AmbioPharm

Chris Bai is the CEO of AmbioPharm. To contact Chris Bai email at [email protected].

The decision makers in AmbioPharm are Brant Zell, Chris Bai, Dominik Bernhagen, etc. Click to Find AmbioPharm decision makers emails.

AmbioPharm specializes in a wide range of services as a Contract Development and Manufacturing Organization (CDMO) for peptides. Their offerings include process development, GMP peptide manufacturing, regulatory support, and analytical methods support. They cater to various industries, including pharmaceuticals, cosmetics, and agriculture, providing custom peptide synthesis, generic peptides, and peptide active pharmaceutical ingredients (APIs) for clinical and preclinical applications.

GMP, or Good Manufacturing Practice, is crucial in the pharmaceutical industry to ensure that products are consistently produced and controlled according to quality standards. At AmbioPharm, GMP compliance guarantees that their peptide manufacturing processes meet regulatory requirements, ensuring the safety, efficacy, and quality of peptide-based APIs. This is particularly important for clients developing peptides for clinical trials and commercial use.

Yes, AmbioPharm provides comprehensive regulatory support for peptide products. Their team is experienced in navigating the complex regulatory landscape, helping clients prepare the necessary documentation for submissions to regulatory agencies. This includes guidance on compliance with FDA regulations and other international standards, ensuring that clients can successfully bring their peptide products to market.

AmbioPharm is capable of manufacturing a wide variety of peptides, including custom peptides, generic peptides, and peptide APIs for new chemical entities (NCEs). They also produce cosmetic peptides and agricultural peptides. Their expertise spans across different applications, from clinical and preclinical manufacturing to commercial peptide production, allowing them to meet diverse client needs.

AmbioPharm employs rigorous quality control measures throughout the peptide manufacturing process. This includes the use of validated analytical methods to test the purity, identity, and potency of the peptides produced. Their adherence to GMP guidelines and continuous monitoring of manufacturing processes further ensure that the peptides meet the highest quality standards required for pharmaceutical and other applications.

AmbioPharm serves a variety of industries, including pharmaceuticals, cosmetics, and agriculture. They provide tailored peptide solutions for each sector, whether it’s developing peptide APIs for drug development, creating cosmetic peptides for skincare products, or synthesizing agricultural peptides for crop protection. Their broad expertise allows them to support clients across multiple fields with specialized peptide manufacturing and development services.