CDMO Avid Bioservices is being acquired by the private equity firms GHO Capital Partners and Ampersand Capital Partners. Avid specializes in manufacturing biologic products for companies at all stages of development.

The post Private Equity Is Picking Up Biologics CDMO Avid Bioservices in $1.1B Acquisition appeared first on MedCity News.

The GMP inspection, conducted by EMA representatives, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging and QC testing and release laboratories.

The GMP inspection, conducted by EMA representatives from April 8-12, 2024, assessed mammalian and microbial drug substance manufacturing facility sections

(United States Fifth Circuit) - Affirmed the voluntary dismissal of a qui tam action that a group of physicians brought against a company operating allergy treatment clinics. Over the company's objection, the physicians sought to voluntarily dismiss their lawsuit with prejudice as to themselves only, so that their decision to quit would not hamstring the government's efforts against the company elsewhere. The district court granted the dismissal motion, and the Fifth Circuit affirmed.

The bioprocessing industry uses recombinant mammalian cell lines to generate therapeutic biologic drugs. To ensure consistent product quality of the therapeutic proteins, it is imperative to have a controlled production process. Regulatory agencies and the biotechnology industry consider cell line "clonal origin" an important aspect of maintaining process control. Demonstration of clonal origin of the cell substrate, or production cell line, has received considerable attention in the past few years, and the industry has improved methods and devised standards to increase the probability and/or assurance of clonal derivation. However, older production cell lines developed before the implementation of these methods, herein referred to as "legacy cell lines," may not meet current regulatory expectations for demonstration of clonal derivation. In this article, the members of the IQ Consortium Working Group on Clonality present our position that the demonstration of process consistency and product comparability of critical quality attributes throughout the development life cycle should be sufficient to approve a license application without additional genetic analysis to support clonal origin, even for legacy cell lines that may not meet current day clonal derivation standards. With this commentary, we discuss advantages and limitations of genetic testing methods to support clonal derivation of legacy cell lines and wish to promote a mutual understanding with the regulatory authorities regarding their optional use during early drug development, subsequent to Investigational New Drug (IND) application and before demonstration of product and process consistency at Biologics License Applications (BLA) submission.

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