My name is Bhanu Dasari, Ph.D. My background is in Analytical Development, which sits on the “Controls” side of CMC, Chemistry, Manufacturing, and Controls. I have worked in biopharmaceutical organizations, including Takeda, developing and qualifying analytical methods that define the quality, potency, and stability of advanced therapeutics.
I created DSDP Analytics to address a recurring problem I encountered in industry. Critical CMC and analytical knowledge is scattered across guidance documents, pharmacopoeias, and regulatory filings, making it difficult to find clear, structured answers that reflect how information is actually presented and evaluated in regulatory submissions.
The content on this site is intentionally structured to mirror how analytical controls and specifications are documented in FDA and EMA CMC submissions. Quality attributes are mapped to analytical procedures, acceptance contexts, and regulatory precedent. The goal is not to prescribe requirements, but to make explicit the analytical decision-making framework that underlies real-world CMC strategies.
This site is a practical resource focused on the methods, specifications, and testing strategies that support the quality of biologics, gene therapies, and cell therapies. Topics are drawn from publicly available sources, including FDA and EMA guidance, USP and Ph. Eur. chapters, and the scientific literature.
While many of the topics reflect areas I have worked on directly, I have also written about others as part of ongoing learning. In my experience, teaching is one of the most effective ways to develop and maintain deep technical understanding.
DSDP Analytics is an independent project and will continue to evolve as new guidance, products, and analytical practices emerge. If you notice gaps or have suggestions, please reach out contact@dsdpanalytics.com.
For vendor-supported technical resources, sponsorship, or selected technical advisory inquiries, see Work with DSDP.