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Let’s Make Drug Substance

Overview: Drug Substance

Althea’s focused expertise and capabilities in current Good Manufacturing Practices (cGMP) production of microbial-based biotherapeutics make us one of the industry’s leaders in microbial fermentation. We offer a broad range of microbial-based cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Althea is a recognized leader in plasmid DNA manufacturing for vaccines and gene therapy products. Althea has demonstrated experience in developing and manufacturing nearly 300 cGMP lots of bulk drug substance and has an impeccable regulatory track record. Our comprehensive, validated equipment has been utilized to fulfill numerous drug substance projects for preclinical and clinical supply. For additional information about Althea’s drug substance manufacturing services including contract cGMP microbial fermentation and biologics manufacturing, please contact us below.

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“During large scale microbial drug substance manufacturing, oftentimes there will be unpredicted factors that fall outside of the project scope and therefore require scale up optimization specific to that project. At Althea, we will go above and beyond to adapt and do whatever is needed to push forward and ultimately have a successful outcome for the client.”
– Dr. Kristin DeFife, VP of Biologics

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