Bioassay GmbH, a Reaction Biology Company, Obtains GMP Manufacturing License for Quality Control Testing on Veterinary Products
Heidelberg, Germany September 10, 2024 – Bioassay GmbH, a leading provider of bioanalytical testing solutions, is pleased to announce that it has successfully obtained a veterinary Good Manufacturing Practice (GMP) license according to Art. 88 of Regulation (EU) 2019/6. This significant milestone enables the company to perform quality control testing on veterinary products, ensuring they meet the highest regulatory standards of safety and efficacy.
The veterinary GMP license demonstrates Bioassay’s continued commitment to excellence in quality control and quality assurance, and further extends Bioassay’s already existing GMP certification. With this new license, the company will now offer potency testing services for veterinary pharmaceutical products, in compliance with strict regulatory guidelines for GMP organizations and laboratories.
“The extension of our GMP license marks a pivotal expansion for Bioassay GmbH,” said Sven-Michael Cords, COO of Bioassay GmbH. “This license reflects our ongoing dedication to maintaining the highest standards in quality control and now enables us to better support the veterinary pharmaceutical industry. Ensuring the safety and effectiveness of veterinary products is critical, and we are proud to contribute to the well-being of animals through our enhanced testing capabilities.”
Within its expanded GMP-certified quality control testing capabilities, Bioassay GmbH is equipped to provide both in vivo and in vitro bioanalytical testing, including:
- Development and validation of biological assays, both in vitro and in vivo
- In vitro and in vivo GMP routine Potency testing for human and veterinary products
- In vivo and in vitro GLP testing
- In vitro functional bioassays
- In vivo, in vitro and ex vivo immunotoxicity evaluation
These services are designed to help animal health companies meet regulatory requirements and ensure that their products are safe and effective for use in animals. The company’s team of experienced study directors, scientists and technicians are well versed in GMP protocols and dedicated to delivering accurate, reliable results.
“Achieving this GMP license amendment is the culmination of our team’s hard work and unwavering commitment to quality,” said Natascha Hach, Head of Quality Assurance at Bioassay GmbH, “We are excited to leverage our expertise and years of GMP experience to help the veterinary industry ensure that products for animals are safe and effective.”
For more information about Bioassay GmbH and its GMP-certified quality control testing services, please visit www.bioassay-online.com or contact us.
About Bioassay GmbH – A Reaction Biology Company:
Bioassay GmbH, a Reaction Biology Company, is a premier provider of pharmaceutical bioanalytical testing. With a focus on quality, and customer satisfaction, the company offers a comprehensive range of services to the pharmaceutical, biotechnology, veterinary, cosmetic and chemical industries. Bioassay GmbH is committed to advancing the field of pharmaceutical testing through continuous improvement and adherence to the highest industry standards and GXP regulations.
About Reaction Biology
Founded in 2001, Reaction Biology is a global contract research organization (CRO) that provides drug discovery and development services to biopharmaceutical customers worldwide. Reaction specializes in supporting research goals with capabilities that include protein and peptide production, biochemical and biophysical assays, high throughput screening, exploratory toxicology, biomarker discovery tools, and an extensive array of cell-based and pharmacological assays modelling various diseases. Reaction also provides Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) analytical and functional bioassays for testing potency, efficacy, and safety of large biological molecules, enabling clinical and commercial manufacturing batch release. Reaction has helped to advance many of its customers’ molecules through discovery and development pipeline stages into later clinical phases. These molecules may ultimately benefit patients living with cancer and other serious diseases. Reaction maintains one of the largest panels of kinase assays in the world with over 750 unique assays and performs more than 5,000 client projects annually with its over 2,000 validated assays.
Reaction has laboratory facilities in Malvern, PA, Hershey, PA, Freiburg, Germany, and Heidelberg, Germany. For more information, visit www.ReactionBiology.com and follow us on Twitter @ReactionBiology and on LinkedIn.