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A New AEX Mixed-Mode Chromatography Resin for High Selectivity and Recovery

This webcast features: Dr. Xuemei He, R&D Manager, Chromatography Media Chemistry, Bio-Rad Laboratories Biomolecules are becoming more diversified and complex. Bio-Rad’s newest hydrophobic AEX chromatography resin, Nuvia aPrime 4A, is engineered with distinct balance of ligand density and hydrophobicity. In this webinar, Dr. Xuemei He will introduce the properties of Nuvia aPrime 4A Resin. This mixed-mode resin is designed to facilitate selective and reversible binding of target molecules for higher purity and recovery over traditional chromatography resins. Case studies will…

The Proper Use of Extractables Data: Aspects Beyond Extractables Measurement

This webcast features: Dr. Armin Hauk, Lead Scientist, and Jean-Marc Cappia, Head of Segment Marketing Vaccines, at Sartorius Stedim Biotech The implementation and use of single-use system (SUS) in biopharmaceutical production is rapidly increasing and directly correlated with higher demands on Extractables and Leachables (E&L) information. Sartorius as a leader in SUS technology can look back on +20 years of experiences in the E&L area. This knowledge together with our current research initiatives enables us to progress and go beyond…

Integrity Redefined: Consistent Robustness and Integrity Testing Lead to Enhanced Process Integrity and Patient Safety

With the increasing adoption of single-use systems (SUS) in critical stages of biopharmaceutical manufacturing, any lack of system integrity can significantly affect drug product quality and patient safety, as well as incur additional costs due to product loss and disrupted production cycle. This article from Sartorius Stedim Biotech, describes how determining the correlation between liquid leakage and microbial ingress can be used to define MALLs (Maximum Allowable Leakage Limits) of SUS for different process steps. The article also details the…

Ask the Expert: Acoustic Cell Processing

As cell and gene therapies approach commercialization, the industry is looking for scalable manufacturing solutions. Equipment providers need to design specifically for the good manufacturing practice (GMP) environment and the unique needs of cell and gene processing. On 3 April 2019, Kevin Lannon of FloDesign Sonics presented an “Ask the Expert” on one company’s solution. LANNON’S PRESENTATION In a typical cell therapy manufacturing process, steps that require washing, concentration, or buffer exchange include centrifugation, filtration, and counterflow filtration. Each has…

Improving CHO Cells for Biomanufacturing

Chinese hamster ovary (CHO) cells have been used in biomanufacturing for decades because of their robust capacity to express a range of proteins, such as therapeutic enzymes and monoclonal antibodies (MAbs) at titers measured in multiple grams per liter of culture. Within the available suite of CHO cell lines, the glutamine synthetase knockout (GS-KO) selection system provides industry-leading speed to the identification of high-producing clones for use in biomanufacturing. The GS-KO selection system allows for identification of multiple-gram/L clones in…

Automating Workflow Solutions, Not Instruments: Engineering Validated Processes for Biologics Screening

This webcast features: Brian Bordeau, Business Development, Global Advanced Workflows and Engineered Solutions Automation can be a lifeline for scientists working in the discovery and development of biologics. The prospects for increasing sample throughput, reducing operator time, and streamlining data audit trails are alluring. However, at the same time, introducing automation can be a frightening and confusing project, with efforts often falling short of expectations for lack of bigger picture thinking. The Advanced Workflow Engineering Solutions (AWES) team at Molecular…

China’s Emergence in Global Biopharma Manufacturing: Trends in the Chinese Biopharma Industry

This four-part educational series, sponsored by BioProcess International and BioPlan Associates, Inc., highlights key trends emerging in China biopharmaceuticals, using select content BioPlan Associates’ 2018 2nd edition report, Advances in Biopharmaceutical Technology in China, 2nd Ed. The quarterly series, each consisting of articles, an e-book, 40-min webcast, and live presentation at select BPI Events cover China’s Emergence in Global Biopharma Manufacturing: Trends in Chinese Biopharma Industry. The projects include an Overview, Developments in Biologics, Biosimilars, and Global Expansion. The series…

Clearing the Way for Viral Clearance

This webcast features: David Cetlin, CEO, MockV Solutions and John Li, Staff Scientist, Thermo Fisher Scientific. To determine the viral clearance efficacy of biomanufacturing steps, mammalian viruses are “spiked” into in-process solutions, processed and analysed for reduction. Due to the infectious nature of these live viruses, “spiking studies” are typically conducted in specialized BSL-2 facilities. The costs and logistics associated limit viral clearance analysis during process development and characterization. To overcome this challenge, a non-infectious Minute Virus of Mice –…

Cell Culture Bioprocessing in Perfusion: Assessing Cell Retention Technologies

Upstream bioprocessing in perfusion mode holds great promise for industrial production of cells and biologics. In perfusion, fresh medium is added constantly to the bioreactor, and used medium is harvested while the cells are retained in the bioreactor. As a result, the composition of the cell culture medium stays quite constant during the process. This offers several advantages. In perfusion, higher cell densities can be reached than in batch and fed-batch processes, therefore enhancing volumetric productivity. Because medium composition can…

A Strategy to Remove Formulation Development from the Critical Path During Biologics Development

Biopharmaceuticals tend to be highly unstable. Therefore, as the product development program progresses to phase 3 clinical stage, formulation development is required to ensure drug product quality and stability during manufacturing, storage and clinical administration. Also, formulation development is often on the critical path to successful IND and BLA fillings. During this Q&A, Dr. Jun Lu, Director, Analytical Development, discusses how Catalent Biologics utilizes automation, specifically the Uncle platform, during formulation development. Login and click View PDF to view the…