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

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 3,500+ scientific posters on ePosters
  • More than 5,200+ 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 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
Nanoparticles Offer Promising Platform for Flavivirus Treatment
New nanoparticle effectively vaccinated mice against one dengue strain and could be created to target all four.
Overlooked Molecules Could Revolutionise our Understanding of the Immune System
Researchers have discovered that around one third of all the epitopes displayed for scanning by the immune system are a type known as ‘spliced’ epitopes.
Signaling Pathway Could Be Key to Improved Osteoporosis Treatment
Inhibition of SIK2 enzyme both stimulates bone formation and reduces bone breakdown in animal model.
Less Frequent Cervical Cancer Screening
HPV-vaccinated women may only need one screening every 5 to 10 years with screening starting later in life.
The Power Of Orthogonality In Assessing The Stability Of Biopharmaceuticals
By utilizing orthogonal techniques, researchers can maximize the secure application of all analytical results generated.
Dysfunction in Neuronal Transport Mechanism Linked to Alzheimer’s
Findings confirm mutation-caused problem but also reveal a new therapeutic target.
New Antibody Therapy Permanently Blocks SIV Infection
An international research team has developed an effective treatment strategy against the HIV-like Simian Immunodeficiency Virus (SIV) in rhesus macaques.
3D-Printing in Science: Conference Co-Staged with LABVOLUTION
LABVOLUTION 2017 will have an added highlight of a simultaneous conference, "3D-Printing in Science".
DNA Vaccines Protect Monkeys Against Zika Virus
Two experimental Zika virus DNA vaccines developed by NIH scientists protected monkeys against Zika infection.
Rare Flu-Thwarting Mutation Discovered
Study finds protein mutation, that is encoded by influenza, causes the virus to lose any defence against the immune system.
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,200+ scientific videos