Coupling Experience

  • Half-life extension of recombinant proteins via PEGylation
  • Chemical conjugation of antigenic peptide sequences to carrier proteins.
  • Chemical conjugation of two proteins to form a fusion protein.

Regulatory

All GMP material is produced in accordance to FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.

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GMP Manufacturing Process

  1. First Contact

    Customers contact us with their request and have already identified the linker and type of PEG or peptide sequence to be used.

  2. Quotation

    We define with the customer the best approach and deliver a quotation

  3. Small scale production

    Upon agreement, we start to develop the project at small scale to ensure that the number and location of coupling sites is consistent

  4. GMP batch Manufacturing

    We proceed to the scale up and production of Tox and clinical batches once customers validation received.

Comprehensive GMP BioManufacturing Service