Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

MHRA Approval for CDMO’s Commercial Facility

Published: Thursday, June 20, 2013
Last Updated: Thursday, June 20, 2013
Bookmark and Share
To supply licensed commercial products and aid clinical projects.

SCM Pharma’s new £6m ($10m) pharmaceutical contract manufacturing facility has been given the go ahead for commercial production following a successful inspection from the Medicines and Healthcare products Regulatory Agency (MHRA).

The UK-based contract development and manufacturing organization (CDMO) will use its new 26k sq. ft. site for the supply of licensed commercial products and to complement its nearby clinical manufacturing facility for projects requiring scaled-up clinical trial supply quantities.

Based in North-East England, the contract drug manufacturing site is able to handle highly potent, flammable and toxic products along with controlled drugs.

It houses technology for aseptic processing and terminal sterilization capabilities and is equipped for ampoule filling, vial filling and syringe filling.

Dianne Sharp, managing director at SCM Pharma, said: “The official MHRA approval of our new facility is a huge landmark in the history of our company and heralds in a new era for our team.

“I’d like to thank all those involved in the planning, design and construction of SCM Newburn as the end result is what I believe to be one of the finest contract manufacturing facility of its type in Europe.

Sharp continued, “We are planning an event to officially open the doors this summer before Newburn becomes a hub for the production and supply of licensed drug products to help patients across the world.”

Independently-owned, SCM Pharma specializes in the sterile manufacturing of drug products that require high containment. Most of the CDMO’s contract filling projects assist companies requiring products for clinical trials or licensed drugs needed in niche commercial markets such as orphan drugs.

With commercial scale cleanrooms, which include a potent suite, dedicated commercial suite and Grade C/D rooms, the new site massively increases SCM Pharma’s current and future capability and capacity.

The site includes a range of packaging and labelling areas, temperature controlled warehousing, raw materials and engineering preparation, visual inspection and leak testing.

A dedicated, enclosed cleanroom suite has also been built that houses an automated syringe filling and packaging line with full track and trace capability.

The company’s HQ is dedicated to development and clinical trial supply projects that involve investigational medicinal products and also supports ADME studies requiring the supply of C-14 radiolabeled compounds.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More Than 4,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

MHRA Approves New SCM Pharma Commercial Facility
SCM Pharma’s new £6m ($10m) pharmaceutical contract manufacturing facility has been given the go ahead.
Thursday, June 20, 2013
SCM to Support BTG NDA
Will provide scale up for Varisolve launch.
Friday, April 26, 2013
Vial Filling Boost at SCM
UK-based CDMO invests over £500k in new vial filling equipment.
Thursday, March 15, 2012
SCM to Deliver Vial Filling Project
BrePco selects CDMO to initially produce clinical batches for eight clinical trial sites.
Friday, February 10, 2012
Scientific News
Open Source Seed Initiative – A Welcome Boost to Global Crop Breeding
A team of plant breeders, farmers, non-profit agencies, seed advocates, and policymakers have created the Open Source Seed Initiative.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Anthrax Proteins Might Help Treat Cancerous Tumors
Studies in mice reveal novel treatment regimen.
New Cancer Drug Target Found in Dual-Function Protein
Findings from a study from TSRI have shown that targeting a protein called GlyRS might help to halt cancer growth.
Key to Chronic Fatigue Syndrome is in Your Gut, Not Head
Researchers report they have identified biological markers of the disease in gut bacteria and inflammatory microbial agents in the blood.
HIV Structure Stabilized
Findings represent ‘big accomplishment’ in biomedical engineering and design.
Four Newly-Identified Genes Could Improve Rice
A Japanese research team have applied a method used in human genetic analysis to rice and rapidly discovered four new genes that are potentially significant for agriculture. These findings could influence crop breeding and help combat food shortages caused by a growing population.
New Cancer Drug Target in Dual-Function Protein
Scientists at The Scripps Research Institute (TSRI) have identified a protein that launches cancer growth and appears to contribute to higher mortality in breast cancer patients.
Antibodies To Dengue May Alter Course Of Zika Virus Infection
Scientists at Emory Vaccine Center, in collaboration with investigators from Thailand, have found that people infected with dengue virus develop antibodies that cross-react with Zika virus.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!