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
Samos Energy Acquisition Corporation Announces Pricing of Initial Public Offering10.7.2026 16:32:00 EEST | Press release
Samos Energy Acquisition Corporation (the “Company”) announced today the pricing of its initial public offering (“IPO”) of 20,000,000 units at a price of $10.00 per unit. The units will be listed on the New York Stock Exchange (the “NYSE”) and trade under the ticker symbol “SAMO.U” beginning on July 10, 2026. Each unit consists of one Class A ordinary share and one-half of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one of the Company’s Class A ordinary shares at an exercise price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the NYSE under the symbols “SAMO” and “SAMO.WS,” respectively. Cantor Fitzgerald & Co. is acting as the sole book running manager for the proposed offering. The Company has granted the underwriter a 45-day option to purchase up to an additional 3,000,000 units at the IPO price. The public offering is being made
Onera hPSG ® Wins Prestigious Red Dot Product Design Award10.7.2026 16:00:00 EEST | Press release
Onera Health, a leader in transforming sleep medicine, announces that its innovative product, Onera hPSG®, has been honoured with the prestigious Red Dot Product Design Award for 2026. This international recognition celebrates exceptional design quality and underscores Onera Health's commitment to excellence, creativity, and patient-centric innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260710266668/en/ Onera Health's patch-based home polysomnography solution, Onera hPSG®, wins Prestigious Red Dot Product Design Award 2026. The Red Dot Award, one of the most sought-after seals of quality for good design, attracted thousands of entries from around the globe. Onera hPSG® stood out for outstanding functionality, striking aesthetics, and thoughtful user experience. The expert jury praised the product for translating complex sleep diagnostics into a wearable, easy-to-use system that enables low-threshold application.
teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening10.7.2026 10:00:00 EEST | Press release
teamLab Biovortex Kyoto has welcomed over 1 million visitors as of July 6, 2026, 9 months after its grand opening. (*1) These visitors arrived from more than 150 countries and regions. International visitors account for approximately 42% of the total. Many of these international visitors travel from distant countries and regions, including the United States, Australia, Canada, the United Kingdom, and Germany. Approximately 30% of these international visitors purchase their tickets at least 30 days in advance. teamLab Biovortex Kyoto is teamLab's largest museum in Japan, with an average visitor stay of over two and a half hours. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709913938/en/ teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening *1 According to ticket purchase data from the official teamLab Biovortex Kyoto website (survey period: October 7, 2025 – July 6, 2026) Visitors Comment (M
Robbyant Launches LingBot-VA 2.0 Built Natively for Embodied AI and Physical World Control10.7.2026 09:48:00 EEST | Press release
Robbyant, an embodied AI company within Ant Group, today announced the release of LingBot-VA 2.0, the industry’s first embodied-native video-action world model. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709654440/en/ A robot powered by LingBot-VA 2.0 engages in a real-time tabletop air hockey match with a human This release marks a key transition in robotics foundation models, shifting from repurposing digital world models to designing them natively for the physical world. Instead of relying on fine-tuned digital content generation models, LingBot-VA 2.0 is built from scratch to meet the original demands of dynamic modeling, causal prediction, and real-time execution in physical environments. Integrating world models with embodied AI has been one of the major focuses of the AI industry. However, most mainstream approaches rely on video generation models designed for digital content, which are then fine-tuned for robo
SureWerx Appoints Erik Pertot as VP/GM SureWerx EMEA10.7.2026 09:00:00 EEST | Press release
SureWerx, a leading global manufacturer of personal protective equipment, safety products, tools and equipment solutions, today announced the appointment of Erik Pertot as VP/GM SureWerx EMEA. Pertot will report directly to CEO Scott Dowell and will lead growth, manufacturing and M&A activities in Europe across the company’s global portfolio. Erik joins SureWerx with more than 20 years of international leadership experience across engineering, quality, marketing, sales, international supply chain, product management, and general management. He brings deep expertise in the personal protective equipment industry, with a track record of leading complex, compliance-critical programs, managing business transitions, and driving growth across multinational environments. Most recently, Pertot served as Global General Manager for Footwear and Fall Protection at Protective Industrial Products (PIP), where he also held senior portfolio management leadership roles. Prior to that, he held a series
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