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
In the age of AI agents, Splio makes prediction the foundation of CRM and launches its AI-first CRM12.2.2026 10:30:00 EET | Press release
Splio announces the launch of its AI-first CRM powered by Tinyclues AI. Now integrated at the core of the platform, predictive AI helps brands orchestrate and personalize their communications at scale across every channel (email, SMS, RCS, WhatsApp...). Splio also unveils "Ask My CRM," its new AI agent designed as an intelligent marketing copilot that, plugged into each brand's customer data, makes customer knowledge easier to access, and speeds up day-to-day CRM management, from analysis to actionable recommendations. Splio made the strategic choice early on to invest in AI, especially with the acquisition of Tinyclues in 2023, to get ahead of rapid changes in the CRM Market. Today, the company runs an AI-first model with 30% of its annual recurring revenue coming from its AI offerings. Companies such as Air France, Fnac Darty, SNCF Connect, Samsung, as well as ETAM, Maisons du Monde, Mademoiselle bio, and Cyrillus in retail, already rely on Tinyclues AI on a daily basis. "We quickly
Stafford Capital Partners Announces New Renewable Energy Investment Strategy with Dedicated Team12.2.2026 10:00:00 EET | Press release
Stafford Capital Partners (“Stafford”), a leading international private markets investment and advisory firm, today announced the launch of a new strategy focused on the renewable energy sector. This initiative leverages the ongoing transformation and rapid growth within the renewables market, targeting the revamping and repowering of existing renewable assets to deliver compelling risk-adjusted returns while accelerating the transition to a low-carbon economy. This new strategic initiative further strengthens Stafford’s position in the global infrastructure investment market, providing institutions with access to a pioneering investment approach to renewable investing. This mirrors the differentiated approach Stafford has taken in developing its secondary market strategies across its real assets platform. The implementation of this strategy is driven by the integration of a dedicated 11-person team, based in Milan and Zurich, led by Angelo Prete. Stafford has worked successfully with
KARL LAGERFELD Reunites With Paris Hilton for Spring – Summer 2026 “From Paris with Love” Campaign12.2.2026 09:00:00 EET | Press release
KARL LAGERFELD unveils its Spring–Summer 2026 campaign, From Paris with Love, starring cultural icon Paris Hilton for the second consecutive season. Captured through the lens of long-time brand collaborator Chris Colls at the Maison’s headquarters, 21 Rue Saint-Guillaume in Paris, the global campaign spans the KARL LAGERFELD, KARL LAGERFELD JEANS, and KARL LAGERFELD PARIS collections. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211077844/en/ KARL LAGERFELD SS26 Campaign Paris Hilton - ©Chris Colls “Shooting the campaign at 21 Rue Saint-Guillaume was incredibly inspiring,” says Paris Hilton. “Stepping into Karl’s world felt personal and true to the DNA of both Karl and the brand. It wasn’t about looking back but being present in a space where his legacy continues to evolve.” Moving through the Maison with ease and confidence, Paris Hilton brings her signature glamour and charisma to KARL LAGERFELD’s universe through pla
AB InBev Reports Full Year and Fourth Quarter 2025 Results12.2.2026 08:01:00 EET | Press release
Anheuser-Busch InBev (Brussel:ABI) (BMV:ANB) (JSE:ANH) (NYSE:BUD): This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211688662/en/ Figure 14. Terms and debt repayment schedule as of 31 December 2025 (billion USD) Regulated and inside information1 “Beer plays an important role in bringing people together and creating moments of celebration. In 2025, we executed our strategy, made disciplined capital allocation choices and delivered growth within our outlook for the year, even as we navigated a dynamic consumer environment. We exit 2025 with improved momentum and enter 2026 well positioned to engage consumers with our megabrands and an unparalleled lineup of mega platforms. Thank you to our colleagues for their ongoing commitment, hard work and passion for our business.” – Michel Doukeris, CEO, AB InBev Revenue 4Q +2.5% | FY +2.0% Revenue increased by 2.5% in 4Q25 with revenue per hl growth of 4.0% and by 2.0% in FY25 with rev
Bardasz Forms Strategic Digital Alliance with GEOLOG to Accelerate Global RTOC Delivery and Digital Well Construction Solutions12.2.2026 08:00:00 EET | Press release
Bardasz Group LLC (“Bardasz”), a provider of real-time, decision-ready intelligence for well construction—including drilling, completions, and well interventions—today announced a strategic digital alliance with GEOLOG International B.V. (“GEOLOG”), a global formation evaluation, drilling, and geochemistry services provider supporting subsurface projects in more than 40 countries. The alliance is designed to accelerate Bardasz’s global growth and enhance customer delivery by leveraging GEOLOG’s in-country resources, technical expertise, and operational scale. Bardasz helps operators transform fragmented well construction data into actionable intelligence across assets—enabling faster integration, increased reliability of real-time data workflows, and improved rig-time efficiency with reduced non-productive time (NPT). Bardasz’s high-frequency real-time well construction platform is built on best-in-class WITSML and ETP standards and is engineered for scaled, enterprise-grade environmen
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