c-LEcta, a global biotechnology company with technology leadership in enzyme engineering and bioprocess development, announces the submission of a master file for its best-selling product DENARASE®. The submission to the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research is intended to assist DENARASE customers with regulatory approval of biopharmaceuticals, such as vaccines and advanced therapy drugs. The master file proves the quality of DENARASE for use in pharmaceutical products.
DENARASE, a so-called endonuclease, is an enzyme used in the biopharmaceutical industry to remove DNA in the purification of vaccines and vaccines. The Master File (Type II) contains detailed information about the manufacture, processing, packaging and storage of DENARASE®.
This comprehensive documentation proves to the regulatory authority that the product is of suitable quality for use in pharmaceutical products. The submission, which is available in eCTD format, can be used to support regulatory submissions such as Biologic License Applications (BLA), Investigational New Drugs (IND), New Drug Applications (NDA), and others. dr Paula Pescador, VP Regulatory Affairs at c-LEcta: “This supports DENARASE® Master File the regulatory requirements for biopharmaceuticals, vaccines, and other drugs to demonstrate their quality, safety, and efficacy.”
The FDA has accepted the submission and assigned master file number 27708 to c-LEcta for reference. c-LEcta is now ready to provide its customers with a signed and named Authorization Letter (LoA) for their product registrations with the US FDA upon request.
dr Marc Struhalla, Founder and CEO of c-LEcta, comments: "By submitting this master file, we are strengthening our customers' trust in the quality of our product and at the same time helping to reduce the regulatory effort in their development and approval process."
c-LEcta is a global biotechnology company with technology leadership in the areas of enzyme engineering and bioprocess development for regulated markets such as the food and pharmaceutical industries. The company, based in Leipzig, has established itself as a leading supplier of high-quality biotechnological products, be it in-house developments or in close cooperation with industry. c-LEcta currently employs more than 100 people.
c-LEcta delivers cost-efficient and sustainable production processes that open up new markets and enable better penetration of existing markets. The company excels at rapidly and efficiently developing best-in-class biotech solutions and successfully bringing to market and commercializing the resulting products. This allows c-LEcta to develop the unique potential of its core technologies. c-LEcta already has more than ten successfully marketed, high-quality, industrial biotech products.
Source: Press release c-LEcta from November 31.08.2021th, XNUMX