c-LEcta: Drug Master File for the Use of the Enzyme DENARASE® in the Pharmaceutical Industry Accepted by the US FDA
c-LEcta, a global biotechnology company with technology leadership in enzyme engineering and bioprocess development, has announced the submission of a Master File for its best-selling product DENARASE ® . The filing with the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) is intended to assist DENARASE ® customers with regulatory approvals of biopharmaceuticals, such as vaccines and advanced therapy medicinal products. The Master File demonstrates the suitable 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 therapeutic agents as well as vaccines. The Master File (Type II) contains detailed information on the production, processing, packaging and storage of DENARASE ® .
This comprehensive documentation demonstrates to the regulatory authority that the product is of suitable quality for use in pharmaceutical products. The submission, available in eCTD format, can be used to support regulatory filings such as Biologic License Applications (BLA), Investigational New Drugs (IND), New Drug Applications (NDA), and others. “This means the DENARASE® Master File helps to meet regulatory requirements for biopharmaceuticals, vaccines and other drugs to demonstrate their quality, safety and efficacy,” said Dr. Paula Pescador, VP of Regulatory Affairs at c-LEcta.
The FDA has accepted the submission and assigned Master File number 27708 as a reference. c-LEcta is now ready to provide its customers with a signed and designated Authorization Letter (LoA) for their product registrations with the US FDA upon request.
“By submitting this Master File, we strengthen our customers’ confidence in the quality of our product while helping to reduce the regulatory burden in their development and approval process,” commented Dr. Marc Struhalla, Founder and CEO of c-LEcta.
About c-LEcta
c-LEcta is a world-leading biotechnology company with a focus on enzyme engineering and application in regulated markets like the food and pharma industries. The company is based in Leipzig, Germany, and has established itself as a leading player in the realization of high-value biotech products, either in the form of in-house developments or in close cooperation with industry. The company currently employs more than 100 people.
c-LEcta delivers cost-efficient and sustainable production processes which open new markets and allow for better penetration of existing markets. The company is characterized by fast and efficient development of best-in-class biotech solutions and a rapid and successful market introduction and commercialization of the resulting products. This enables c-LEcta to leverage the unique potential of its core technologies. c-LEcta has a proven track record of more than ten successfully commercialized high-value industrial biotech products.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210831005367/en/
Contact information
cometis AG
Matthias Kunz
Phone: +49 (0) 611 - 205855 – 64
Fax: +49 (0) 611 - 205855 – 66
Email: kunz@cometis.de
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
European Commission (EC) Approves Henlius and Organon’s BILDYOS ® (denosumab) and BILPREVDA ® (denosumab), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively19.9.2025 13:00:00 EEST | Press release
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for BILDYOS® (denosumab) injection 60 mg/mL and BILPREVDA® (denosumab) injection 120 mg/1.7 mL,biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250919502394/en/ “The EC approvals of BILDYOS and BILPREVDA mark a pivotal moment in expanding access to essential bone care treatments for millions of Europeans, particularly women, who are disproportionately affected by osteoporosis,” said Nico Van Hoecke, Head, International Commercial at Organon.3,4 “These biosimilars may offer additional treatment options across several therapeutic areas associated with bone loss, including osteoporosis, and reflect Organon’s commitment to advancing women’s health through access to im
Cluster Reply Supports Riverty’s AI-first Strategy for Omnichannel, Human-centric Customer Service19.9.2025 12:15:00 EEST | Press release
Cluster Reply, the Reply company specialised in digital platform solutions leveraging Microsoft technologies, has partnered with fintech company Riverty to accelerate the rollout of a pioneering customer service platform – delivered in record time of just 100 days. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250919101836/en/ The initiative is part of Riverty’s broader strategy to become a leader in AI-powered financial services. The new solution empowers Riverty to deliver efficient, empathetic customer support across all channels while creating a robust foundation for future AI-driven automation. The initiative is part of Riverty’s broader strategy to become a leader in AI-powered financial services. The new solution empowers Riverty to deliver efficient, empathetic customer support across all channels while creating a robust foundation for future AI-driven automation. The platform leverages Microsoft Dynamics 365 Custom
L&T Technology Services Joins the MIT Media Lab to Collaborate on AI-led Innovations19.9.2025 11:30:00 EEST | Press release
L&T Technology Services (BSE: 540115, NSE: LTTS), a global leader in AI, Digital & ER&D Consulting Services, today announced a multi-year membership agreement with the MIT Media Lab, one of the world’s most prestigious research institutions. As a consortium Lab Member, LTTS intends to explore next-generation advancements in artificial intelligence (AI), underscoring its commitment to driving transformational innovation in Mobility, Sustainability and Tech. As part of the agreement, LTTS will engage in active discussions and information exchange with the Media Lab’s unique cross-disciplinary ecosystem that brings together researchers, innovators and industry leaders. The collaboration not only emphasizes practical AI innovation but also accelerates technology-driven advancements by linking LTTS’ expertise in AI and engineering with the Media Lab’s unique research approach. Together, they intend to explore sustainable engineering solutions that redefine industries, from creating smarter
REJO MULTI Unveiled at InterTabac 2025, Featuring Dual-Heating and Cross-Brand Compatibility19.9.2025 11:00:00 EEST | Press release
REJO, a global heat-not-burn (HNB) pioneer, officially unveiled REJO MULTI device at InterTabac 2025 as one of the exhibition’s most anticipated products. The device introduces a dual-heating system that pairs AirFlow and Round Heating technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250919713971/en/ REJO MULTI Product Launch Event “REJO MULTI represents a major step forward in HNB technology,” said Loic Li, the Global Sales Director of REJO. “Its open compatibility allows users to explore multiple brands and flavors with a single device, while our dual-heating system ensures even heating, enhanced aroma delivery, and consistent nicotine satisfaction.” “Our goal with REJO MULTI is to empower users with choice and flexibility, while providing retailers and partners with an innovative, market-ready product that elevates the smoking alternative experience,” said Tibor Braun, the Western Europe Manager of REJO. “This
SMBC Group and Jefferies Significantly Expand Their Global Strategic Alliance19.9.2025 11:00:00 EEST | Press release
Jefferies Financial Group, Inc. (NYSE: JEF) (“Jefferies”) and Sumitomo Mitsui Financial Group, Inc. (NYSE: SMFG) (“SMFG”), Sumitomo Mitsui Banking Corporation (“SMBC”), and SMBC Nikko Securities Inc. (“SMBC Nikko”) (collectively, “SMBC Group”) announced today that they are significantly expanding their Global Strategic Alliance. SMBC Group and Jefferies initially entered into a Strategic Alliance in 2021 to collaborate on future corporate and investment banking business opportunities. In 2023, the Alliance was expanded to enhance collaboration across M&A, equity and debt capital markets, with a particular focus on investment grade clients in the U.S. SMBC Group and Jefferies subsequently added Memoranda of Understanding to expand their alliance to the EMEA region, Canada, Asia and Australia, as well as to expand the scope of Joint Coverage initiatives to larger global sponsors, pre-IPO companies, and sub-investment grade corporate clients. Today, Jefferies and SMBC Group announce the n
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom