Manufacturing Advice for Optimal Drug Development
June 2, 2009 at 7:30 am EST | Tags: Advertisers
BioPharm Process Associates (BPPA) is a premier cGMP manufacturing and CMC advisory firm that can accelerate your product’s development and approval.
BPPA can provide your firm with crucial guidance and industrial expertise in the areas of bioprocess development, scale-up, process design, manufacturing, quality assurance, validation and regulatory compliance. BPPA also works to identify and analyze the ideal partnerships for your product’s unique needs, all while evaluating manufacturing alternatives, performing any needed due diligence and developing useful quantitative models of proprietary biopharmaceutical manufacturing operations.
How have clients benefited from BPPA?
For a US-based firm’s monoclonal antibody, BPPA executed technology transfer and facilitated quality system integration with a European-based bulk drug substance CMO, as well as coordinated technology transfer to a US-based final drug product CMO for production of Phase II trial supplies.
BPPA further assisted the same client with the identification of a second final drug product CMO for the production of Phase III and commercial supplies.
To learn more about how BioPharm Process Associates can help your firm, please visit www.biopharmprocess.com. Don’t forget to mention you found them on IguanaBio!
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