Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

PPD Expands cGMP Cell-based Assay Laboratory

Published: Thursday, March 28, 2013
Last Updated: Thursday, March 28, 2013
Bookmark and Share
Larger facility offers additional testing capabilities to meet client needs.

Pharmaceutical Product Development, LLC (PPD) is expanding its cGMP cell-based assay laboratory in Middleton, Wis., to meet the growing needs of clients seeking to validate bioassays for product release and stability testing of biological products, both as novel drugs and as biosimilars. The Middleton cell lab will now support a significantly greater volume of bioassay development, validation and testing projects and provide a broader range of product testing capabilities.

“Biotech and pharmaceutical companies are shifting their strategies to developing high-value, niche therapies utilizing biologics, a trend that is expected to generate significant growth in characterization of biologics, as well as biosimilars,” said Magdalena Mejillano, Ph.D., vice president of cGMP labs for PPD. “Expanding our capabilities to perform additional cell-based assays that establish the potency and stability of these biologics gives clients greater capacity, flexibility and efficiency in testing their products.”

PPD’s cell-based lab initially was created to address and respond to requirements for development, validation and testing under established U.S. Pharmacopeial Convention, International Conference on Harmonisation and U.S. Food and Drug Administration cGMP guidelines. The cell lab facility has been expanded to approximately 6,800 square feet, which will allow for a much broader range and increased volume of testing capabilities. The expansion will add the following capabilities: ability to handle ISO-certified clean-room growth and qualification of cell lines; quarantined segregation of early development projects; increased bioassay capacity and segregation of projects; and BL2/3 isolation for working with viral-based products.


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 3,300+ scientific posters on ePosters
  • More than 4,900+ 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

PPD Awarded U.S. Army and BARDA Research Contracts
Providing clinical development and vaccine services.
Friday, October 16, 2015
Scientific News
Breakthrough Flu Vaccine Inhibited by Pre-existing Antibodies
Universal truths – how existing antibodies are sabotaging the most promising new human flu vaccines.
Zika Vaccine Candidates Show Promise
Two experimental vaccines have shown promise against a major viral strain responsible for the Brazilian Zika outbreak.
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Antibody Drug Shows Promise in HIV Treatment
Researchers are a step closer to an alternative HIV treatment that has the potential for lasting effects and less frequent dosing.
Flu Vaccine May Reduce Risk of Death For Type 2 Diabetes Patients
Researchers at Imperial College London have suggested that the vaccine may have substantial benefits for patients with long-term conditions.
Flu Vaccine May Reduce Death Risk of Type 2 Diabetes
New research suggests that a new flu vaccine may reduce probability of type 2 diabetes patients being hospitalised with stroke and heart failure.
Disrupting Tumour-Promotion in Humans
Researchers have modified an existing protein to represses a specific cancer-promoting ‘message’ within cells.
Protein Nanocages Could Improve Drug Design and Delivery
HHMI scientists have designed and built 10 large protein icosahedra that are similar to viral capsids that carry viral DNA.
Vaccine Strategy Targets Multiple Influenza Viruses
Scientists have identified vaccine-induced antibodies that can neutralize strains of influenza virus that infect humans.
Antibody-Based Drug for Multiple Sclerosis
New antibody-based drug paves the way for new strategies for controlling and treating multiple sclerosis.
Skyscraper Banner

SELECTBIO Market Reports
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!