Custom Synthesis

We are experts in the Solid Phase Synthesis
of API New Chemical Entities

If you work in the development of new Active Pharmaceutical Ingredients BCN Peptides can assist you in your peptide project. Our company has experience in manufacturing peptides for all clinical phases, from pre-clinical to phase I, II, III and commercial stage.

BCN Peptides is an industrial manufacturer with the capacity to produce up to multi-kg bulk commercial quantities of pharmaceutical peptides. Our new facility located in Sant Quinti de Mediona offers 2.500 sqm of production area and laboratories dedicated to the GMP manufacture and control of peptides. This facility has been specially designed by BCN Peptides applying all our know-how in Solid Phase Peptide Synthesis and has been equipped with the most advanced technology.

Our Key Technologies are:

  • Solid Phase Synthesis
  • HPLC Purification
  • Lyophilisation
  • Sterile Peptides

We have a strong R+D department involved in the synthetic development. We have experience in the use of different chemical peptide synthesis technologies as Sequential synthesis, Convergent or Hybrid Synthesis (Solid- and Liquid- phase combined) and Chemical ligation. We are familiar with the use of unnatural amino acids, pseudo-prolines, pegylation and different oxidation, deprotection and purification procedures. We use different peptide synthesis systems, as manual or automated, both for small and large scale synthesis of peptides and we are specialists in long sequences and cyclic peptides.

BCN Peptides has experienced Quality assurance and Regulatory Affairs departments, which guarantee comprehensive quality services and support in all phases of a drug’s life cycle. We will ensure that your NCE can be compiled and filed in full compliance with the most strict international standards.

Our facility includes a classified (from grade D to grade A) area with 8 independent rooms for preparative HPLC, with columns between 10 and 20 cm diameter (and analytical in process control laboratory), and 9 independent rooms for the Lyophilisation of the final API Peptide. We also have dedicated area to the manufacture of Sterile API Peptides, including Lyophilization and packaging under sterile conditions.

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Where can BCN Peptides assist your peptide project?

custom-synthesis-diagram

BCN Peptides’ range of activities:

  • Synthetic Development
    • R&D (Route development)
    • Scaling up
    • Validation Batches
    • Process Validation
  • Analytical Development
    • Characterization
    • Working Standard Preparation
    • Establishment of Specifications
    • Analytical Method set up and Validation
  • ICH Stability Study
  • IMPD/IND and CTD/DMF preparation
  • Regulatory Support in front of US FDA/EMEA
  • Commercial Manufacturing
  • Analysis of pharmaceutical final product

 

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