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
Allianz Delivers Record Result and Is Well on Track to Achieve Its Targets7.8.2026 07:10:00 CEST | Press release
2Q 2026 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806509750/en/ Oliver Bäte, Chief Executive Officer of Allianz SETotal business volume at 45.6 billion euros, an internal growth of 5.7 percent1, with contributions from all segments. Asset Management delivers excellent growth. Operating profit rises 10.6 percent to a record level of 4.9 billion euros. Shareholders’ core net income at 2.6 billion euros; 12.7 percent below last year. Adjusted for a divestment gain last year and offsetting measures following the sale of the stake in our Indian JVs, underlying growth is strong at 10 percent. 6M 2026Total business volume at 98.6 billion euros, an internal growth of 4.3 percent1, driven by Property-Casualty and especially Asset Management. Operating profit rises 8.6 percent and reaches a record level of 9.4 billion euros. Shareholders’ core net income advances 15.5 percent to 6.4 billion euros. Adjusted for divestment effec
Pure Lithium Receives Australian Patent for "Lithium Metal Anode and Battery"6.8.2026 22:49:00 CEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery technology company, today announced that the Australian patent office has granted the company a patent (AU2025271196) titled “Lithium metal anode and battery.” Australia mines roughly half of the world’s lithium, yet has no domestic battery production at all; every battery the country uses is imported. The granted patent is directed to ways in which Pure Lithium’s technology can change that. Rather than trying to catch up in lithium-ion, Australia can leapfrog the incumbent technology and establish a next-generation industry. As worldwide demand for batteries grows, every country capable of making batteries needs to be making them. That is Pure Lithium’s central goal: opening up markets around the world through battery technology that enables local, independent supply chains, keeping pace with demand and strengthening economies. China controls the lithium-ion battery supply chain and manufactures th
Vercel Appoints Amit Agarwal, Standard Template Labs CEO and former Datadog President, to Board of Directors6.8.2026 17:00:00 CEST | Press release
The product leader who helped scale Datadog from early-stage startup through IPO brings deep product expertise to Vercel's board Vercel, the agentic infrastructure company, today announced the appointment of Amit Agarwal, former president of Datadog and founder and CEO of Standard Template Labs, an AI-first service management platform, to its board of directors. Agarwal brings 25 years of enterprise software experience and a track record of scaling a product-led company from its earliest days into one of the defining public software companies of the cloud era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806738617/en/ Amit Agarwal Agarwal joined Datadog in 2012 as its Chief Product Officer and was named President in 2022, overseeing product, corporate development, and go-to-market functions as the company grew past $2.5 billion in annual revenue. Across 13 years, including Datadog's 2019 IPO and its first years as a pub
Laserfiche Launches Advanced Enterprise Security to Deliver Multi-Region Disaster Recovery and GovRAMP-Ready Compliance for Highly Regulated Industries6.8.2026 16:00:00 CEST | Press release
New security suite extends Laserfiche’s proven security controls and adds near real-time data replication for governments, law enforcement and security-conscious enterprises. Laserfiche — the leading SaaS provider of intelligent content management — today announced the launch of Enterprise Security, an advanced suite of security enhancements designed for organizations navigating complex regulatory environments. Enterprise Security addresses GovRAMP and CJIS (Criminal Justice Information Services) security requirements based on the NIST SP 800-53 framework. For organizations handling privileged citizen, legal or corporate data, these built-in controls streamline audit preparation and fortify defenses. With organizations placing a higher priority on data stewardship and corporate governance, enterprise IT leaders require a security architecture that protects data without slowing down operations. Laserfiche Enterprise Security extends Laserfiche Cloud’s highly resilient infrastructure wit
AM Best Upgrades Fortegra Insurance Subsidiaries to A (Excellent)6.8.2026 15:00:00 CEST | Press release
Rating actions follow completion of the DB Insurance acquisition The Fortegra Group, Inc. (“Fortegra” or the “Company”), a global specialty insurer and part of DB Insurance Co., Ltd., today announced that AM Best has upgraded the Financial Strength Rating (FSR) of its insurance subsidiaries to A (Excellent) from A- (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICRs) to “a” (Excellent) from “a-” (Excellent). The outlook assigned to the ratings is stable, and AM Best removed the ratings from under review with positive implications. KBRA has also upgraded all of its ratings for the Company. The upgrade applies across Fortegra’s insurance platform. The property and casualty companies include Lyndon Southern Insurance Company, Insurance Company of the South, Response Indemnity Company of California, Blue Ridge Indemnity Company, Fortegra Specialty Insurance Company and Fortegra Europe Insurance Company SE. The life and health companies include Life of the South Insurance Co
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