Thursday, September 22, 2022 Daily Archives

Robust Methods for Stability and Identity Testing of Cell and Gene Therapies

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This webcast features: Sameer Kalghatgi, PhD, Director of Molecular Biology, WuXi Advanced Therapies. Genetic stability and identity testing are necessary for novel cell and gene therapies to achieve regulatory approval. Sanger Sequencing, human cell line identification using short tandem repeats (STRs) and next generation sequencing (NGS), are important tools for identity and stability testing but must be implemented in a reproducible way. For regulatory approval, the identity and stability of transfected DNA inserts must be confirmed. Sanger Sequencing is widely…

September 22, 2022

Fine-tuning Transient Transfection Conditions is a Prerequisite for Optimal Upstream AAV Manufacturing

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Setting up robust and reproducible bioprocesses is a top priority for all biotechnology companies focused on developing life changing AAV-based gene therapies. To do so, innovators crave for breakthrough technologies to maximize productivity while controlling the cost of goods (CoGs) of their AAV vector manufacturing workflow, key to accelerate the speed to commercialization of their clinical programs pipeline. Helper-free triple plasmid transfection of HEK293 cells – adherent or suspension – is the most used upstream method for AAV manufacture. Observing…

September 22, 2022

Danaher merging Cytiva and Pall to create $7.5bn bioprocess juggernaut

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Combining Cytiva and Pall will create the “broadest” and “deepest” bioprocess product portfolio in the industry, says Danaher Corporation. The decision to create ‘The Biotechnology Group’ by merging Danaher’s two bioprocess businesses was announced at the firm’s 2022 Investor & Analyst event last week. Introducing the combined entity, Danaher CEO Rainer Blair told stakeholders the decision represents the third phase in his company’s acquisitional strategy in the bioprocess space, having first acquired and “carved out” the two businesses – Pall…

September 22, 2022

Catalent hit with FDA 483 at Bloomington plant

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A US FDA Form 483 has revealed visible foreign particles in certain batches of drug product at Catalent’s Bloomington, Indiana facility. The Bloomington plant, which offers fill and finish services and commercial scale production, was handed a Form 483 from the US Drug and Food Administration (FDA) following an inspection at the facility between August 1 and September 1. The 483 detailed that the FDA identified 179 occasions where particles, like black specks, foreign matter, particular matter, and foreign objects…

September 22, 2022