The UK-based contract manufacturing organisation (CMO) is supporting Molteni Therapeutics with product supply of an aseptically manufactured gel for a Phase II trial after a successful initial collaboration for Phase I trials.

The complex production process involves the thermal sterilisation of a bulk solution before being mixed with the API and aseptically filled using isolator technology into small volume vials. The product is then labelled, randomised, packed and released to the clinical trial sites from the CMO’s MHRA-licensed facility.

Molteni Therapeutics is a Molteni Farmaceutici spin-off focused on the discovery and development of novel antimicrobial therapeutics. Its innovative lead therapeutic being manufactured by SCM Pharma is being developed for the treatment of infected diabetic foot ulcers (DFUs), which is the leading cause of lower limb amputation in the western world.

Giacomo Chiti, head of analysis and bioanalysis at Molteni Therapeutics, said: "SCM Pharma demonstrated strong technical knowledge during the development stage of our project and have since shown their expertise in production and packing this investigational medicinal product.

"Their introduction of in-house sterility testing along with the team’s flexible approach to help meet our needs made them the ideal choice to support our scaled-up Phase II clinical trial supply needs."

SCM Pharma commands a distinctive position in the global CMO market with its ability to sterile fill finish C14 radiolabeled products to GMP standards and manufacture potent products. The company fills liquids, gels and powders into various final dosage forms including ampoules, vials, syringes, devices and cartridges.

Neal Wesley, technical director at SCM Pharma, said: "We are very pleased to be strengthening our relationship with the team at Molteni Therapeutics by partnering with them on the next phase of their innovative project.

"Our technical expertise, manufacturing capabilities and in-house testing facilities have played an important role in providing one all-encompassing facility to support the progression of their lead candidate through clinical trials.

"The aseptic manufacture of a gel product into a vial is certainly not an ordinary project but is one that fits perfectly with our position as the world’s leading CMO when it comes to delivering novel and difficult sterile drug products," added Neal.

Molteni Therapeutics is a product-driven biopharmaceutical company dedicated to the development of novel antimicrobial drugs based on the PDT platform to meet unmet medical needs. The company targets the therapeutic areas of wound-infection, wound healing and periodontal disease.

The Florence-based company is one of a number of specialty pharmaceutical firms across Europe now working with sterile manufacturing specialist SCM Pharma on either a clinical trial project or the commercial supply of niche licensed medicines.

The CMO was recently awarded a commercial supply contract by ProStrakan and has since expanded its capacity to fill highly potent products such as cytotoxics following a major investment at its UK-based facility.

Along with a client portfolio featuring several specialty pharmaceutical companies, SCM Pharma has now worked with a third of top ten big pharma on various product indications across a number of therapeutic areas.

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