Custom Peptide Synthesis Company Custom Antibody Synthesis
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Bio-Synthesis Awarded NIH Grant to Develop Synergistic Adjuvants that Stimulate both Innate and Adaptive Immunities 
Special voucher reward with new publication... 
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

top GMP Compliance & Regulatory Packages top
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
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top Quality Control and Assurance top
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.
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top Production Process top
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).
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top Development Pipelines top

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.

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