Catalent can now handle more highly toxic oral delivery products after expanding its controlled drug release development tech at the Schorndorf plant in Germany.
The investment – an unnamed but “significant” amount – includes research and development (R&D) and commercial scale fluid bed technology, and OptiMelt hot melt extrusion equipment.
The firm has also ramped up the plant’s cGMP (current good manufacturing practice) compliance, allowing it to provide clients with OEB (occupational exposure band) class 3 products – offerings requiring more stringent safety methods for drug handlers.
Ian Muir, president of the company’s modified release technology business, said the move follows another recent delivery tech investment at Catalent’s site in Kentucky, US.
He said that together, the expansions mean the firm is now better equipped to provide the most difficult bioavailability, controlled release or targeted delivery profile challenges.
Patheon has teamed up with Procaps to launch a new soft-gel product development and manufacturing service.
Under the agreement, Patheon will market the new technology – named P-Gels – soft gel as well as Procaps’ manufacturing capabilities in North America, Europe and Asia.
Procaps currently has capacity to produce up to nine billion capsules per year.
Michael Lytton, executive VP of corporate development for Patheon said: “Soft gel oral drug delivery offers many advantages to some of the more challenging compounds being developed by the pharmaceutical industry today and the collaboration with Procaps builds on Patheon's successful SoluPath(TM) solution set for compounds with solubility challenges.”
CEO Jim Mullen said the deal is in line with Patheon’s recently announced strategy to strengthen its core offering, and adds to its other dosage forms, which includes parenteral, solid and liquid technologies.
Frontage Laboratories’ Exton facility in Pennsylvania, US, has received the FDA thumbs up to keep its certification as commercial testing labs.
The results mark the fourth consecutive year that the CMC (chemistry, manufacturing and controls) plant has received no citations during the US Food and Drug Administration’s (FDA) annual inspection.
The division also provides pharmaceutical API development and manufacturing of clinical trial materials including sterile, oral solid, topical, and high potent products.
Of the results, Song Li, Frontage’s founder and CEO, said: “We make it a priority to build in quality from start to finish for every project.”
In other regulatory news, AMPAC Fine Chemicals has been granted registration as a manufacturer of controlled substances by the US Drug Enforcement Agency (DEA).
The firm has been developing narcotics, Schedule II controlled substances, under a researcher’s license from the DEA since 2008 within a high security area of its Rancho Cordova, California, facilities.
Recent upgrades, as well as a commercial agreement with an un-named large pharma company, now allow the firm to include commercial scale manufacturing of Schedule II controlled substances.
The investments means the facility can now safely run hydrogenations and hazardous chemical processes, while containing reactants and products with low operator exposure.
“This major milestone enhances our position as a fine chemical supplier with world-class cGMP manufacturing capabilities in the United States,” said Aslam Malik, company president.