03 May 2011
STERILE manufacturing expert SCM Pharma has announced details of its expanded potent capacity following a major £500,000k investment at its UK-based facility.
The investment will strengthen the company’s unique position in the global CMO market of being able to deliver novel, difficult and dangerous finished drug products. Along with potent products, it can also sterile fill finish C14 radio-labelled compounds to GMP standards, primarily to assist customers carrying out absorption, distribution, metabolism and excretion (ADME) studies at the pre-clinical or clinical trials stage.
The specialist contract manufacturing organisation (CMO) used Interphex Exhibition in New York as the platform to showcase its enhanced capability to the U.S. market, which includes an additional dedicated suite to handle and fill highly potent products such as cytotoxics to cGMP.
The move follows increased demand for potent fill/finish services at SCM Pharma for both clinical trial and commercial supply projects in addition to meeting the scaling-up requirements of other existing pharmaceutical clients.
Neal Wesley, technical director at SCM Pharma, said: “As the business has developed and grown over the past few years, we have always tried to adapt to our clients’ changing and increasing potent product manufacturing requirements.
“We have therefore invested heavily into modifying the facility to ensure we can efficiently deal with a range of different potent projects including small pilot scale, clinical trial progression and the market supply of niche licensed products.”
In addition to the physical introduction of a new 500 sq. ft cleanroom dedicated to making potent products, the team at SCM Pharma has also developed a production technique to handle continuous throughput via isolators to boost its aseptic processing capacity.
“It’s a very exciting time for the business as we now have more flexibility and superior capability to handle multiple potent productions at any one time. This will appeal to many potential customers as it will allow us to meet tight product delivery timelines even on complex projects for our clients,” added Mr Wesley.
The company’s presence at Interphex follows its attendance at AAPS in November, which coincided with the opening of its first US office and appointment of Thomas J. Puskar as Vice President of Business Development in North America.
The investment will strengthen the company’s unique position in the global CMO market of being able to deliver novel, difficult and dangerous finished drug products. Along with potent products, it can also sterile fill finish C14 radio-labelled compounds to GMP standards, primarily to assist customers carrying out absorption, distribution, metabolism and excretion (ADME) studies at the pre-clinical or clinical trials stage.
SCM Pharma offers sterile production services to pharmaceutical, biotech and medical device companies across the world and is able to fill ampoules, vials, syringes, devices and cartridges. It works with several top specialty pharmaceutical companies and many of the big pharma firms.
ENDS
Picture caption: POTENT COMBINATION: SCM Pharma’s Neal Wesley announces expanded potent capacity for the US market
Media contact: Raman Sehgal at SCM Pharma
01661 838 186 / ramans@scm-pharma.com
