C-LECTA
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
Kioxia Develops Core Technology that Will Allow the Practical Implementation of High-density, Low-power 3D DRAM12.12.2025 06:24:00 CET | Press release
Showcase the technology of highly stackable oxide-semiconductor channel transistors Kioxia Corporation, a world leader in memory solutions, today announced the development of highly stackable oxide-semiconductor channel transistors that will enable the practical implementation of high-density, low-power 3D DRAM. This technology was presented at the IEEE International Electron Devices Meeting (IEDM) held in San Francisco, USA, on December 10, and has the potential to reduce power consumption across a wide range of applications, including AI servers and IoT components. In the era of AI, there is growing demand for DRAM with larger capacity and lower power consumption that can process large amounts of data. Traditional DRAM technology is reaching the physical limits of memory cell size scaling, prompting research into the 3D stacking of memory cells to provide additional capacity. The use of single-crystal silicon as the channel material for transistors in stacked memory cells, as is the
Andersen Global styrker sine juridiske kapaciteter med tilføjelsen af brasiliansk medlemsfirma11.12.2025 18:49:00 CET | Pressemeddelelse
Andersen Global udbygger sin juridiske platform i Brasilien, da Lotti e Araújo bliver et medlemsfirma, hvilket styrker organisationens kapacitet i Latinamerika. Lotti e Araújo blev stiftet for over 20 år siden og tilbyder omfattende juridisk rådgivning til brasilianske og multinationale klienter inden for en lang række brancher. Dets tværfaglige praksis omfatter selskabsret, skatteret, arbejdsret, retssager, inkasso og inddrivelse af gæld – samt specialiseret arbejde med at identificere skjulte aktiver og inddrive anke- og retsindskud i ældre sager. Firmaet håndterer også voldgift, forvaltningsret, udenlandske investeringer, fast ejendom, intellektuel ejendomsret, databeskyttelse og virksomhedsomstrukturering og tilbyder juridisk assistance inden for selskabsdannelse og repræsentation over for tilsynsmyndigheder. Teamet rådgiver klienter om forebyggende juridiske strategier og komplekse tvister for administrative organer og domstole i Brasilien. "Hos Lotti e Araújo bygger vores praksis
BEYOND Developments Reveals a New Vision for Purposeful Living on Dubai Islands with SIORA11.12.2025 18:02:00 CET | Press release
A 2M sqft masterplan inspired by Japanese garden principles, crafted around balance, clarity, and the quiet rhythm of coastal life BEYOND Developments, the bold and design-led real estate developer shaping next-generation waterfront destinations in the UAE, today unveiled SIORA, its first beachfront masterplan on Dubai Islands and the company’s second large-scale community within a year. The launch underscores BEYOND’s accelerated growth and strong alignment with Dubai’s future urban vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211014389/en/ BEYOND Developments - SIORA Masterplan at sunset - Dubai Islands (Photo: AETOSWire) Spanning over 2M square feet, SIORA is conceived as a coastal sanctuary inspired by Japanese garden philosophies, including the pursuit of Ikigai, the Japanese concept of finding purpose and fulfilment in everyday life. In this context, it reflects a philosophy of creating spaces that bring c
3Degrees Welcomes David Dines to Board of Directors11.12.2025 17:00:00 CET | Press release
3Degrees, a global leader in renewable energy and climate solutions, is pleased to announce the appointment of David Dines to its Board of Directors, effective December 8, 2025. Dines brings more than four decades of leadership experience across global energy, commodities, financial services, transportation, and industrial markets. He served on the executive team as Chief Financial Officer and Corporate Senior Vice President at Cargill, Inc., the largest privately held company in the United States, where he oversaw enterprise-wide financial strategy, capital deployment, and financial performance. During his 29-year career at Cargill, Dines led multiple global businesses, played key roles in major technology and process transformations, and was a member of Cargill’s Commodity Risk, Financial Risk, and Process, Data, and Technology Committees. “We are thrilled to welcome David to the 3Degrees board,” said Philippe Vedrenne, CEO, 3Degrees. “He has an exceptional command of financial stewa
ITC Infotech wins PTC Partner Network Award for FY25 in the PLM Category11.12.2025 15:40:00 CET | Press release
ITC Infotech’s DxP Services earns recognition for its strong PLM expertise, unwavering commitment to delivering customer value, and strategic collaboration with PTC to drive innovation through SaaS-led offerings and accelerate digital transformation for customers. ITC Infotech, a leading global technology services and solutions provider, has been awarded the PTC Partner Network Award for FY25 in the Product Lifecycle Management (PLM) category. This prestigious recognition, awarded to a single partner globally, celebrates excellence in deploying Enterprise PLM software, enabling global and cross-functional teams to effectively manage product data and providing a trusted system for product information. The award underscores ITC Infotech’s leadership in PLM-led digital transformation, as well as its strategic alignment with PTC’s Intelligent Product Lifecycle vision, which helps customers build a structured product data foundation that serves as the backbone for AI-driven transformation.
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