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
ProcureTEX Returns for Its Second Year, Bringing AI and Best-of-Breed Procurement Technology to Amsterdam14.10.2026 18:26:00 CEST | Press release
Founding partners Beroe, Keelvar and Zip bring back the community-driven event with a practitioner-shaped agenda spanning real-world AI use and the future of procurement ProcureTEX, the community-driven event for best-of-breed procurement technology, returns for its second year on November 3, 2026, at Circa in Amsterdam. Following its London debut in 2025, the event sharpens its focus on how AI is reshaping procurement. It will bring together over 250 procurement leaders and digital transformation teams from large enterprises, with vetted best-of-breed technology providers, to see AI agents and interoperable tools working together on real enterprise challenges. Co-founded by Beroe, Keelvar and Zip, the event is built on the belief that the future of procurement isn’t a monolithic all-in-one suite, but an ecosystem of best-of-breed tools working together. It is designed for procurement and enterprise leaders seeking scalable, modern solutions, whether they’re driving transformation, fru
eM Client 11 Launches: A European Outlook Alternative Bringing AI Freedom, Digital Sovereignty, and Next-Generation Productivity14.10.2026 18:16:00 CEST | Press release
eM Client, the European developer of the popular email and productivity application used by millions worldwide, today announced the release of eM Client 11, its most significant update yet. The new version introduces advanced AI capabilities, and major productivity improvements, strengthening its position as an independent alternative to Microsoft Outlook. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014945464/en/ eM Client 11 main window AI Without Vendor Lock-In eM Client 11 introduces a powerful AI Assistant that enables users to search, summarize, organize, and manage emails using natural language. Additional features include personalized AI writing, context-aware quick replies, automatic task and event detection, and AI-powered email rules. Unlike traditional AI integrations, eM Client 11 supports Bring Your Own Key (BYOK), allowing organizations to connect compatible AI providers and models of their choice. The re
iQmetrix and Stratus HR Partner to Give Wireless Retailers a Complete, Outsourced HR Department14.10.2026 17:15:00 CEST | Press release
New integration connects the employee lifecycle to the store – new hires, terminations, rehires, position moves, and security-role updates flow straight into the POS, with payroll, benefits, and compliance handled by Stratus HR’s certified experts. Stratus HR, a full-service human resources outsourcing provider, today announced a partnership with iQmetrix, the Intelligent Commerce Operating System for telecom. As a Professional Employer Organization (PEO), Stratus HR becomes the complete, outsourced HR partner for wireless retailers on iQmetrix – payroll, benefits, compliance, and on-call HR experts – so retail teams stay focused on selling and serving customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014178512/en/ Fully integrated with iQmetrix, Stratus HR’s custom-built technology connects the employee lifecycle to the store: new hires, terminations, rehires, position moves, and security-role updates flow straig
New Study Brings Ketogenic Therapy for Bipolar Disorder Directly to Rural Alabama Homes14.10.2026 17:00:00 CEST | Press release
Leveraging Alabama’s agricultural strength, a new Baszucki Group-funded pilot study uses food bank delivery to expand metabolic psychiatry research into resource-poor rural areas Baszucki Group today announced funding for a clinical study to examine the impact of ketogenic therapy on people living with bipolar disorder in rural Central Alabama. This study, led by researchers at the University of Alabama at Birmingham Heersink School of Medicine Montgomery Regional Campus, will partner with Heart of Alabama Food Bank (HAFB), sourcing Alabama-raised meats and produce to introduce metabolic psychiatry to a region characterized by a high prevalence of serious mental illness and severe shortages in psychiatric care. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014955753/en/ A new study led by Will Rutland of UAB Montgomery and funded by Baszucki Group aims to improve access to psychiatric treatment in rural areas. By partner
Ant International Obtains Key Licenses from the Central Bank of the UAE to Support Digital Payments in the AI Era14.10.2026 16:32:00 CEST | Press release
Ant International, a leading global provider of digital payments and financial technology, has secured a Retail Payment Services and Card Schemes (Category II) (RPSCS) license and Stored Value Facilities (SVF) license from the Central Bank of the UAE (CBUAE), aligning with the UAE’s broader agenda for innovation and digital transformation in the financial sector. “The RPSCS and SVF licenses mark a crucial milestone in Ant International’s efforts to support the UAE’s fintech ecosystem, aligning with the nation’s ‘We are UAE 2031’ digitalisation and fintech strategy,” said Leiming Chen, Chief Sustainability Officer and Senior Vice President of Ant International. “In accordance with the applicable CBUAE regulatory framework, we look forward to launching AI-powered global payment and account solutions to make cross-border payments and financial management more accessible." Obtaining the RPSCS license is an important step towards Antom, a leading merchant payment and digitisation services p
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