cGMP Medical Grade Polymers

Seqens, part of SEQENS CDMO technical and manufacturing teams have executed countless cGMP Polymer related synthesis projects.

The applications for Medical Grade polymer projects we have engaged in have included medical devices (510k), drug delivery technologies, therapeutics, excipients, and medical grade coatings. All of these projects begin in our laboratories enabling our teams to not only improve many of our polymerization processes, but also to adopt the latest analytical techniques to support their development. Seqens also has the capacity to produce all of our cGMP polymers in our Newburyport facility from kilo’s to tons.


Polymers for pharmaceutical applications

  • Custom drug delivery system development: polymer-drug delivery system such as poly acrylates/methacrylate copolymers, poly oxazolines.
  • Biomedical implants: Custom production of poly fumarate co-polymers, EVA/PVA, polyurea/urethane etc.
  • Custom synthesis of biomedical application related hydrogels.
  • Custom manufacturing of poly-amino acids.  
  • Custom GMP polymers/oligomers.

Key services

  • Material/polymer consultation:
    Offer customized solution targeting specific polymers. Offer evaluation on existing synthetic route. Propose optimized/new synthetic route. Evaluate existing analytical methods. Propose optimized/new analytical methods.
  • Manufacturing:
    Offer synthesis of pharmaceutical grade polymers targeting drug delivery, tissue engineering and medical device related applications.  Perform synthesis of polymer from 100 mg scale to multi-kilo grams. Manufacture both GLP and cGMP polymers.
  • Research &Development:  
    • Experienced in Synthesis of polymer and poly amino acids systems;
    • Experienced in biomedical polymers, hydrogels, drug delivery system.
    • Experienced in specific polymerization techniques: Polycondensation polymerization, radical polymerization (uncontrolled and controlled), ring opening polymerization.
    • Experienced in polymer related analytical testing support: GPC, DSC, TGA, melt index, tap density, FT-IR, solid state NMR
  • Analytical support:
    Offer different polymer testing techniques: GPC/SEC, NMR, FT-IR, DSC, TGA, Melt index, tap density. Offer method development service related to polymer characterization.