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
Boyd Watterson Global Names John Creswell Global Chief Client Officer to Accelerate Global Growth and Client Engagement23.7.2026 15:00:00 CEST | Press release
Veteran investment management executive will lead global sales, client engagement and marketing as Boyd Watterson Global continues expanding its global alternatives platform across real estate, infrastructure, and debt strategies. Boyd Watterson Global today announced the appointment of John Creswell as Global Chief Client Officer, a newly created senior leadership role that reflects the firm's continued investment in growth and its evolution into a leading global alternatives investment platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722823117/en/ John Creswell has joined Boyd Watterson Global as Global Chief Client Officer, a newly created role overseeing global sales, client engagement and marketing across the U.S., Europe and APAC. In this role, Creswell will oversee global sales, client engagement and marketing efforts across the United States, Europe and APAC, helping investors access the firm's capabilitie
Trulioo Launches AI Agent to Resolve Beneficial Ownership Where Global Registries Fall Short23.7.2026 15:00:00 CEST | Press release
Breakthrough AI agent reconstructs ownership for long-tail businesses and hard-to-reach jurisdictions while significantly increasing UBO coverage Trulioo, a global risk intelligence platform, today announced the UBO Discovery Agent, the newest layer in Trulioo's UBO Discovery capability inside its business risk and Know Your Business (KYB) verification workflow. AI is reshaping fraud, making it easier for bad actors to hide, and harder for companies to catch them. This makes the already tough job of verifying who actually owns a business even more difficult. Determining a business's ultimate beneficial owner is an ongoing, acute challenge for companies: registry coverage is inconsistent across countries, and even where registries exist, they typically record shareholders and directors of record (rather than the people actually in control). That data isn't simply outdated, it reflects a structural lag: ownership changes and time passes before the filing is made and processed, so a looku
Humanoid Raises $152 Million at $1.35 Billion Post-Money Valuation, Becoming Europe's First Pure-Play Humanoid Robotics Unicorn23.7.2026 15:00:00 CEST | Press release
Humanoid announces its Series A investment round, reaching a $1.35 billion valuation just two years after founding.It is the largest ever Series A for a humanoid-first robotics company in Europe, positioning Humanoid as the leading humanoid-first robotics unicorn in the UK and continental Europe.The new capital will accelerate Humanoid's next-generation robot development, commercial deployments with global industrial leaders, and evolution of the proprietary AI platform on the path toward general-purpose humanoids.The investment marks a defining moment for Europe's tech ecosystem, showing that globally competitive Physical AI companies can be built and scaled in Europe. Humanoid, a UK-based AI and robotics company building industrial humanoid robots, announced a $152 million Series A financing at a $1.35 billion post-money valuation. This funding brings the total amount raised to date to $270 million. The round was led by Prime Movers Lab, a venture capital firm focused on investments
Riskified Named to the CNBC World's Top Fintech Companies 2026 List23.7.2026 14:00:00 CEST | Press release
Payment category recognition marks Riskified's continued presence among the world's leading fintech innovators Riskified (NYSE: RSKD), a global leader in ecommerce fraud detection and risk intelligence, has been named to CNBC's World's Top Fintech Companies 2026 list, in the Payments category. The list, now in its fourth edition, is produced by CNBC in partnership with Statista Inc., the global statistics and industry ranking firm. It was announced on July 22, 2026, and is available on CNBC's website. This is Riskified's second time making the list. The company previously earned this recognition in 2024, reinforcing its position in the ecommerce fraud and risk intelligence sector and underscoring its ongoing success in empowering businesses to grow revenue and profitability by mitigating risk through its AI-powered platform. CNBC and Statista's ranking covers the top 500 companies across eight fintech segments — Payments, Neobanking, Alternative Financing, Wealth Technology, Digital As
Azafaros Completes Enrollment of Phase 3 (NAVIGATE) Study Evaluating Nizubaglustat for the Treatment of Patients with GM1/GM2 Gangliosidoses23.7.2026 13:00:00 CEST | Press release
NAVIGATE comprises two pivotal Phase 3 studies investigating nizubaglustatRecruitment completed in Phase 3 registrational study in patients with late-infantile and juvenile GM1/GM2 gangliosidosesEnrollment in Niemann-Pick type C disease (NPC) Phase 3 study is ongoingTopline data from GM1/GM2 gangliosidoses Phase 3 study is anticipated in early 2028 Azafaros, a private company building a portfolio of disease-modifying therapeuticsto become a leader in lysosomal storage disorders (LSDs) focused on addressing neurological symptoms, today announced the completion of patient recruitment in its Phase 3 study evaluating nizubaglustat for the treatment of GM1/GM2 gangliosidoses. “Completing enrollment in our Phase 3 GM1/GM2 study is a significant step toward potentially bringing nizubaglustat to patients and families living with these devastating neurodegenerative diseases," said Stefano Portolano, Chief Executive Officer at Azafaros. "We are deeply grateful to the patients, caregivers, invest
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