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
monday.com Appoints Ben Barnett General Manager of EMEA to Drive Next Phase of Regional Growth9.6.2026 11:00:00 EEST | Press release
monday.com (Nasdaq: MNDY), the AI work platform that turns strategy into execution at scale, today announced Ben Barnett’s appointment to General Manager (GM) of Europe, the Middle East and Africa, marking a major milestone in the company’s global expansion. Ben, who has been with monday.com for five years, brings a decade of experience in senior B2B sales roles at software companies and has overseen significant, sustained growth at monday.com in the UK and Ireland since joining in 2021. In his new position, Ben’s priorities include delivering the monday.com’s EMEA go-to-market strategy, fostering key partnerships, and bolstering its newly announced AI work platform. He is based in London. Ben’s promotion comes as monday.com builds on a period of rapid regional success, with EMEA revenue up 26% year-on-year in 2025. Last year, monday.com expanded its regional EMEA headquarters in Fitzrovia, London, now occupying 80,000 sq ft across three floors where more than 370 employees are based,
Interactive Brokers Launches Commission-Free iShares ETFs from BlackRock through Recurring Investment Feature Across Europe9.6.2026 11:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the launch of Commission-Free ETFs within its Recurring Investment feature for eligible individual investors across the European Economic Area. Investors can now access more than 500 commission-free iShares ETFs from BlackRock spanning a broad range of asset classes and strategies, including bonds, equities, themes and sectors. The iShares ETFs available on the IBKR platform give individual investors an accessible, cost-efficient way to build well-diversified portfolios. Since investors pay no trading commissions, more of their capital stays invested and compounding over time, while a broad selection of funds across asset classes makes it straightforward to construct and rebalance portfolios. iShares ETFs are available commission-free through IBKR's Recurring Investments feature, allowing investors to automate their periodic ETF contributions. Clients can select individual ETFs or ETF portfolios, set a cont
Forrester Reveals The Top 10 Highest-Performing Brands In Its 2026 Global Total Experience Score Rankings At Its CX Events9.6.2026 10:30:00 EEST | Press release
According to Forrester’s (Nasdaq: FORR) 2026 global Total Experience Score rankings of 375 brands evaluated across Asia Pacific, Europe, and North America in 2025 and 2026, 41% improved their scores while only 3% declined. A compelling total experience — calculated by combining Forrester’s Customer Experience Index (CX Index™), Brand Experience Index (BX Index™), and, for the first time, the new Employee Experience Index (EX Index™) into a unified view of performance — can drive outsized growth for brands. While brand experience and customer experience can each drive revenue independently, the impact multiplies when they are orchestrated together as a unified total experience. In the US, for example, companies delivering a strong total experience see significantly higher returns from retention and enrichment: Automotive firms achieve a 2.6x revenue lift and retailers see a 3.8x increase. The new research finds that CX scores improved in North America, European brands remained mostly st
IQM Announces Novel Quantum Error Correction Approach Toward Fault-Tolerant Quantum Computing9.6.2026 10:00:00 EEST | Press release
IQM Quantum Computers, the global leader in superconducting quantum computers, has developed a novel quantum error-correcting code that achieves up to three orders of magnitude lower logical error rates than the surface code, also requiring up to eight times fewer physical qubits. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260609533201/en/ IQM´s breakthrough technology, called barbell codes. Unlike many alternative high-performance quantum error-correction approaches, the new code also maintains a comparatively low hardware complexity, marking a significant advancement toward scalable fault-tolerant quantum computing. Quantum error correction remains one of the defining challenges in the race toward practical quantum computing. Errors introduced by noise must be corrected faster than they accumulate, a requirement that previous approaches demanded either complex hardware or significant performance trade-offs, which IQM's
Longpoint Expands into Germany and the Netherlands, Targeting €400 Million of Infill Logistics Investment9.6.2026 10:00:00 EEST | Press release
Longpoint Partners today announced its expansion into Germany and the Netherlands, extending its infill industrial strategy into two of Europe’s most supply-constrained logistics markets. The firm is establishing a presence in high-demand locations, including Düsseldorf, Frankfurt, and the Randstad, and plans to deploy approximately €400 million into logistics assets near major population centers and transportation corridors. “We are excited to expand Longpoint’s infill industrial strategy into Germany and the Netherlands,” said Dwight Angelini, Founding and Managing Partner of Longpoint Partners. “These are highly attractive logistics markets with strong fundamentals, limited supply, and a clear need for high-quality light industrial and logistics space. With Gijs and Benedict leading our local efforts, we have the market knowledge, relationships, and discipline to identify attractive opportunities and execute with conviction.” The expansion extends Longpoint’s focus on infill logisti
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