Author Archives: BPI Contributor

Enabling Success in Biologic Drug Substance Development and Biomanufacturing by Leveraging Expertise and Collaboration

This webcast features: Steven Perry, PE, Senior Director of Manufacturing Sciences, Catalent Biologics Biologic drug substance development and biomanufacturing is a critical step in the long, complex pathway to approval. There are many considerations to be made around cell line and process development, analytical testing and late stage activities such as process characterization and validation. This presentation discusses: Critical drug substance resource needs of sponsor companies How expertise and collaboration amongst the key stakeholders enables successful development and scale up…

Don’t Just Pass the Baton: Comprehensive Capabilities and Parallel Processes Accelerate Biologic Development Timelines

Biologic drug development from DNA to commercialization involves many moving parts, which can be difficult for companies to coordinate. For example, there are often new expert stakeholders introduced during each stage of development, leading to inefficiencies and confusion. However, with deep expertise and effective communication between teams, companies can reduce risk and shorten time to clinic and, subsequently, to market. In this webinar series, three biologics subject matter experts will discuss critical considerations in their respective areas of expertise: drug…

Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment

This webcast features: Dr. Anshuman Shukla is Intertek’s Biophysical Characterisation expert at the Center of Excellence for Biopharmaceuticals in Manchester, UK. Structural integrity of protein based therapeutics is one of the major challenges in the biopharmaceutical industry where multiple factors such as the stability, efficacy and shelf life could be affected following minor changes in manufacturing process. This becomes critical particularly with development of more and more biosimilars where comparability to a reference product is required to ensure that the…

Introducing Chromassette: Modular Chromatography Platform with a Lattice Supported Bed

This webcast features: Jason Chiu, Product Marketing Scientist, Bioprocess Group, JSR Life Sciences. Chromassette®, a lattice-supporting modular chromatography device, eliminates the constraints of modern column chromatography. The Chromassette technology offers the separation capabilities of conventional chromatography plus the convenience, scalability and other benefits of a pre-packed cassette through its unique, internal scaffold structure that provides consistent “wall support” to all resin beads. In this webinar we will discuss how Chromassette enables high flow-rates for any type of resin regardless of…

The Complete e-Book of Biosafety Testing

Expect the expected. But plan for the unexpected. If your Biosafety Development takes a nose dive, Eurofins Lancaster Laboratories’ team of regulatory experts and experienced scientists will help you land safely on two feet. Download The Complete e-Book of Biosafety Testing to learn more about our expertise in biologics raw materials, cell bank preparation, adventitious virus testing, viral clearance studies, next-generation sequencing, genetic stability testing, and more. This e-Book contains the following chapters: Mitigating Risk and Reducing Regulatory Scrutiny of…

Bioproduction Media Optimization Through Spent Media Analysis

This webcast features: Matthew Smonskey, R&D Scientist, Gibco Bioproduction Services Group, Thermo Fisher Scientific Individual cell lines have unique nutritional requirements which may not be satisfied using catalog media. These deficiencies often result in less than optimal recombinant protein yields during a bioproduction process. This presentation will discuss resources available to identify these media limitations and options for designing custom media formulations in order to maximize protein yields. Just fill out this form to watch the recorded webcast now.

Preparing for and Managing Regulatory Inspections

This webcast features: Ray Marzouk, Vice President of Quality at Avid Bioservices Inc. Nothing gets your heart racing faster than receiving a call from your lobby notifying you that a regulatory authority has arrived to perform an inspection. However, with proper preparation and established inspection management protocols in place, navigating a regulatory inspection doesn’t have to be a scary proposition. As a CDMO manufacturing commercial products since 2005, Avid Bioservices Inc. has successfully hosted several regulatory GMP inspections and PAIs…

Characterization and Lot Release Assays for Antibody Drug Conjugates

Antibody-drug conjugates (ADCs) add an additional level of challenge to testing of biotherapeutics. Besides the antibody, which needs to be evaluated for potential and known mechanisms of action (MoA), there is a cytostatic compound conjugated that alters the behavior of the antibody-vehicle within the typical assays. Therefore, characterization of new innovators as well as biosimilarity assessment is even more challenging than it is for antibody therapeutics. Using the example of Trastuzumab emtansine, Charles River has set up a panel of…

Keeping Host Cell Protein ELISAs Covered

Biological drugs (or biologics) are manufactured by living systems such as microorganisms, and plant and animal cells. Cell lines, like Chinese hamster ovary (CHO), can be engineered to work as cellular factories to produce biologics in addition to their own biological molecules. Host cell proteins (HCPs) are biological by-products of these cellular factories. They are one of the main impurities in harvested cell culture fluid (HCCF), and tend to be released when the cells die or are damaged. These HCPs…

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

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…