Welcome To Biosynthesis - Custom Peptide

Bio-Synthesis Awarded NIH Grant to Develop Synergistic Adjuvants that Stimulate both Innate and Adaptive Immunities

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Bio-Synthesis, Inc. Launches Peptide Library Generation Tools Software

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To provide you with quality peptide product for the results you can trust...

GMP

Bio-Synthesis has been providing peptide synthesis since 1984. Our unique and comprehensive experience has enable us in providing peptides from discovery research project to highly regulated multiple kilogram per batch GMP peptides. Our goal is to be your single peptide partner at every stage in the peptide drug development continuum from design of peptide libraries, through to GMP manufacturing of active pharmaceutical ingredients (APIs) and commercialization. Our consistency, viability, and delivery are guaranteed.

Your Success is Our Business

Our commitment to customer satisfaction is at the heart of our corporate philosophy. That's why our clients find so many advantages in working with us, including:

	Extensive expertise in peptide chemistry
	FDA-compliant GMP facilities
	Flexible strategies for development and production to meet your needs
	A commitment to finding the best project execution
	Sensitivity to time demands

	Cost-effective full-scale manufacture
	Client-dedicated project management teams
	Comprehensive regulatory support
	Regulatory Agencies Rapport
	Long-term stability for security of supply

GMP Compliance & Regulatory Packages

	FDA-compliant cGMP facilities
	Chemistry, Manufacturing and Controls (CMC) Documentation in Common Technical Document (CTD) format for INDs
	Drug Master File (DMF) Compilation
	Representation at the FDA and/or other Regulatory Authorities

Quality Control and Assurance

At BSI's peptide Laboratories, quality processes and management are paramount at every step of development and production to ensure full cGMP compliance guarnateed. BSI has developed and maintained a robust quality assurance system covering all aspects required for the cGMP production of peptide API’s.

Production Process

Once a manufacturing process has been validated and approved, and no additional GMP Custom Development is required, the production of the peptide becomes one of contract manufacturing. Depending on the requirements for the peptide, the process may be transferred to a manufacturing suite dedicated specifically to the peptide API (active pharmaceutical ingredient).

Development Pipelines

From discovery scale non-GMP to GMP production, our facilities has produced peptides in gram to multiple kilogram quantities per batch.

We can support your custom project from start to finish with gram to multi-kilogram quantities of even the most complex peptides.