New approvals and contracts at CMOs

Related tags Clinical trial Pharmacology

New approvals and contracts at CMOs presents a round up the latest developments in the contract manufacturing sector – with news from Cambrex, Florida Biologix, SCM Pharma, Recipharm and OctoPlus.

US contractor Cambrex​ has been cleared to produce the opioid analgesics sufentanil and sufentanil citrate at its facility in Charles City, Iowa.

The firm - which produces a range of active pharmaceutical ingredients (APIs), drug intermediates and delivery devices - said it will start manufacture later this month.

Kurt Kiewel – director of chemical development at the Iowa facility – said the addition of sufentanil and sufentanil citrate production capacity was a natural extension of Cambrex’ manufacturing capabilities.

The development and validation of Sufentanil and Sufentanil Citrate was a natural extension of Cambrex’ high-potency and controlled substance manufacturing capabilities at our Charles City facility.

The process was based on our patented technology which allows straightforward access to all of the Fentanyl derivatives​.”

In other US news Florida Biologix​ has received GMP approval for drug manufacturing at its facility in Alachua. The firm can now perform fill and finish for biologic products for Phase I/II clinical trials in Europe in batches of up to 4,000 vials.

Company associate director Joyce Francis said the approval – coupled with a number of new technologies added at the facility – “Support our multi-year production contracts. As our business grows, we continue to make investments to improve our state-of-the-art facility and overall capabilities​.”

CDMO Recipharm​ has helped PledPharma to restart a trial of its candidate heart attack treatment mangafodipir.

Patient recruitment in the mangafodipir trial – named MANAMI - halted earlier this year after supplies of the drug ran out.

Following an approach by PledPharma, Recipharm has worked together with PledPharma to ansure an approval from the regulatory body allowing the continuation of the study.

Maria Lundberg General Manager of Recipharm Pharmaceutical Development AB, commenting on the new approval, said: “We are pleased to contribute to the continuation of this important clinical trial. After being contacted by PledPharma, both companies worked very hard together to get the clinical trial material approved as fast as possible.​ “

SCM Pharma​ will develop and produce trial supplies a hypotension treatment for premature babies being trialled by BrePCo BioPharma.

SCM will make batches for eight clinical trial sites across Canada and Europe and will scale-up to commercial production if the drug – an inotropic agent currently cleared for use in adults with low blood pressure - is approved by regulators.

The Northumberland, UK-based contractor has already manufactured engineering batches and will commence work on a stability study with process validation in the next few weeks.

Dianne Sharp, managing director at SCM Pharma, said: “With our established vial filling capability, we will be working closely with the BrePco team to fast track their project as quickly as possible to help them meet their clinical trial deadlines​.”

Finally this week Netherlands-headquartered contractor OctoPlus​ said it has landed a formulation development and manufacturing contract with Ferring Pharmaceuticals.

Further terms of the projects were not disclosed, although OctoPlus did predict that it will make a material contribution to its 2012 revenues.

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