C-LECTA
31.8.2021 09:02:05 CEST | 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210831005367/en/
About Business Wire
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
GenNx360 Capital Partners Promotes Pratik Rajeevan to Partner17.6.2026 13:00:00 CEST | Press release
GenNx360 Capital Partners (“GenNx360”), a New York City-based private equity firm investing in U.S. lower middle market industrial services and business services companies, is thrilled to announce the promotion of Pratik Rajeevan to Partner. Pratik has significant transaction experience having invested in over ten platform companies and 30 add-on investments during his tenure at GenNx360. His experience includes investments in aerospace and defense, utility and environmental services, and testing and inspection services. Pratik is a key leader in investments in NVI, Shenandoah, and Aeron in the GenNx360 Fund IV portfolio. Pratik led successful investments and exits in Miller Environmental and Aero3 in GenNx360 Fund III. Most recently, Pratik was responsible for the firm’s $2 billion exit from Precision Aviation Group, a global aerospace and defense maintenance and repair business in GenNx360 Fund IV. “Pratik is a disciplined and thoughtful investor with significant execution capabiliti
Vercel Brings New Agent Framework, Full-Stack Capabilities, and Enterprise Controls to Its Agentic Infrastructure Platform17.6.2026 12:13:00 CEST | Press release
As agents become the primary way software is built and deployed, Vercel connects its frontend, backend, and agent tooling into a single platform for shipping and running agents at scale. Today at Ship, its annual conference, Vercel introduced a set of new products that deepen its agentic infrastructure platform trusted by DoorDash, Helly Hansen, OpenAI, Stripe, and The Weather Company. Founder and CEO Guillermo Rauch and other Vercel leaders unveiled the lineup on stage, anchored by three shifts the products address: agents are now the dominant way software gets deployed, every application is becoming agentic, and enterprises need to run agents in production securely and at scale. The transition is well underway. Six months ago, fewer than three percent of deployments to Vercel infrastructure were triggered by coding agents. Agents now account for more than half. Token volume through Vercel's AI Gateway has grown from roughly two trillion to twenty trillion per month over the same peri
NIQ Introduces NIQ Cadence: A Compound AI Operating System for Marketing Effectiveness17.6.2026 12:00:00 CEST | Press release
One system unifies NIQ’s global data, models, and knowledge so marketers move from insight to impact faster, with deeper intelligence, at scale. NIQ (NYSE: NIQ), a global leader in consumer intelligence, today introduced NIQ Cadence, a compound AI operating system built to change how organizations measure marketing performance, optimize budgets, and act on what the data tells them. NIQ Cadence brings data and intelligence into one continuous environment, moving marketers off fragmented reports and onto a single system that empowers decision making. Marketing has never been more complex. Channels keep multiplying, data sits in silos, and the pressure to prove ROI keeps climbing. As a result, most teams still stitch insight and action together by hand, losing time and confidence at every handoff. NIQ Cadence closes that gap with one system where measurement and decision-making finally run together. “Marketing leaders don’t need more reports. They need a better rhythm,” said Jason Tate, G
Winning With AI Requires Organizational Transformation, Not Speed of Adoption, Finds New Arthur D. Little Report17.6.2026 12:00:00 CEST | Press release
To successfully embrace the power of AI, businesses need to remove organizational complexity and eliminate unnecessary work, rather than simply using it for fragmented, incremental improvements. Boards must act now to deliver this. That is the key message from AI-First or Disrupted: Beating the Nightmare Competitor, a new report from Arthur D. Little (ADL) based on concrete examples from leading organizations. Within three to five years, AI-first competitors will make faster decisions, have flatter organizations, and operate at lower costs. They will not just optimize handovers between teams, approvals, and reconciliation work; they will eliminate these complex processes entirely. AI is completely changing the economics of work and value creation, removing the need for coordination across multiple teams, while also enabling adaptive, predictive, and personalized products and services. This delivers both lower operational costs and a fundamentally stronger value proposition. However, mo
WISE Closes Oversubscribed Series D Financing Round of €30 Million, Welcoming ENEA Tech and Biomedical as Strategic New Investor17.6.2026 12:00:00 CEST | Press release
WISE S.p.A., a pioneering medical device company specializing in advanced implantable electrodes for neuromonitoring, neuromodulation, and brain-computer interface (BCI), today announced the successful closing of an oversubscribed Series D financing round totaling €30 million. The round was joined by ENEA Tech and Biomedical, an Italian foundation dedicated to innovation and technology transfer in the biomedical sector, which enters WISE's investor base as a strategic partner. This final closing builds on the first closing of the round completed in June 2024, which included a venture debt facility from the European Investment Bank (EIB) supported by InvestEU, alongside an equity investment from new investor Wallaby S.p.A. — the family office of the Scagliarini family (GVS S.p.A.) — and existing financial partners New Frontier S.r.l., Eureka Venture SGR, and Indaco Ventures SGR. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20
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