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Best Practices for Aseptic Sampling from Stainless Process Equipment

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This webcast features: Bobbi Allen, Technical Expert, Aseptic Sampling, Sartorius Stedim Biotech Aseptic sampling from stainless process equipment is a regulatory requirement and can be accomplished in many ways. How samples are removed from the process stream and the containers you collect them into can have an impact not only on the integrity of the process but the accuracy and repeatability of the tests you are performing. Emerging technologies can streamline sample taking, minimize risk to process, and improve the…

January 10, 2020

Trends in Data Analytics As Organizations Undergo a Digital Transformation

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The biopharmaceutical industry is in the midst of an exciting transformation as biologics experience massive growth — even outpacing the small-molecule segment (1). Biologics are predicted to comprise over a quarter of the pharmaceutical market in 2020 (2). At the same time, a plethora of new biologically derived therapy concepts — e.g., cell and gene therapies — are in development. Some biologics classes have become mainstream — e.g., monoclonal antibodies — with biosimilars entering the market and contract manufacturing organizations…

December 20, 2019

A CDMO’s Perspective on the Development of Bioprocesses for Clinical Manufacturing Success

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This webcast features: Nigel Shipston, Director, Program Design, FUJIFILM Diosynth Biotechnologies A strategy for the development and scale of bioprocesses should be assessed at the earliest of stages. There are different challenges depending on the molecule and expression system. This webinar is designed to address some of the areas of consideration for successful development of bioprocesses for biologics and gene therapies. At the end of this webinar, you will be able to do a self-assessment to answer some critical questions:…

December 20, 2019

The Proof Is in the Data: Extractables and Leachables

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Extractables and leachables (E&Ls) must be addressed in material and process validation programs. Extractables are compounds that can be extracted from a material in the presence of solvents with varying polarity under extreme conditions. Materials manufacturers should make extractables guides available to end users. Leachables are compounds that migrate from a material in the presence of an actual formulation under normal process operating conditions. Extractables information can be helpful as a basis for evaluation of potential process-equipment–related leachables (PERLs)testing. However,…

December 19, 2019

High Titer Recombinant Lentivirus and Adeno-associated Virus Production for Therapeutic Applications

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Increase your recombinant lentivirus and adeno-associated virus (AAV) production with a novel transfection formulation, TransIT-VirusGEN® Transfection Reagent, specifically designed for large-scale virus production to support gene and cell therapies. This poster highlights TransIT-VirusGEN® for use in adherent or suspension cell culture platforms along with enhancers that significantly increase functional virus titers over PEI based formulations. Testing was performed with multiple serum-free media formulations and examined using different plasmid DNA concentrations to better address compatibility within various workflows. Download the poster…

December 17, 2019

Monoclonal Antibody Aggregate Polish and Viral Clearance Using Hydrophobic-Interaction Chromatography

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Hydrophobic Interaction chromatography (HIC) is a powerful polishing tool for the downstream purification and manufacture of biotherapeutics. HIC offers orthogonal selectivity for the clearance of difficult process and product-related impurities such as aggregates, host cell proteins and endogenous and adventitious viruses.  In this study, a family of POROS HIC resins with novel ethyl and benzyl chemistries was used to successfully polish two clinical stage monoclonal antibodies harboring very high levels of product aggregation (>10%). In addition to aggregate removal, viral…

December 16, 2019

Risk and Lifecycle Management for Biopharma Operations

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By working with the best biopharmaceutical companies for over a decade, 4Tune Engineering (4TE) has built a portfolio of services that enables companies to address current-century challenges. The biotechnology industry needs to address advanced therapies and personalized medicines and deliver explicit patient outcomes. Biologics today fall into four categories: monoclonal antibodies (MAbs), biosimilars, advanced therapeutic medicinal products (ATMPs), and cell and gene therapies (CGTs). Consequently, we can ask whether our manufacturing science and technology (MSAT) approaches are up to the…

December 16, 2019

AAV Vector Manufacturing Platform Selection and Product Development

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Adenoassociated virus (AAV) vectors have emerged as the prominent delivery mechanisms of corrective gene therapies. Three such products — Glybera (alipogene tiparvovec, uniQure), Luxturna (voretigene neparvovec-rzyl, Spark Therapeutics), and Zolgensma (onasemnogene abeparvovec-xioi, AveXis) — have been licensed, and a growing number of candidates are entering late-stage development. In mapping out an AAV gene therapy product development strategy, biomanufacturers should address fundamental considerations for their manufacturing strategies for both phase 1–2 clinical evaluation and translation for commercial market supply. A manufacturing…

December 16, 2019

The Road to Commercialization: A Commercial CDMO’s Perspective

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Richard Richieri, chief operation officer (COO) of Avid Bioservices, recently presented an Avid case study and strategy to design, prepare, and execute process validation in preparation for successful product approval inspections. The goals of the presentation were to share lessons about some of the strengths learned from Avid’s experience and to offer advice on industry best practices. Finding a CMO that meets your quality expectations and scale is a key driver for your eventual commercial success. Particularly, working with CMO…

December 10, 2019

Matrix: The Highly Automated Multibioreactor Solution That Fits to Your Bench Space, Bioprocessing Needs, and Budget

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To improve their bioprocess performance, life-science specialists need flexibility in their R&D laboratories because of constantly changing bioprocessing demands. In addition, more experiments need to be performed with more accuracy and reproducibility on less bench space than ever before — and with limited budgets. Therefore, having flexibility in the number of bioreactors that fit available bench space and budget is crucial — along with the flexibility to connect and integrate the right software, sampling tools, and analytical devices. Running multiple…

December 10, 2019