Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Almac Doubles Drug Product Development Capacity with a New Non-GMP Facility

Published: Tuesday, January 15, 2013
Last Updated: Monday, January 14, 2013
Bookmark and Share
New facility offers clients greater flexibility and speed in formulation and process development.

Almac has announced the expansion of our drug product Pharmaceutical Development services with the creation of a new non-GMP formulation development facility and two new analytical laboratories at our UK headquarters in Craigavon.

The new facilities double our current pharmaceutical development capacity allowing us to meet the growing demand for our services, both from existing and new clients.

The new non-GMP formulation development facility offers clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the GMP environment at an appropriate stage.

Although the new facility will be dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs.

Whereas, the existing GMP facilities can support drug product manufacturing from phase I up to registration and commercial scale, the new non-GMP facility will primarily focus on lab-scale experiments, with batch sizes ranging from <1kg up to an expected maximum of 15 kg scale for most technologies.

John McQuaid, VP of Technical Operations explains “Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities. Duplicating equipment trains means that we can conduct non-GMP work efficiently and then transfer rapidly to GMP manufacturing for clinical and registration batches. We are finding that demand for non-GMP process development work has increased as clients seek to better understand their processes in line with the principles of QbD. This type of work also creates large sample sets for analytical testing and multiple stability studies which is why it was also important that we doubled our analytical capacity in parallel.”


Further Information
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 2,500+ scientific posters on ePosters
  • More than 3,700+ 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

Almac Group Expands Asia Pacific Presence
Company opens new regional headquarters and clinical trial supply facility in Singapore.
Thursday, July 16, 2015
Novozymes Biopharma Announces Collaboration with Almac
Combined service offers drug development companies efficiencies in time and resource.
Tuesday, October 22, 2013
Almac Expands US & UK Commercial Facilities
Investments of over $20m enhance Almac’s commercial facilities on both sides of the Atlantic.
Tuesday, October 22, 2013
Almac Announces Further Expansion and 229 New Jobs
Dual expansion with completion of a new non-GMP drug development facility.
Monday, June 17, 2013
Almac Launches US Commercial Packaging Operations in Audubon
Company also announces launch of new client partnership.
Monday, May 20, 2013
Almac Receives FDA Inspection Approval
Successful inspection of analytical facilities at Almac’s Craigavon Headquarters, Northern Ireland from the US FDA.
Thursday, February 21, 2013
Charlie Morris Appointed to Almac’s Clinical Technologies Executive Team
Mr. Morris joins Almac as Vice President of new products and services.
Thursday, December 13, 2012
Almac Concludes Commercial API Manufacturing Facility Expansion Plans
Almac’s expansion is near completion and will be operational by the end of the year.
Tuesday, October 09, 2012
Almac Expands UK Commercial Capacity
Acquisition of new Noack N 623 blister packaging line from Romaco.
Friday, October 05, 2012
Almac Installs Uhlmann Blister Line in New US Commercial Packaging Facility
Acquisition of a high-speed blister line in Audubon, PA.
Monday, July 02, 2012
Almac Introduces QP Facilitation Programme for Conducting Trials in the European Union
Programme vastly simplifies and expedites the QP release process.
Thursday, June 14, 2012
Almac Adds High-Speed Clinical Trial Blistering Equipment at US HQ
Almac acquires PharmaWorks TF3 machine to fulfil customer's needs by increasing blistering capacity.
Tuesday, May 15, 2012
Almac Strengthens Board with Appointment of New Financial Director
Kevin Stephens’ promotion to FD is set to further enhance the Group’s financial performance and programme for international growth.
Tuesday, April 10, 2012
New Building will Help Almac Serve Customers from Argentina to Zimbabwe
New £3m building opens at Craigavon, UK headquarters.
Tuesday, April 10, 2012
Almac Expands in US with Addition of Commercial Packaging Facility in Audubon, PA.
Expansion with $10m investment in a new 100,000ft2 commercial facility in Audubon.
Monday, March 12, 2012
Scientific News
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Computerized Flexible Needles Prove Themselves in Biological Tissue
The advantage of the system is that you can avoid obstacles with the needles or critical tissues and that the system during the insertion of the needle in real time can adjust the path if, for example, the tissue deforms.
DARWIN 2 24-week Monotherapy Data in RA Confirm Previous Results
Safety profile in DARWIN 2 consistent with previous filgotinib RA studies.
Researchers Publish Landmark “Basket Study”
Researchers from Memorial Sloan Kettering Cancer Center (MSK) have announced results from the first published basket study, a new form of clinical trial design that explores responses to drugs based on the specific mutations in patients’ tumors rather than where their cancer originated.
Agricultural Intervention Improves HIV Outcomes
A multifaceted farming intervention can reduce food insecurity while improving HIV outcomes in patients in Kenya, according to a randomized, controlled trial led by researchers at UC San Francisco.
Overdose of Vitamin D in Teenagers May Lead to Increased Cholesterol Levels
Dosing obese teens with vitamin D shows no benefits for their heart health or diabetes risk, and could have the unintended consequences of increasing cholesterol and fat-storing triglycerides. These are the latest findings in a series of Mayo Clinic studies in childhood obesity.
Phase 2 Trials Underway for New Single Dose Malaria Treatment
The new drug, which prevents the malaria parasite from reproducing and spreading, is now undergoing Phase II clinical trials in humans.
Promising Drug for Parkinson's Disease
A drug which has already been in use for decades to treat liver disease could be an effective treatment to slow down progression of Parkinson’s disease, scientists from the University of Sheffield have discovered.
Benefits of Early Antiretroviral Therapy in HIV Infection
Scientists have explored the clinical importance of starting treatment early in individuals suffering with HIV.
Scroll Up
Scroll Down
SELECTBIO

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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!