CDMO Singota Solutions (Bloomington, Indiana), a leader in Sterile Aseptic Filling, discusses Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.
Michelle Hoover Best Practices, Manufacturing

Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies

Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies Source: Singota Solutions By Ken Chomistek, Singota Solutions Microbial challenge studies are becoming increasingly common as drug products (DP) are being manufactured with different types of active pharmaceutical ingredients (API) than fifteen years ago. Peptides, proteins, monoclonal antibodies, oligonucleotides,…
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