Regulatory Strategies for the Analytical Development of New Biological Entities and Biosimilars

The webinar will focus on the relationship between analytics of biotherapeutic products and the interpretation of data to build and support a solid regulatory Chemistry, Manufacturing and Control (CMC) strategy. The importance of data interpretation is illustrated in the development of biosimilars and new biological entities, as well as in regulatory specifications regarding biotherapeutic products.
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OTHER ON-DEMAND WEBINARS

Therapeutic Antibody Discovery by Mammalian Display

MaxCyte

Using directed integration of antibody genes by CRISPR/Cas9 and TALENs, the construction of large libraries in mammalian cells containing a single antibody gene/cell has been achieved. This accomplishment has enabled the construction of libraries containing millions of monoclonal, stable, cell lines displaying IgG-formatted antibodies on their surface, and from which novel, high-affinity binders can be isolated. This technology also allows for the selection of antibodies with improved biophysical properties from libraries of variants.
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Let’s talk TOC and conductivity requirements for pharmaceutical water systems

europeanpharmaceuticalreview

This webinar addresses the requirements for continuous monitoring of water for injection (WFI) systems and how this can be achieved with total organic carbon (TOC) and conductivity. It will also cover cold WFI production according to EP and how it applies to water systems.
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The Role of Technology in Precision Diagnosis

HIMSS Media

Individualized, precision medicine is an evolving medical model and is key in helping clinicians reach accurate diagnoses and effective treatment plans for many patients. There are much promise and hype around precision medicine, but implementing and scaling a precision medicine program is challenging. Multiple disciplines must collaborate in order to reach an accurate diagnosis and effective treatment plans. Unfortunately, information is frequently in sales, disparate systems, or lost.
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Improving Sterilising Filtration in the Biopharmaceutical Industry

business-review-webinars

Sterile filtration has been a cornerstone of bioprocessing for over 60 years and as the industry continues its change from stainless steel to single-use, filtration has also evolved, moving from cartridge to capsule format with several membrane types to choose from. This webinar aims to provide an overview of filtration in bioprocessing addressing key considerations when developing a biopharmaceutical manufacturing process.
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