Company results pass FDA review; no form 483 issued
RICHMOND, Va.--(BUSINESS WIRE)-- AIBioTech, LLC, Richmond, VA, is pleased to announce the successful completion of an assay validation and sample analysis program which was a critical component of EUSA Pharma’s Biologics License Application with the United States Food and Drug Administration, Center for Drug Evaluation and Research, for its Erwinaze™ (asparaginase Erwinia chrysanthemi) drug product. Erwinaze is indicated for use in combination with other anti-neoplastic agents to treat acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase.
Working under an extremely tight timeline, AIBioTech first validated the appropriate assay for use with human samples, and then used the assay to analyze clinical test samples provided by EUSA. AIBioTech underwent an on-site review of the data by the FDA, which resulted in full acceptance of the process and the results. The FDA did not issue any adverse findings as a result of their review, and EUSA Pharma was able to incorporate the results into its BLA, which was approved on November 18.
AIBioTech provides integrated research and development sciences and clinical testing services to physicians and life sciences investigators in biotechnology and pharmaceutical companies, academic institutions, and government agencies.
“AIBioTech takes great pride in the expertise of its scientific staff and its ability to deliver our services on time and on budget,” explained Dr. Robert B. Harris, President and CSO of AIBioTech. “Our Study Director, Dr. Russ Wolz, and his staff, and our Quality Assurance group made an extraordinary effort in providing the results needed by EUSA. Their work was of the highest quality as reflected by its complete acceptance by the FDA with no adverse findings. This again demonstrates how AIBioTech can successfully compete with the foremost CROs in the country.”
About AIBioTech LLC
AIBioTech is a comprehensive Contract Research Organization which provides research services, drug development, assay development, and clinical testing services to organizations involved in life sciences research and in bringing new products to market. Core laboratory services include molecular biology, microbiology, virology, immunochemistry, peptide, bioorganic, protein and bioanalytical chemistries.
AIBioTech provides consultation on experimental design and offers services under GLP and non-GLP compliance. These services are offered individually or can be integrated to support product development from discovery to market with full Regulatory Support under FDA GLP Guidelines 21 CFR part 58. Visit AIBioTech on the web at www.aibiotech.com.
Dr. Robert B. Harris, President/CSO
KEYWORDS: United States North America Virginia
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical Research FDA Science