Custom GMP Polymers

Our Drug Delivery Solutions Business Unit coordinates our Custom Polymers activity. Seqens strongly believes in the potential of new cutting-edge technologies.

In the pharmaceutical industry, lipids and polymers are core excipients in the development of drug delivery systems. Lipids and polymers can be used in most dosage forms as support vehicles, solubilizers, permeation enhancers, stabilizers, transfection agents and release rate modifiers.

Such ingredients are particularly relevant for the development of optimized RNA / DNA delivery systems and allow a better bioavailability of drugs or vectorized vaccines. 

Our commitment is to support our customers in reaching the highest requirements in terms of ingredients performances, selectivity and quality. Our Polymers and Lipids CDMO services allow to fine-tune the chemical structure, create opportunities for IP generation, and deliver the products at all stages of the product life cycle.

polymers for pharmaceutical applications

Your global partner for the manufacturing of synthetic polymers

A polymer is any chemical or natural compound obtained by polymerization; a chemical reaction designed to link monomers in order to obtain a macromolecule.

Polymers have multiple pharmaceutical applications in several dosage forms thanks to their chemical and physical properties: 

• Immediate and Controlled release, Film coatings, Solubilizers, Binders, Viscosity modifiers, Microencapsulation, Thickeners, Stabilizers, Permeation enhancer
• Polymers are also perfectly suitable materials used to design high-performance medical devices.

Seqens strongly believes in the potential of new cutting-edge technologies to improve the use and efficiency of existing APIs. To support its customers, Seqens offers a large range of capabilities for custom Drug Delivery excipients, materials for medical devices, 3D printing…​

our custom development and manufacturing offer

cGMP Polymers

• API vectorization and Nanocarriers
• Controlled release applications
• RNA delivery
• Active polymers
• Materials for medical devices

Custom production of chromatographic resins

• For therapeutic proteins and peptides purification
• Resin coating synthesis
• Custom Resin polymerization
• PSD control, sieving
• Custom Resin modification and functionalization (salt inversion, functional group grafting)

Custom Smart Excipients and Medical Materials

to serve our customers markets

a unique offer based on 3 expert r&d centers for drug delivery polymers

completed by a full range of services and a strong expertise in polymers chemistry

• Excellence in organic and polymers chemistry since 1962
• Dedicated polymer workshops units in EU and US
• Full regulatory support (IMPD, DMF Filing)
• Analytical resources and manufacturing units operating according to ICHQ7 and GMP guidelines
• In-house development and scale-up capacities from kilo lab to big industrial scales
• Materials involved on several commercially available formulations or medical devices

our unique technologies’ offer for custom polymers development and manufacturing

Available for Lab scale, GMP kg-Lab scale and GMP commercial supply

chemical reactions types

Seqens has a High-End Pharma Polymer Expertise Center Covering a Complete Range of Polymerization Technology

• RING OPENING POLYMERIZATIONS (ROP)
  • ROP Polymerization with solvent
  • Melt ROP Polymerization (max 12 millions cP)

Such chemistry is involved in: Custom PEG/PPG via Ethylene oxide polymerization (lab and industrial scale), Glycofurol used as a solvent, PLA/PLGA, Polycaprolactone

• RADICAL POLYMERIZATIONS (CONTROLLED AND UNCONTROLLED)

• POLYCONDENSATION

Such chemistry is involved in: Hydrogels, poly-amino acids, Poly fumarate co-polymers, EVA/PVA, Polyurea/urethane…

• CHEMICAL SYNTHESIS AND MODIFICATIONS OF POLYMERS
  • Block copolymer synthesis
  • Sol-Gel Processes
  • Graft Polymerization

• GMP FILTRATION/PURIFICATION

Such chemistry is involved in: Poly(vinylpyridine) modifications, Poly(ethylene glycol) end group modifications, Poly(Lactide-co-glycolide) end group modification, Peg-ylated lipids & linkers synthesis, Gellan gum derivatives, Polysiloxane…

key successes

Seqens’ technical and manufacturing teams have successfully completed countless cGMP medical-grade polymer synthesis projects, developing a strong expertise in leading projects from laboratory scale to GMP commercial supply scale, in the following domains:

• Drug delivery technologies
• Excipients
• Medical devices 510(K)
• Medical-grade coatings
• Therapeutics

recent polymer-related projects

• Acrylate Co-Polymer: Derivatization of an acrylate co-polymer linked with several amino acids, then attached to an API that was used as part of an oral oncology system
• Anti-oxidant Poly(ester) Copolymer: Developing a polyester copolymer with a defined molecular weight and composition that was incorporated into PVA nanoparticles as a delivery mechanism for a free-radical-scavenger in cardiac patients
• Biodegradable Poly(ester) Copolymer: Polycondensation polymerization of modified amino acids with defined molecular weight and copolymer composition for use as a biodegradable antibiotic drug-release substrate in medical implants
• Butadiene-Malaic Anhydride Co-Polymer: cGMP extraction and purification of biodegradable polymer derived from a fermentation process used as a bio adhesive for proprietary drug delivery systems and a coating for oral tablets
• Carbohydrate based polymers: Carboxymethyl cellulose cross-linked with epichlorohydrin and loaded with an API for a drug delivery system
• Cross-linked Divinyl Benzene Co-Polymer: Co-polymerization of divinyl benzene and a derivatized styrene linked to a substrate and a radioactive element for an imaging application
• Emulsion Polymerization: Butyl methacrylate emulsion polymerization requiring extensive physical manipulation to achieve narrow particle size distribution to make it suitable for manufacturing implantable materials
• Bioresorbable custom copolymers and block copolymers of PLGA / PEG / PCL derived from our Expansorb catalog product line
• Poly(vinylpyridine) synthesis and chemical modification for diverse projects including medical devices
• Purification of biosourced polymers (i.e. polysaccharides)
• Poly(amino acids), PBAE, hydrogels, PEG, PPG, PEI, Polyelectrolytes, Poly(oxazolines) synthesis, etc.
• Epoxy-type Oligomer: The mobile phase of solution polymerization cross linking epichlorohydrin with a commercial PEG material used in RNA/DNA drug synthesis
• EVA Polymerization and Processing: cGMP precipitation, extraction, and physical processing of an industrial grade material for an implantable drug delivery system
• Hydroxybutyrate Polymer: cGMP extraction, purification, and physical manipulation of a fermentation-derived biodegradable polymer for post-surgical  wound suturing and webbing
• Methacrylate Co-Polymer: Cryogenic, free radical initiated solution polymerization used in the formulation of a coating for implantable medical devices that included an active ingredient
• Monomer Synthesis: Developed the synthesis and supplied a methylene malonate monomer used downstream in an ionic polymerization for a point-of-use medical device
• Poly(acetal) Copolymer: Condensation polymerization to synthesize a water-insoluble poly(acetal) so that the drug-loaded hydrophobic cores could be suspended in water with a PEG copolymer and used as a cancer drug delivery vector
• Post-Polymerization Modification of Polysaccharides: Modified a commercially available polymer by changing the functional groups of the repeat unit and introducing an active functional moiety to synthesize nanoparticles with a defined size and water content for use as a surgical hemostat
• Suspension Polymerization: Size-controlled synthesis of poly(methacrylate) random copolymers beads to create an enzyme-immobilizing substrate that was as a food contact material to adjust nutrient content