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High Productivity Harvest – Intensify Harvest and Displace Depth Filtration in Fed Batch Cell Culture

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This webcast features: John Bonham-Carter, Director of Upstream Sales, Repligen High Productivity Harvest (HPH) is a novel application developed by Repligen that enables you to harvest a fed batch bioreactor in a fully sterile manner while eliminating both centrifugation and depth filtration. A 0.2µm filtered, closed system and single step process using the XCell™ ATF System, HPH can significantly increase yields above industry standards and generate a sterile clarified batch harvest ready for either batch or continuous chromatography. This webinar…

November 21, 2018

Webcast: Accelerating Vaccine Production with Non-Viral Cell Engineering

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This webcast features: Victor Ayala, PhD, ABL Inc. Protein expression for manufacturing falls into one of two basic categories: stable cell line generation or transient transfection. While stable cell lines provide consistency in product quality and quantity, they are also expensive and time-consuming especially in early discovery and development phases. In this webinar, a fully-scalable cell engineering technology employing a transient transfection strategy will be discussed. This technology has allowed for the efficient and cost-effective evaluation of vaccine candidates in…

November 21, 2018

Flow Cytometry News: Does your lab comply with 21 CFR Part 11?

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21 CFR Part 11 refers to the section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Chapter 21 covers all regulations pertaining to GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice), relating to the pharmaceutical and healthcare industries. Part 11 covers all FDA regulated issues pertaining to electronic records and electronic signatures. All computer systems that store…

November 6, 2018

Improving CHO Cell Biomanufacturing via Whole Genome CRISPR Screening

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This webcast features: Jamie Freeman, PhD, Product Manager, Horizon Discovery While Horizon’s GS knockout CHO K1 cell line is rapidly becoming established as one of the best performing cell lines available for the manufacture of biotherapeutics, there is untapped potential within the CHO system. Horizon is focused on using its expertise in genome engineering techniques to modify CHO cell lines to improve their expression capacity for biomanufacturing. Historically, efforts to increase yield have primarily focused on improving media and feed,…

November 5, 2018

Use of Systematic Tools to Expedite Process Characterization and Maximize Reliability of Process Validation Campaigns

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This webcast features: Abel Hastings, Director of Process Sciences, Fujifilm Diosynth Biotechnologies During this webcast you will learn how using a suite of tools, standard practice, and depth of experience in PPQ readiness are aimed at: Effectively focusing attention on critical process understanding and control Scoping and completing the ideal scope and range of characterization Studies to support reliable operations in manufacturing Maximizing reliability during PPQ and commercial manufacturing Enabling full preparedness for PAI and regulatory review

October 31, 2018

Viral Risk Mitigation: A Global Regulatory Perspective

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The production of biologics will always have the risk of viral contamination. Manufacturers have developed a multitiered approach — tailored to individual processes — to prevent adventitious viruses from entering production processes, detect contamination in raw materials and process intermediates, and remove viruses in downstream purification. This article provides an overview of the global regulatory framework to ensure the viral safety of biologics. Past Contamination Events Past contamination events have resulted in corrective and preventative actions to reduce the risk…

October 30, 2018

The Challenge of Building Better, Lower Cost Biologic Drugs Faster

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A critical factor for both the lowering in costs of development as well as costs of production for biologic therapies is to develop a cell line that grows faster and produces larger amounts of vaccines and drugs using low cost synthetically defined media. Dyadic’s industrially proven C1 gene expression platform creates a stable cell line in a shortened timeline, reducing the time from gene fragment to stable cell line by 50% when compared to CHO cells. C1 stable cell lines…

October 25, 2018

Development of a Standardized Extractables Approach for Single-Use Components: General Considerations and Practical Aspects — A Manufacturer’s Perspective

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The subject of extractables for single-use bioprocess contact materials has been a subject of heated debate since roughly the summer of 2012, when the first ISPE paper was published issuing a call to action to develop a standardized extractables protocol for the industry (1). As a supplier that pioneered the science of extractables (2‒11) and has published extractables data for our products for over 20 years, Sartorius Stedim Biotech (SSB) took the opportunity to look back, take stock, rationalize, and…

October 23, 2018

Sticking In or Standing Out? Dichotomy in Vaccine Purification By Chromatography

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A general vaccine purification strategy can be divided into three stages, with one or more steps for each stage. The first stage is to concentrate and isolate the target molecule quickly to remove it from conditions that could lead to its inactivation or loss. Intermediate purification seeks to remove remaining contaminants, typically using an orthogonal approach. That is followed by a polishing step in which trace impurities are removed through high-efficiency steps because those impurities usually are similar to the…

October 15, 2018

Process Analytics and Intermediate Purification of Bispecific Antibodies with a Non-Affinity Platform

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The therapeutic benefits of monoclonal antibodies (MAbs) have been demonstrated in recent decades with uncontestable success as treatments for human disease. Despite MAbs’ key features such as specificity, selectivity, and safety, the format has limitations (1, 2). Bispecific antibodies may overcome number of difficulties (3). Multiple formats of bispecific antibodies have been developed, although only the κλ-body is fully human and devoid of linkers or mutations. It requires no genetic modifications of heavy and light chains and results in bispecific antibodies…

October 15, 2018