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SCM Pharma Limited Release: CMO To Unveil Blank Canvas at ICSE
10/2/2013 10:42:54 AM
October 2013 -- UK-based SCM Pharma will use ICSE at CPhI in Frankfurt as a platform to offer pharmaceutical companies across the world the opportunity to design their clinical and contract manufacturing projects from a ‘blank canvas’ of cleanroom space.
In contrast to contract manufacturing organisations (CMOs) that offer fixed equipment capabilities, the sterile filling specialist is inviting drug developers and licensed product owners the opportunity to utilise dedicated space at its new 2400m² (26k sq. ft.) site to design a process around their specific product manufacturing needs.
The bold move from the CMO comes after its second pharmaceutical contract manufacturing facility was given the go ahead for production following a successful inspection from the MHRA this summer.
Dianne Sharp, managing director at SCM Pharma, said: “Our approach at the event this year is to offer our new space to organisations that have a more complex process and sterile product manufacturing need that doesn’t fit into the traditional CMO mould.
“Although we are able to provide more standard ampoule, vial and syringe filing under aseptic conditions, we are also able to work with companies in developeing novel processes around unusual dosage forms, smaller fill volumes and high containement levels.
“We’ve always been flexible in our approach as an organisation but our new facility has given us the capability to literally offer a blank canvas of cleanroom space along with an expert team to clients that we believe is unparalleled in the sterile manufacturing arena.”
Based in North-East England, SCM Pharma’s new site houses technology for aseptic processing and terminal sterilisation capabilities. It is able to handle highly potent, flammable and toxic products along with controlled drugs.
The CMO specialises in the sterile manufacturing of drug products and most of its contract filling projects assist companies requiring products for clinical trials or licensed drugs needed in niche commercial markets such as orphan drugs.
With space for late stage clinical and commercial scale projects, the new site, which includes a potent suite, dedicated commercial suite and Grade C/D rooms, significantly increases SCM Pharma’s current and future capability and capacity.
The company’s nearby HQ is dedicated to development and clinical trial supply projects that involve investigational medicinal products and also supports ADME studies requiring the supply of Carbon-14 radiolabeled compounds.
“We are now able to provide product for first-in-man studies, clinical trial supplies, larger batch sizes to support Phase IIa/IIb trials and commercial volumes, so we encourage firms with more complex sterile fill/finish needs to pay us a visit at ICSE,” added Dianne,
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