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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…

Accelerating Intensified Bioprocesses with High-Throughput Small-Scale Tools

While many biopharmaceutical companies are exploring paths toward continuous processing, many tools already exist for implementing process intensification. As the authors of this special report illustrate, hybrid continuous processes that benefit from single-use technologies along with continuing improvements in perfusion cell culture already now are enabling improvements in cost reduction and accelerating time to market. And novel high-throughput and automated small-scale systems are helping development scientists gather more information in less time than before, reduce their development footprints, and make…

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…

Single-Use Bioreactors: Performance and Usability Considerations Part 1: Performance for Process Control

There is ever increasing pressure for the biopharmaceutical industry to drive toward higher efficiency and lower costs. Compared to the past, target markets for many drugs typically are becoming smaller, and so-called blockbuster drugs are becoming more the exception than the rule. Regulatory agencies have continued to increase the pressure on drug makers to meet increasing quality standards and accept higher levels of responsibility. Furthermore, customer pricing, healthcare markets, and recent biopharmaceutical pricing scandals all add incentives toward more efficient…

PDB-Dimer Payloads for Antibody Drug Conjugates: A Robust Approach to cGMP Production

From the 1960s when monomeric pyrrolobenzodiazepines (PBDs) such as anthramycin were isolated and characterized, to the dramatic increase of potency induced by dimerization in the 2000s, PBD dimers have evolved as one of the leading classes of antibody drug conjugate (ADC) payloads. Currently, 17 ADCs are in clinical trials involving PBD-dimers — second only to auristatins (23 ADCs), and more than those with maytansines (16 ADCs). Four different PBD-dimer ADC payloads are in clinical trials: Talirine (SGD-1910) from Seattle Genetics;…

Accelerating Vaccine Production Using a Nonviral Enabling Technology for Cell Engineering

At the recent World Vaccine Conference, Victor Ayala, PhD, an early stage investigator with Advanced BioScience Laboratories, Inc. (ABL), discussed how to accelerate vaccine production using a nonviral enabling technology for cell engineering. ABL is a contract research/manufacturing organization (CRO/CMO) providing manufacturing and laboratory research services to advance leading vaccines and therapies from clinical development to the commercial market. The company has been conducting R&D research for over 55 years and performing CMO manufacturing for over 25 years. With more…

Ask the Expert: Developing a Whole-Genome CRISPR Screen to Improve Chinese Hamster Ovary Cells for Biomanufacturing

Great strides have been made in increasing the yield of biotherapeutic proteins mainly through process improvements with a focus on media and feed strategies. But aside from single-gene knockouts to allow for metabolic selection systems, the Chinese hamster ovary (CHO) host cell line remains largely unchanged from what was used 30 years ago. In a webinar on 21 March 2018, Jamie Freeman (product manager at Horizon Discovery) focused on this as a bioproduction application of clustered regularly interspaced short palindromic…

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…

EZ BioPac® Powder Transfer Gets Your Biologic to Market Faster, with Less Risk

This whitepaper quantifies how one simple change can drastically reduce the time it takes to get biologics manufactured. Getting media and buffer into large-scale, continuous bioprocessing has been burdensome, time consuming and messy. Upgrading to modern single-use powder handling in your process gets your product to market without time wasted on complicated weigh and dispense steps, cleaning validations, or worries about powder in the air and in the room.

Directed Differentiation of cGMP Compliant Human Induced Pluripotent Stem Cells Into Clinically Relevant Specialized Cells From All Three Germ Layers

The generation of human induced pluripotent stem cells (iPSCs) via reprogramming technology represents a major breakthrough in personalized medicine and the treatment of degenerative diseases. This is mainly because the iPSCs can be expanded in culture and then differentiated into specialized cell types that can be used for clinical applications. Patient-derived iPSCs can be used to model human genetic diseases, produce clinically relevant differentiated cells that display disease pathogenesis, or generate specialized cells through directed differentiation process for autologous cell…