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
Ant International’s Alipay+ Connects Argentina's National QR Payment Scheme via PVS,Enabling for Cross-Border Digital Payment Nationwide at Millions of Merchants17.7.2026 12:17:00 CEST | Press release
Alipay+, a global digital payment gateway under Ant International, today announced that it will enable global travellers to make QR code payments at millions of merchants across Argentina through integration with the country's national QR payment scheme Transferencias 3.0, in partnership with PVS, a fintech company specialized in developing customized payment solutions in Latin America. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260717276406/en/ By connecting to Argentina's national QR payment scheme, Alipay+ now enables global travellers in the country to make convenient QR code payments at merchants nationwide. This service helps to enhance global travellers' travel experiences in Argentina, allowing them to pay seamlessly at restaurants, malls and tourist attractions. Using an Alipay+ partner payment app, they can now scan the national QR code displayed at all merchants to make cross-border payments across Argentina,
KATE Launches "KABUKE: Break Convention" Kabuki-Inspired International Campaign17.7.2026 09:00:00 CEST | Press release
Where “NO MORE RULES.” intersects with the Kabuku spirit. Inspired by Japanese aesthetics, KATE shares the value of shadow enhancing makeup and self‑expression with the world. Global cosmetics brand KATE launched “KABUKE: Break Convention,” a new international campaign drawing on elements of Kabuki, the traditional Japanese performing art. The campaign debuted on Wednesday, July 8, 2026. In this campaign, KATE’s shadow enhancing makeup—rooted in Japanese aesthetics—was paired with the Kabuki spirit inherited from traditional Kabuki theater to communicate the value of individuality and self‑expression through makeup on a global scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708829427/en/ KATE international campaign “KABUKE: Break Convention” key visual. Dedicated website: https://www.kate-global.net/my/special/kate_kabuki/ Since its founding, KATE has championed the slogan “NO MORE RULES.,” offering makeup that defi
Meiji Seika Pharma: Results from the Global Phase III Trial (Integral-2) of Nacubactam, a Novel β-Lactamase Inhibitor, Highlighted in The Lancet Microbe’s Coverage of ESCMID Global Congress 202617.7.2026 03:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Toshiaki Nagasato) today announced that results from the global Phase III trial (Integral-2) of nacubactam (Development Code: OP0595), a novel β-lactamase inhibitor, were highlighted in The Lancet Microbe’s coverage of ESCMID Global Congress 2026 (held in Munich, Germany). As highlighted in The Lancet Microbe’s coverage, the key findings presented by Meiji Seika Pharma at ESCMID Global Congress 2026 are as follows: The Integral-2 study (jRCT2031230076) is a global Phase III clinical trial that enrolled patients with complicated urinary tract infections, acute uncomplicated pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, or complicated intra-abdominal infections caused by carbapenem-resistant Gram-negative bacteria (excluding Acinetobacter species). The study has achieved the prespecified study objectives. For the primary endpoint of overall treatme
Yoshihiro Shimamura Joins the Marché du Film’s “Investors Circle 2026” as an Invited Investor, Backing a New Feature Film17.7.2026 03:00:00 CEST | Press release
Shimamura Yoshihiro Film Production Co., Ltd. (Head office: Osaka, Japan; Representative Director: Yoshihiro Shimamura), a company active in film production and investment, today announced that Representative Director Yoshihiro Shimamura has decided to invest in an international feature film after being invited to the “Investors Circle 2026” — a distinction that reflects his standing as one of the field’s most highly regarded producers and investors. Hosted by the Marché du Film, the business arm of the Festival de Cannes and one of the world’s largest film markets, the Investors Circle is an invitation-only summit that connects a select group of private investors with high-end feature films during early-stage financing. Held in Cannes, France, May 16-17, 2026, it brings internationally acclaimed directors and producers together with investors around a curated slate of projects in development. During the summit, Shimamura attended private pitching sessions and, after individual meeting
Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies17.7.2026 00:00:00 CEST | Press release
On average, about 75% of patients with scalp psoriasis treated with zasocitinib achieved clear or almost clear skin at week 16 Approximately 70% of patients with palmoplantar disease treated with zasocitinib achieved clear or almost clear skin at week 16 Zasocitinib demonstrated statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo Results reinforce the potential of zasocitinib to deliver rapid and durable skin clearance, including in the hardest-to-treat areas, in a convenient once-daily pill Takeda (TSE:4502/NYSE:TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, these secondary endpoint data show that zasocitinib demonstrated consistent and high rates of skin clearance across hard-to-
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