Singota Solutions (Bloomington, Indiana CDMO) discusses Early Stage Drug Development: Navigating the Trends That Shape Tomorrow's Therapies. Singota specializes in injectable drug development.
Sitav Elturan Development, Industry, Innovation

Early Stage Drug Development: Navigating the Trends That Shape Tomorrow’s Therapies

The early stages of drug development are the crucible where science, strategy, and innovation converge. In this phase, decisions carry outsized weight - shaping not just the technical viability of a molecule but its clinical trajectory, regulatory positioning, and ultimate market potential. As the industry navigates shifting economic conditions, evolving…
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IND Submission DMO 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

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 (IND Submission). Peptides, proteins, monoclonal antibodies, oligonucleotides, and biosimilars are more common; manufacturing no longer places an emphasis on small molecules. These new APIs…
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