‘‘Creating opportunities means looking where others are not’’
Seqens has developed a portfolio of biodegradable polymers well known under Expansorb® brand and approved as excipients in drug delivery systems (implants, parenteral) of injectable APIs for the controlled and slow release (weeks to months) of the final drug product.
Interview of Karine SALIM, Global Category Manager, on pharmaceutical applications of polymers at Seqens.
Seqens expertise in polymer development
To date, Seqens has three manufacturing sites in Europe (Couterne, Limay, Aramon) and one in Canada (St Jean-sur-Richelieu – Québec) involved in polymers synthesis. Our strong expertise in polymer development and manufacturing enables us to address different markets including lubricants, electronics, cosmetics, photovoltaic and pharma. Two of these sites are listed cGMP (Aramon, Limay) and gather together up to 250 employees who work intensively on active pharmaceutical ingredients (APIs) manufacturing and polymers synthesis for pharma applications including drug delivery and medical device. Our capabilities enable us to work from kg to ton scale, and also to carry out a wide range of polymerization technologies including Ring Opening Polymerisation (R.O.P.), controlled radical polymerisation (RAFT) and condensation polymerisation.
Biopolymers as excipient
Aramon cGMP production site is notably specialized in functional polymers production for drug delivery purpose.
Within this unit, we have developed a portfolio of biodegradable Poly (D,L-lactic acid) (PLA) and poly (D,L-lacticdelivery co-glycolic acid) (PLGA) polymers well known under Expansorb® brand. These polyester polymers are approved as excipients in drug delivery systems (implants, parenteral) of injectable APIs for the controlled and slow release (weeks to months) of the final drug product. Indeed excipients are playing a key role in solubility and bioavailability of a final drug as well as in targeting biodistribution.
In other words, these polymers are typically used to reduce multiple injections, toxicity level and to achieve the desired therapeutic effect. A number of well-known medicines on the market have been using PLGA controlled release since 1988, including Sandostatin LAR (octreotide ), Decapeptyl® (triptorelin ), Zoladex (goserelin ) and Lupron Depot (leuprolide acetate). We leverage our 18 years of expertise in this field and can now provide our customers up to 50 references to support them in tackling formulation challenges encountered at early stage of drug development. In 2016, we entered into an agreement with Merck to expand its excipients portfolio.
Innovation in biopolymers field
To date, Merck is the exclusive, global distributor of the Expansorb® line of biocompatible and biodegradable polymers. It is noteworthy to mention that polymers as carriers for drug delivery systems continuously attracted interest of a numerous scientists who provide an extensive breakthrough in this field. The French Academy of Sciences has recently awarded Dr Julien NICOLAS (research director of CNRS at Institut Galien Paris Sud) with the Seqens Prize 2018 for his outstanding achievement in this field.
PLA are used in medical device applications especially in the preparation of suture or orthopaedic devices. For instance, Inion HEXALON is using PLA to generate biodegradable screw to secure fixation and maintain the stability of bone-tendon-bone grafts. Gradually the screw loses strength during 18-36 weeks and totally resorbed in two to four years.
Seqens’ Expansorb® porfolio is the pillar for the implementation of new biodegradable polymers and continues to expand through the development of several block polymers by our customers: PLA-PEG, PLGA-PEG , diblock, triblock polymers as well as a polycaprolactone (PCL) which will be available soon in the market.
Seqens solutions for pharma needs
Other solutions are offered by Seqens to address pharma needs. For instance, we manufacture a PEKK (Poly-Ether-Ketone-Ketone) polymer, a material that exhibits more resistance and is useful for long-term implantable human devices with quite unlimited life cycle such as orthopedics, neurological, dental, spinal and cardiovascular implants but also in PEKK-based 3D-printed bones. Our capabilities and our expertise also enable us to manufacture resins under GMP aiming at purifying protein like insulin. Our polymers teams are currently working on the development of semi-conductive polymer-based sensors for biomedical applications and target especially skin biosensor system, which play nowadays a large and growing role in medical diagnostics and patient monitoring.
In addition, we deliver to our clients the best-in-class custom polymer services as well as full regulatory support (IMPD, DMF filing) in their project.
Karine SALIM, PhD
Global Category Manager
Drug Delivery & Medical Materials
Custom Synthesis & Pharma Chemicals