GMP Production

For over 10 years, piCHEM has provided synthetic peptides for various applications worldwide. Given our extensive experience in synthesizing peptides for therapeutic and diagnostic research applications, we have upgraded our services to GMP production since 2002. piCHEM is able to assist you with your project from the early stages of pharmaceutical drug development over clinical phases I-III to registered generic API´s including method development and validation.

piCHEM provides thermal stability studies for long term and accelerated storage as well as stress testing according to ICH-guidelines.

The Austrian national health authorities have audited and approved our facilities. We can offer peptide synthesis according to GMP with the following techniques:

 

  • Conventional synthesis (liquid phase)
    Up to
    10 amino acid residues in 500 g quantities.
    Also available for chromogenic and fluorogenic substrates.
  • Solid phase synthesis (SPPS)
    Up to 35 amino acid residues in 100 g quantities.

 

The manufacturing process is strictly controlled by a full set of SOPs (Standard Operating Procedures) and thoroughly documented by our qualified and fully trained staff members. Raw materials are purchased from approved vendors and carefully evaluated by our quality control team prior to use. Every batch of product is verified, providing an accurate and lot-specific certificate of analysis.

 

To place a GMP quote request, please send us a fax +43-316-681711-4,  an email to This email address is being protected from spambots. You need JavaScript enabled to view it. This e-mail address is being protected from spambots. You need JavaScript enabled to view it  or you can visit our online shop!

 

If you need the actual GMP certificates, please download the following documents:
GMP_Certificate_8045.pdf          

GMP_Certificate_8074.pdf