c-LEcta: Drug Master File for the Use of the Enzyme DENARASE® in the Pharmaceutical Industry Accepted by the US FDA
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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Phone: +49 (0) 611 - 205855 – 64
Fax: +49 (0) 611 - 205855 – 66
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
2J Antennas Launches The World’s Smallest 5GNR, WiFi-6E and GNSS Combination 9-in-1 Antennas For Critical Communication Modernization23.9.2021 17:50:00 EEST | Press release
2J Antennas, a global leader in high performance antenna solutions, introduces the new Stellar Series that is designed for a large suite of devices with a focus on sub 6 GHz, 5G NR, 4G LTE, 3G, 2G, WiFi-6E and GNSS technologies. With superior reliability, quality, performance, real time connectivity and smaller size, the Stellar Series caters to law enforcement, medical transportation, fire rescue, and any other applications where mission critical communication is a requirement. This series includes single or up to 9-in-1 configuration choices within the range of 617 MHz to 7125 MHz frequency bands. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210923005703/en/ Stellar Series by 2J Antennas (Photo: Business Wire) The cutting-edge patent pending technology reduces the antenna footprint by 55% while implementing a new double trifilar design and longitudinal resonances for MIMO/ ARRAY configurations that traditionally have mor
Saladax Biomedical Announces Salvatore J. Salamone, Ph.D. Received the Prestigious Dr. C.E. Pippenger Award23.9.2021 17:05:00 EEST | Press release
Salvatore J. Salamone, Ph.D. received the prestigious Dr. C.E. Pippenger Award at the 2021 International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) annual meeting in Rome, Italy. This award is given to individuals who have made outstanding contributions to the field of Therapeutic Drug Monitoring (TDM). TDM is a field of medical science that seeks to ensure that patients receive a personalized dose of drugs to achieve an optimum therapeutic result. Unfortunately, many medications, such as anticancer, antibiotics, and antifungal treatments, have severe toxicities when overdosed and are ineffective when underdosed. TDM seeks to ensure that the patient receives enough drug to treat the condition but not too much to cause toxicities and potentially death. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210923005035/en/ Dr. Salvatore J. Salamone (Photo: Business Wire) Dr. Salamone received this aw
HarbourVest Partners Announces Close of Direct Lending Fund23.9.2021 17:00:00 EEST | Press release
HarbourVest Partners, a global private markets asset manager, today announced the final close of its HarbourVest Direct Lending Fund (HDL) at over $892 million in limited partner commitments, including the General Partner commitment. The Fund was oversubscribed and closed above the target size of $600 million. This close follows the firm’s final close of Credit Opportunities Fund II, HarbourVest’s junior credit offering, earlier this year. “We are pleased to mark the final close of our inaugural, dedicated direct lending fund, bringing our total capital under management for credit investments to over $3.3 billion*,” said John Toomey, Managing Director, HarbourVest Partners. “The past year has demonstrated the resilience of the asset class and reinforced our objective to broaden the reach of HarbourVest’s solutions to help clients invest in rapidly growing strategies.” The Fund targets senior credit investments in private equity-backed middle-market companies, predominantly in North Ame
Belam and Cepton Establish Partnership to Enable Safety at High-traffic Railway Level Crossings23.9.2021 17:00:00 EEST | Press release
Cepton, a Silicon Valley-based innovator of smart lidar solutions has teamed up with Lithuania-based system integrator Belam to improve road user and rail passenger safety by deploying lidar-enabled obstacle detection at railway level crossings. Following the installation of Cepton’s Helius® Smart Lidar System at a busy railway intersection in Europe, the lidar-based solution has monitored over 15,000 train passages with high accuracy to help ensure the safety of pedestrians and other road users. The system has also helped improve the efficiency of the train service and the traffic flow where it is deployed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210923005369/en/ Cepton's lidar sensors are installed at the busy level crossing to monitor a complicated traffic scenario. ©Belam. Photo Credit: Belam Belam is a full-service system integrator operating in the Baltics and Northern Europe. Utilizing cutting-edge technologies
NuScale Power Signs Memorandum of Understanding with KGHM and PBE to Explore SMR Deployment in Poland23.9.2021 16:45:00 EEST | Press release
NuScale Power, KGHM Polska Miedź S.A. (KGHM), and Piela Business Engineering (PBE) announced today the three companies have signed a Memorandum of Understanding (MOU) to explore the deployment of NuScale’s small modular reactor (SMR) technology as a coal repurposing solution for existing coal-fired power plants and electricity and heat for KGHM’s industrial processes in Poland. KGHM is a Poland-based leader in copper and silver production and PBE is a Poland-based consultancy which specializes in business engineering advisory. This agreement demonstrates international interest in utilizing NuScale’s SMR technology to produce clean, reliable, and affordable energy. Under the MOU, NuScale will support KGHM and PBE’s examination of NuScale’s SMR technology as a coal repowering/repurposing solution for existing coal-fueled power plants and more broadly for new nuclear plant implementations, as well as for energy in support of industrial operations in Poland. The examination will include an
Allegro DVT and Beamr Announce the World’s First Content-Adaptive Silicon IP Video Encoder23.9.2021 16:35:00 EEST | Press release
Allegro DVT, the leading provider of video processing silicon IPs, and Beamr, the leading developer of content-adaptive video encoding technologies, today announced an integrated solution that combines Beamr’s CABR silicon IP with Allegro’s video encoding IP to create the world’s first content-adaptive silicon IP encoder. Using the integrated solution, ASIC vendors can now create high-performance, low latency video encoding chips that significantly reduce video bitrate without compromising quality. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210923005015/en/ (Photo: Allegro DVT) Allegro DVT’s E2xx family of silicon proven IPs is a highly optimized video encoding solution targeted at ASIC implementations in a wide range of process node technologies down to 3nm. It provides support for mainstream image and video formats including JPEG, H.264, HEVC, VP9 and AV1, at up to 8K resolutions. Beamr’s patented, Emmy® award-winning
Nexo Passes Real-Time Reserves Audit Conducted by Armanino23.9.2021 16:30:00 EEST | Press release
Nexo, the leading institution for digital assets, today announced that Armanino LLP – a PCAOB-certified auditor and one of the 25 largest public accounting firms in the U.S. – now provides a real-time audit of Nexo’s assets, thus offering unparalleled visibility into Nexo’s finances and showing that the company’s assets exceed its liabilities at all times. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210923005619/en/ A snapshot of Nexo's assets and liabilities as of September 23, 2021. (Graphic: Business Wire) Armanino’s real-time attestation of Nexo’s assets and customer obligations brings a level of customer security unprecedented in the crypto lending space. The independent audit also represents a significant milestone in Nexo’s transparency and compliance journey and marks only the beginning of a routine Proof of Reserves program. The next step will allow each client to verify for themselves that their particular asset
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