Business Wire

C-LECTA

Share
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.

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Belkin Achieves Qi2.2 Certification for Its Upcoming Products, Unlocking the Future of 25W Wireless Charging15.7.2025 19:06:00 CEST | Press release

With Qi2.2 certification, Belkin reinforces its commitment to quality, safety, and performance for the next generation of wireless charging Belkin, a leading consumer electronics brand for over 40 years, today announced it has received official Qi2.2 certification from the Wireless Power Consortium (WPC) for its upcoming products. As one of the first accessory brands to deliver Qi2.2-certified devices, Belkin is helping bring the next generation of wireless charging to market – enabling faster wireless charging speeds, broader compatibility, and improved performance for consumers. Belkin’s close partnership with the WPC since 2015 has been instrumental in bringing these advancements to consumers. As an early adopter and long-time contributor to WPC standards, Belkin was selected as one of a small group of trusted manufacturers to test and certify Qi2.2 products ahead of the broader industry rollout. All Belkin products undergo rigorous safety, quality, and performance testing. The comp

Cessna Grand Caravan EX to Feature New Executive Interior Options, Expanding Opportunities for Elevated Missions15.7.2025 18:05:00 CEST | Press release

The legendary Cessna Grand Caravan EX will now feature three new executive interior schemes for customers to select when designing their aircraft cabin. The Lunar, Obsidian and Saddle Sport interiors join the existing Canyon and Savanna schemes, providing a broader range of standard choices. The new interior options are available to customers starting this month and allow them to further tailor the interior of their aircraft based on their personal preference or mission. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250715021096/en/ Cessna Grand Caravan EX to feature new executive interior options, expanding opportunities for elevated missions (Photo Credit: Textron Aviation) The Cessna Grand Caravan EX is designed and manufactured by Textron Aviation Inc., a Textron Inc. (NYSE:TXT) company. Premium versions of each of the new interiors are also available, featuring quilted seat stitching and plush carpet, providing an elev

7 Million Tokens Sells Out in less than One Hour—$MBG Token Pre-Sale Shatters Expectations15.7.2025 17:27:00 CEST | Press release

MultiBank Group, the world’s largest and most regulated financial derivatives institution, has set a new benchmark in digital asset launches. The Group’s $MBG Token Pre-Sale sold out in less than one hour with all 7 million tokens fully subscribed across MultiBank.io and Uniswap. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250715055611/en/ The Group’s $MBG Token Pre-Sale sold out in less than one hour with all 7 million tokens fully subscribed across MultiBank.io and Uniswap. Commenting on the success of the Pre-Sale, Naser Taher, Founder and Chairman of MultiBank Group, said: “The sell-out of our initial $MBG Token offering in less than one hour is a decisive validation of our vision. In a market saturated with speculation, the response we received confirms that institutional-grade transparency, regulatory integrity, and asset-backed value are what investors are now demanding. $MBG is here for the long term, reflecting t

First Patient Enrolled in National Cancer Institute’s Vanguard Study Evaluating Guardant Health’s Shield Multi-Cancer Detection Test15.7.2025 17:01:00 CEST | Press release

Study addressing feasibility of using multi-cancer detection tests in future trials aims to enroll up to 24,000 participantsShield MCD reviewed by FDA as part of NCI’s investigational device exemption (IDE) Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that patient enrollment has begun in the National Cancer Institute (NCI)’s Vanguard Study to evaluate emerging multi-cancer detection (MCD) technology. Guardant’s Shield™ MCD test was selected for use in the four-year study, which aims to enroll up to 24,000 patients and evaluate the use of MCD tests—blood tests that can screen for several types of cancer simultaneously—in future randomized controlled trials. Guardant’s Shield MCD test was chosen for the study based on the overall performance of its Shield platform in detecting 10 cancer types, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver and gastric. The data were presented at the 2025 American

Deltatre Announces Acquisition of Endeavor Streaming to Create Digital and Streaming Platform Leader15.7.2025 16:15:00 CEST | Press release

Deltatre, a leading international provider of streaming, digital, data, and graphics solutions for the sports, media, and entertainment industries, today announced it has entered into a definitive agreement to acquire Endeavor Streaming from Endeavor Group Holdings, Inc. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250715833650/en/ Deltatre announces acquisition of Endeavor Streaming. In bringing together these complementary and proven digital and OTT providers, Deltatre is joining its advanced product suite – D3 VOLT, FORGE, AXIS, and DIVA, which delivers multi-functional digital experiences with integrated video – with Endeavor Streaming’s pure-play OTT product, VESPER. They will also unite their digital strategy, consulting, and direct-to-consumer growth marketing services. The combined business will be best equipped to deliver for sports, media, and entertainment clients through a compelling and comprehensive range of

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye