Polypeptide APIs R&D (Non-GMP)
With a dedicated R&D Polypeptide APIs synthesis team of nearly 100 chemists and 20,000 square feet of facility space, Shengnuo offers a wide variety of non-GMP manufacturing options. We have the ability to make almost any custom sequence or peptide library that our customers can design.
Having more than a decade of experience producing Polypeptide APIs means that our chemists can produce Polypeptide APIs that other companies cannot. Also, our staff can provide critical technical feedback both before, and during a project, to ensure maximal efficiency.
Examples of available modifications for non-GMP projects
|1||FRET & TR-FRET peptides|
|2||Fluorescent dye labelled peptides: FAM, TAMRA, Cy3, Cy5, etc.|
|7||Phosphorylation – Tyr, Ser, Thr|
|8||Acetylation & Methylation – Lys, Arg|
|10||KLH, BSA conjugation|
|11||C-terminal modifications: Aldehyde, CMK, FMK, Alcohol, etc.|
|12||Any other commercially available options|
Polypeptide APIs Library Experts
Polypeptide APIs libraries are an area of expertise for our production staff. Due to our large capacity and high numbers of elite chemists, our staff can produce a wide variety of peptide libraries at incredible prices.
Libraries can range in sequence length, purity, complexity and even contain modifications (amidation, dyes, labels, etc.).
We can even perform custom packaging (aliquots, special vials, labels, etc.), which saves our customers time post-production. Contact our sales team to learn more about how we can help meet your peptide library needs.
Polypeptide APIs cGMP Production
High quality Polypeptide APIs GMP synthesis has been a primary focus of Shengnuo Peptide since the company’s founding in 2001. During our more than 10 years of operation, Shengnuo has become a dominant solid-phase peptide manufacturer in the domestic Chinese market.
This overwhelming success has led to the founding of our US-based sales team, which will bring our quality and expertise to the international marketplace.
Shengnuo’s Polypeptide APIs GMP production group is made up of over 100 of the best chemists in China. These chemists are dedicated solely to GMP production and work in our more than 60,000 square foot cGMP facility.
State-of-the-art instruments and infrastructure mean that our customers receive the highest possible quality and regulatory support. Customers select Shengnuo as their GMP manufacturing partner because of our intimate knowledge of regulatory guidelines in both China and the USA.
Shengnuo has consistently undergone regulatory audits from the Chinese FDA (sFDA) since 2008 and, as of 2012, we passed a US FDA audit with no Form 483 observations. Having a firm grasp of the necessary quality and documentation rules in both China and the USA, makes Shengnuo an ideal global peptide partner.
A major benefit to working with Shengnuo Polypeptide APIs for GMP projects is our ability to handle all parts of the GMP process: large single batch capacity, all necessary testing in-house (stability, microbiology, endotoxin, LC/MS, etc.), QC, QA and RA. Also, our regulatory team has assisted in several DMF’s (drug master files), CMC packages and drug registries.
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