API Manufacturing

cGMP Medical Grade Polymers

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

API Manufacturing and cGMP Polymer Manufacturing

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. PCI 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:  
  1. Experienced in Synthesis of polymer and poly amino acids systems;
  2. Experienced in biomedical polymers, hydrogels, drug delivery system.
  3. Experienced in specific polymerization techniques: Polycondensation polymerization, radical polymerization (uncontrolled and controlled), ring opening polymerization.
  4. 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.

Our recent polymer-related projects include:

Suspension Polymerization

  • Size-controlled synthesis of poly(methacrylate) random copolymers beads then used as an enzyme-immobilizing substrate
  • Used as a food contact material to adjust nutrient content

Biodegradable Poly(ester) Copolymer

  • Condensation of polymerization of modified amino acids polymers with defined molecular weight and copolymer composition
  • Used as a biodegradable antibiotic drug-release substrate in medical implants

Post-Polymerization Modification of Polysaccharides

  • A commercially available polymer is modified by changing the functional groups of the repeat unit and introducing an active functional moiety. The modified polymer is then used in the formation of nanoparticles of controlled size and water content.
  • Used as a Hemostat in surgical applications

Anti-oxidant Poly(ester) Copolymer

  • A polyester copolymer was developed with targeted molecular weight and composition. The polymer was then incorporated into PVA nanoparticles as a delivery mechanism
  • Used as a free-radical-scavenger in cardiac patients

Poly(acetal) Copolymer

  • A water-insoluble poly(acetal) is formed by condensation polymerization. The drug-loaded hydrophobic cores are suspended in water using a PEG copolymer
  • Used as an drug delivery vector in cancer therapy

Epoxy-type Oligomer

  • Solution polymerization cross linking epichlorohydrin with a commercial PEG material
  • Mobile phase used in RNA/DNA drug synthesis

Hydroxybutyrate Polymer

  • cGMP extraction, purification, and physical manipulation of a fermentation-derived biodegradable polymer
  • Used post-surgically for wound suturing and webbing

Cross-linked Divinyl Benzene Co-Polymer

  • Co-polymerization of divinyl benzene and a derivatized styrene. The co-polymer was then linked to a substrate
  • Used in an imaging application after the addition of a radioactive element

Methacrylate Co-Polymer

  • Cryogenic, free radical initiated solution polymerization
  • Used in the formulation of a coating with an active ingredient for implantable medical devices

EVA Polymerization and Processing

  • cGMP precipitation, extraction, and physical processing of an industrial grade material
  • Used as an implantable drug delivery system

Butadiene-Malaic Anhydride Co-Polymer

  • cGMP extraction and purification of biodegradable polymer derived from a fermentation process
  • Used as a bioadhesive for proprietary drug delivery systems and the coating of oral tablets

Carbohydrate based polymers

  • Carboxymethyl cellulose cross-linked with epichlorohydrin
  • Used for loading with an API for a drug delivery system

Emulsion Polymerization

  • Butyl Methacrylate emulsion polymerization that required extensive physical manipulation to achieve a narrow particle size distribution
  • Used in the manufacture of implantable materials

Monomer Synthesis

  • Developed the synthesis and supplied a Methylene Malonate monomer
  • Used downstream in an ionic polymerization in a point-of-use medical device

Acrylate Co-Polymer

  • Derivatization of an acrylate co-polymer linked with several amino acids, then attached to an API
  • Used as part of an oral oncology system