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
TOURISE and Oxford Economics Release New Global Report on Tourism Resilience in an Era of Permanent Disruption17.8.2026 16:33:00 CEST | Press release
New analysis shows destinations that assume risk will recover up to 1.5 times faster with global rehabilitation times dropping from 24 months to as little as 10 TOURISE, in collaboration with Oxford Economics, today released a new report, “Resilience in a World that Doesn’t Reset: Redesigning Tourism for an Era of Permanent Disruption.” The analysis of 85 major crises over two decades shows a clear pattern: in a world defined by continuous shocks, destinations that act before disruption hits recover up to 1.5 times faster than those that wait. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260817880835/en/ “In a world that does not reset between crises, disruption is a constant feature of the global tourism landscape,” said His Excellency Ahmed Al-Khateeb, Minister of Tourism of Saudi Arabia and Chairman of TOURISE. “The real test for destinations measures how they prepare for volatility, protect traveler confidence, and mai
The Expensify Visa® Commercial Card Brings New Proactive Spend Controls to 14 Countries17.8.2026 15:00:00 CEST | Press release
New admin-defined spend rules let businesses control how, where, and when every card is used, stopping the wrong spend before it happens instead of cleaning it up after. Expensify, Inc. (Nasdaq: EXFY), the easiest way to manage expenses, travel, and corporate cards, today expanded the reach of Expensify Card spend rules, the market-leading way for businesses to control corporate card spend before it happens. Available to businesses in 14 countries, spend rules let admins decide exactly how, where, and when each Expensify Card can be used, so only compliant transactions go through. Unlike traditional corporate cards that rely on after-the-fact expense review, the Expensify Card enforces policy at the point of purchase. Admins set the rules once, and the card handles the rest. With Expensify Card spend rules, admins can: Lock a card to a subscription. Give each recurring SaaS tool its own virtual card, so a vendor can only ever charge what it should. If the card owner changes teams or le
Riskified Analysis Finds Travel Fraudsters Are Adapting Faster Than Traditional Signals Can Keep Up, With May Flight Risk Up 32%17.8.2026 14:30:00 CEST | Press release
New Travel Industry report reveals sophisticated fraud rings are exploiting trusted customer behaviors across flights, hotels, and travel platforms Riskified (NYSE: RSKD), a global leader in ecommerce fraud and risk intelligence, today released new findings from its Travel Industry Insights report, revealing how sophisticated fraud rings and AI-enabled fraudsters are evolving their tactics across airlines, hotels, and online travel platforms. Riskified’s analysis shows that fraudsters are increasingly adapting their behavior to resemble legitimate travelers, making traditional fraud indicators less reliable and creating new challenges for travel merchants. Riskified’s analysis of hundreds of millions of travel transactions across flights, hotels, and land transportation found that flight fraud risk increased through the first five months of 2026, with May 2026 marking the sharpest year-over-year increase at 32% compared to May 2025. The findings show that sophisticated fraud activity i
PIF Delivers Strong Revenue and Profit Growth in 202517.8.2026 13:54:00 CEST | Press release
Revenue rose 9% to $120 billion while net profit more than doubled to $17 billionCumulative domestic investments reached more than $199 billion since 2021PIF has contributed more than $342 billion to Saudi Arabia’s real non-oil GDP between 2021 and 2025Assets under management exceed $900 billion, up from around $530 in 2021 and $150 billion in 2015 PIF today published its 2025 Annual Report demonstrating strong financial performance and continued progress against its long-term objectives. As a long-term investor with a unique mandate to drive the economic transformation of Saudi Arabia and deliver sustainable financial returns, PIF maintained a diversified portfolio in 2025, balancing returns with national impact and long-term resilience. Maintaining Financial Discipline In 2025, revenue rose 9% year on year to $120 billion, while net profit more than doubled to $17 billion, supported by stronger contributions from maturing portfolio companies. PIF retained over $900 billion in assets
Foundever Successfully Closes a Holistic Recapitalization, Reducing its Debt by Nearly $900 Million and Strengthening its Financial Position for Long-Term Growth17.8.2026 13:30:00 CEST | Press release
Secures $225 Million Equity Infusion; Revolving Credit Facility and Term Loan Maturities ExtendedBenoit Leclercq Appointed Interim Chief Executive Officer to Lead Foundever Through its Next Phase of Growth; Company Begins Formal Search Process for Permanent CEO Foundever Group S.A.® (“Foundever” or the “Company”) – a global leader in integrated customer experience, digital operations and analytics services, today announced that it has successfully closed a holistic recapitalization (the “Transaction”) in coordination with 95.4% of the lenders under its term loan facility (“Term Loan Lenders”), 100% of its revolving credit facility lenders (“RCF Lenders”), and the Company’s existing majority shareholders. The Transaction meaningfully strengthens Foundever’s financial foundation and positions the Company to invest in its growth strategy. Key terms of the Transaction include: Company's existing majority shareholders invest $225 million into common equity. Term loan facility exchange reduc
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