing a signal…

KrosFlo KR2i with KONDUiT: Turnkey Benchtop System for Walkaway TFF Automation

This webcast features: Philip Yuen, PhD, Application Scientist, Repligen Perform efficient, fully automated downstream tangential flow filtration with volumes from 1mL to 10 Liters. Fully integrated and easy to use out of the box, the Spectrum® KrosFlo® KR2i TFF System from Repligen is the lowest priced fully automated system available today that delivers precise and reproducible control and documentation of TFF processes. The system is compatible with hollow fiber or flat sheet filters, and offers a number of user-defined set-point…

Setting Up a Rapid Mycoplasma Assay Supporting Recombinant Production

This webcast features: Kent Persson, PhD, Project Manager, Octapharma Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines states that recombinant bulk harvest need to be tested for mycoplasma prior to further processing. The presentation will give the overview on a nearly completed journey on replacing an out-sourced mycoplasma test with Thermo Fisher’s MycoSEQ qPCR assay. Octapharma in Stockholm has recently been sought regulatory approval for the…

Scaling Up? No Problem with New 80cm Diameter Pre-packed OPUS Columns

This webcast features: Fletcher Malcom, Director of Product Management, Downstream Technologies, Repligen The technical and economic benefits of ready-to-use, pre-packed chromatography columns have been proven and documented. The question remains, how large can we go? This presentation will show how the unique design of the new 80cm pre-packed OPUS column delivers chromatographic performance, and how usage can result in substantial cost and time savings for clinical and commercial scale manufacturing. Watch the recorded webcast on-demand.

Advantages of Fluoropolymer Single-Use Systems

This webcast features: Eric Isberg, Director of Life Sciences, Entegris There remain significant performance risks restricting the use of disposables in bioprocessing. These factors include bag breakage, which is particularly evident in cold temperature applications; concerns around E&L and material purity; and use of materials which are incompatible with the process itself. Improved plastics are required to meet existing and future process needs; fluoropolymers appear to be very promising to achieve these goals. Fluoropolymers’ unmatched characteristics are inherent to their…

Developing a Whole Genome CRISPR Screen to Improve CHO Cells for Biomanufacturing

This webcast features: Jamie Freeman, PhD, Product Manager, Horizon Discovery While great strides have been made in increasing the yield of biotherapeutic proteins, these have been achieved mainly through process improvement with a particular focus on media and feed strategies. Aside from single gene knockouts to allow for metabolic selection systems, the CHO host itself remains largely unchanged from that which was used thirty years ago. This webcast will cover how Horizon Discovery has used the recently released annotated sequence…

Integration of Cell Line, Process and Analytical Technologies to Speed Development and Clinical Supply of Emerging Therapy Products

This webcast features: Stewart McNaull, senior vice president of Business Development, KBI Biopharma, Inc. With biopharma’s ever-evolving pipeline of novel protein therapeutics, such as bi-specific antibodies, multimeric proteins, Fc-fusion proteins, and advanced monoclonal antibodies, CHO cells are being pushed to their productivity limits in drug development and manufacturing. Biopharmaceutical companies working on these promising new therapies increasingly struggle with development challenges such as weak protein expression, low-yield purification steps, and poorly optimized analytical techniques. As innovators address these challenges, robust…

Important Considerations in Successful Viral Clearance Studies

This webinar features: Esha Vyas, Field Applications Manager, Asahi Kasei Bioprocess America Virus filtration is a critical unit operation in the manufacture of biotherapeutic products. Rigorous and careful validation of this process-dependent step is necessary to demonstrate that the selected virus filter meets regulatory requirements. Thoughtful design and implementation of spiking studies are imperative to successful validation, and these studies may include consideration of various robustness and process parameters. Overall, the study design should be conducted as a representative scaled-down…

Planova BioEX: Leading the Next Generation of Virus Filters

This webcast features: Daniel Strauss, PhD, Principal Scientist, Research and Development group at Asahi Kasei Bioprocess America Virus filtration is a critical unit operation in the manufacture of biotherapeutic products owing to its capability to remove a broad range of viruses. Selection of virus removal filters based on filterability and virus removal performance over a range of process conditions ensures predictable processes. The Planova™ BioEX filter shows high flux with minimal flux decay for some of the most challenging products…

Evaluation of the “Scale-Out” Biomanufacturing Strategy from Early Clinical Stage to Commercialization

This webcast features: Jie Chen, MD, MS, Vice President of CMC Management, WuXi Biologics   The success of therapeutic biologics over the past decades has reshaped the pharmaceutical industry landscape. From orphan to biosimilar to novel blockbuster drugs, the production demands can range from grams to metric tons of biopharmaceutical products each year. This diverse range in manufacturing scale coupled with thousands of biologics in the development pipeline, has had significant impact on the design of biologics production models.  Without…