c-LEcta: Drug Master File for the Use of the Enzyme DENARASE® in the Pharmaceutical Industry Accepted by the US FDA
31.8.2021 10:00:00 EEST | Business Wire | Press release
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
Azizi Developments Introduces USD 8.1 Billion Master-Planned Community Azizi Florence in Sharjah10.9.2026 17:08:00 EEST | Press release
Azizi Developments, a leading private developer in the UAE, is unveiling Azizi Florence, a USD 8.1 billion master-planned community marking its first project in Sharjah. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910091949/en/ Azizi Florence (Photo: AETOSWire) The freehold development will feature 1,130 villas, more than 6,000 townhouses and 3,500 apartments, with three-bedroom townhouses starting from USD 515,000 at USD 231 per square foot of sellable area. Designed as an integrated destination, Azizi Florence will bring together residential, retail, hospitality, education, leisure and wellness offerings, centred around a 1.7-million-square-foot Central Park. Six residential clusters will each feature a park, clubhouse, community centre and landscaped gardens. Mr. Mirwais Azizi, Founder and Chairman of Azizi Group, said: “Returning to Sharjah after more than three decades is deeply meaningful to me, as this emirate w
Agentic Crypto Payments Have Surged by 500% 1 in the Last Three Months, Crypto Compliance Must Become Agentic Too10.9.2026 16:53:00 EEST | Press release
Elliptic,the global leader in on-chain risk, today published the Elliptic Standard: eight principles for governing agentic on-chain risk. Elliptic has been at the intersection of financial crime and on-chain finance since 2013, long enough to recognize the shift to agentic transactions as a defining inflection point in financial crime risk, and to be the first to define what governing it demands. On-chain finance is now running at agentic speed. Machines are originating, authorizing and settling transactions at a volume no human team can review. Illicit actors are using AI to evade detection at a speed and volume that manual processes cannot track. Models built around human review were never designed for this world. They are already overwhelmed. Three forces are driving this shift. First, autonomous agents are increasingly the counterparty on both sides of a transaction, not just people initiating activity for software to review: research from PHD and WARC2 projects agent-facilitated c
Wasabi Establishes AI Business in Silicon Valley, Taps Pinaki Mukherjee to Lead as Senior Vice President & General Manager10.9.2026 16:00:00 EEST | Press release
Wasabi Technologies, the hot cloud storage company, today announced the formation of a dedicated AI business, and the appointment of semiconductor and storage veteran Pinaki Mukherjee as senior vice president and general manager to lead it. Wasabi stores hundreds of petabytes of AI data for frontier model labs, generative AI startups, and neocloud compute providers worldwide. This new AI business brings dedicated strategy, partnerships and go-to-market focus for this demand as AI infrastructure matures. “Mukherjee has a track record of driving the kind of high-value partnerships that move markets, and that’s exactly what this moment requires,” said Marty Falaro, president and COO of Wasabi. “AI workloads are pushing storage demand to a scale we've never seen, and Mukherjee is the right person to build the partnerships that extend Wasabi's position as the industry's choice for cloud storage, at the exact moment inference is reshaping what that storage needs to do.” Proven leadership in
Ant Group’s AI Health App AQ Reaches 150 Million Users as It Expands AI-powered Day-to-day Health Use Cases10.9.2026 15:47:00 EEST | Press release
At the 2026 INCLUSION · Conference on the Bund in Shanghai, Zhang Junjie, Vice President of Ant Group and Head of the Health Business, announced that Ant Group’s flagship AI health app AQ has reached 150 million users, handling nearly 20 million health inquiries per day. The new milestone also means AQ has grown its user base by 50% in just 8 months, since it announced 100 million users in February 2026, reflecting strong demand in China’s AI health space. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910921103/en/ Ant Group’s AI health app AQ provides personalized health advice based on more than 10 health indicators. Health has become an increasingly important priority among Chinese consumers. According to Accenture’s China Consumer Insights report published in November 2025, the share of Chinese consumers who considered health a priority increased from 78% in 2021 to 87% in 2025, making it the top priority among the a
AULUMU Introduces A18 Series for iPhone 18 With Aramid Fibre, Hybrid Protection and Distinctive Finishes10.9.2026 15:43:00 EEST | Press release
Technology accessories brand aulumu has introduced the A18 Series for iPhone 18, a new collection of smartphone cases designed around lightweight protection, material innovation and distinctive visual finishes. The range includes the A18 Armor Shockproof Aramid Fiber Case, two ultra-slim aramid fibre models, the Ghost Lumen Transparent Case, and the Particle Vegan Leather Case. At the centre of the collection, the A18 Armor combines 1500D aramid fibre and thermoplastic polyurethane (TPU) in a one-piece construction. The hybrid structure pairs the light weight and woven texture of aramid fibre with the flexibility and cushioning properties of TPU. A full-wrap design covers the phone’s edges, while reinforced corners are intended to help distribute impact from everyday drops and bumps. The case is designed to provide drop protection from heights of up to 2 metres, with a 1.36 mm raised screen edge and a 1.3 mm raised camera frame providing additional protection around key areas. The A18
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