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Frontage Laboratories Achieves Key Milestone for its Suzhou Toxicology Facility

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Frontage Laboratories has achieved a significant milestone with its new toxicology facility in Suzhou, China, receiving an "Experimental Animal Use License" from Jiangsu's Provincial Department of Science and Technology on January 21, 2022. The facility, covering 200,000 square feet, will conduct GLP and non-GLP toxicology and drug metabolism studies. Frontage plans to initiate validation studies of drug safety by Q2 2022 and expects to offer non-GLP studies soon. This facility, alongside others in Chicago and Ohio, will enhance Frontage's capabilities in supporting drug development programs.

Positive
  • Achieved Experimental Animal Use License for the Suzhou facility, enhancing operational credibility.
  • Facility is designed to support comprehensive toxicology and drug metabolism studies, fostering growth potential.
  • Plans to launch validation studies and non-GLP services demonstrate proactive business expansion.
Negative
  • None.

EXTON, Pa., Feb. 3, 2022 /PRNewswire/ -- We are excited to announce that our new toxicology facility in Suzhou, China has achieved a key milestone when Jiangsu's Provincial Department of Science and Technology granted the site an "Experimental Animal Use License" on January 21, 2022, following an on-site inspection and review of recently completed construction.

The custom-designed 200,000 square foot, 100 animal room facility will house all major laboratory species (including Non-Human Primates) and will undertake GLP and non-GLP in vivo and in vitro toxicology, safety and drug metabolism studies to support drug and chemical registration in China and globally.  The state-of-the art design includes supporting laboratories for bioanalysis, chemistry, clinical pathology, histology, genetic toxicology and safety pharmacology, alongside segregated housing areas for each species.

With this milestone achieved, Frontage plans to launch a program of single and repeat dose validation studies in all major species by Q2 2022 as part of the process to obtain certification for the conduct of commercial GLP studies, which we anticipate receiving by late 2022.  In addition, Frontage expects to begin offering non-GLP toxicology and drug metabolism studies at the Suzhou site in the near future.

Frontage's Executive Vice President of Global Safety & Toxicology (and President for North American Operations), Glenn Washer said, "With the addition of the Suzhou, China site as our third toxicology facility – along with our recently acquired Experimur LLC toxicology business in Chicago, IL and our existing toxicology site in Concord, OH – Frontage's ability to support our clients' safety & toxicology programs will be greatly expanded.  These three facilities will address all categories of drug development toxicology from early discovery toxicology, to IND-enabling and through later NDA-enabling toxicology, including developmental and reproductive toxicology and routine and transgenic carcinogenicity bioassays."

About Frontage (www.frontagelab.com) 
Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals.  Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.  For more details visit: www.frontagelab.com 

CONTACT: Bryan Newman, bnewman@frontagelab.com

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SOURCE Frontage Laboratories, Inc.

FAQ

What milestone did Frontage Laboratories achieve on January 21, 2022?

Frontage Laboratories received an 'Experimental Animal Use License' for its new toxicology facility in Suzhou, China.

What services will Frontage's Suzhou facility provide?

The facility will conduct GLP and non-GLP toxicology, safety, and drug metabolism studies.

When does Frontage plan to initiate validation studies at the Suzhou site?

Validation studies are expected to begin by Q2 2022.

How large is the new toxicology facility in Suzhou, China?

The facility spans 200,000 square feet.

What additional facilities does Frontage operate for toxicology?

Frontage also operates facilities in Chicago, IL, and Concord, OH.

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