Business Wire

EXCiPACT Certification for c-LEcta’s High Production Standards

Share

c-LEcta, a global biotechnology company with technology leadership in enzyme engineering and bioprocess development, can significantly reduce the cost of supplier audits for customers thanks to its recent award of EXCiPACT certification. The certificate confirms compliance with particularly high quality standards in production and distribution. For customers from the pharmaceutical industry in particular, these standards are an important criterion for qualifying suppliers and the closure of contracts. The certification significantly eases cooperation with new and existing customers for c-LEcta. EXCiPACT certification is internationally recognized and confirms that c-LEcta complies with “Good Manufacturing Practice” and “Good Distribution Practice” for pharmaceutical excipients.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210302005046/en/

Inside c-LEcta's Leipzig production facility. (Photo: Business Wire)

Inside c-LEcta's Leipzig production facility. (Photo: Business Wire)

As a manufacturer of enzyme products for the food and pharmaceutical industries, c-LEcta places major importance on the highest quality standards in production and distribution. Customers, especially in the pharma industry, conduct audits regularly of their suppliers to verify their compliance with strict standards. As early as 2011, c-LEcta introduced an ISO 9001-certified quality management system that covers all areas of the company and also meets additional requirements for the internal manufacturing of products for the food industry. As EXCiPACT certification sets out further strict standards that can also be found in the corresponding U.S. standard ANSI NSF 363, cooperation with U.S. pharmaceutical customers will be facilitated as well.

Dr. Ramona Schmiedel, Head of Operations, explains: “Our EXCiPACT certification contributes to enhanced transparency and improved quality across the entire pharmaceutical value chain; it defines binding quality standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and combines them with ISO 9001 requirements. We therefore make a significant contribution to patient safety in the manufacture of our relevant products.

c-LEcta is subjected to regular detailed audits as part of its supplier qualifications, and we work tirelessly to continuously improve our processes. We are therefore proud of the EXCiPACT certification, which demonstrates our successful work in this area and makes our efforts visible to customers. While this does not mean our work is over, it does show that we are at the forefront. We will, of course, continue to invest in improving quality; this is a matter of course for us.”

The EXCiPACT certification program, launched by an international initiative of industry experts in January 2012, defines binding quality standards of GMP and GDP. EXCiPACT focuses on the production and distribution of pharmaceutical excipients and is internationally recognized in the pharma industry. The certificates therefore ensure transparency and improved quality. At the same time, they promote efficiency since recognized standards can be checked independently and fewer audits need to be repeated by customers. Following an extensive initial audit, surveillance audits are performed annually, followed by recertification after three years. In-depth tests and plant inspections are carried out on site.

As Dr. Marc Struhalla, founder and CEO of c-LEcta comments: “The highest quality standards are a very important requirement for the production of excipients and critical materials used by the pharmaceutical industry. Proving compliance with these standards can be a major time and cost factor in this and other areas. With EXCiPACT certification for certain products, such as DENARASE, it will be even easier for us to attract new customers in the future. The additional certification saves customers time and money and guarantees that they always offer patients the highest standard of quality. The EXCiPACT report also helps us to explain our quality management system to our customers in other markets and to inspire their trust.”

The certification was carried out by DQS GmbH, an independent certification body recognized by EXCiPACT. The EXCiPACT certification is valid for three years and includes annual surveillance audits.

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.

Contact information

cometis AG
Matthias Kunz
Phone: +49 (0) 611 - 205855 – 64
Fax: +49 (0) 611 - 205855 – 66
e-mail: kunz@cometis.de

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Advanced Eye Protection Against Covid-19 For Healthcare Professionals – an Exclusive Bollé Safety Technology16.4.2021 22:00:00 CEST | Press release

Bollé Safety, world leader in the design and manufacture of protective eyewear, presents its Healthcare division dedicated to all healthcare professionals. Its range of protective eyewear with anti-fog and anti-scratch PLATINUM® coating provides highly exposed employees with the highest levels of protection, clarity, and vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210416005009/en/ @BolléSafety - A.Childeric Viruses & infections’ protection Bollé Safety offers certified products compliant with the most stringent international standards. Its anti-fog PPE product range is tailored to protect professionals who are at high risk of being exposed to bodily fluids when providing care to patients. It is the company’s shared commitment to provide the highest quality protection for all healthcare workers. The importance of a clear vision Bollé Safety’s unique and exclusive permanent double sided anti-fog and anti-scratch PLA

Zeepay Ghana Acquires Mangwee Mobile Money in Zambia16.4.2021 19:55:00 CEST | Press release

Zeepay, the leading African Challenger Fintech with operations in over 10 African countries today acquired a 51 percent stake in Mangwee Mobile Money in Zambia. In a private placement Zeepay and Mangwee agreed to a sale of 51 percent of Mangwee shares to Zeepay. The deal makes Zeepay Ghana the majority shareholder of the entity. Mangwee has been in operations since 2018, and was initially set up to operate as an alternative wallet targeting university students in Zambia with the aim of assisting to drive the cost of mobile money services downward. Zeepay is the leading African challenger fintech with operations across 20 African countries and 30 day active in 10 of them. The company specializes in paying remittances into mobile money wallets across Africa and is regulated by both Bank of Ghana as an EMI issuer and in the UK as a Money Transfer Operator, by the Financial Conduct Authority. The merger is the first of its kind; that two Indigenous African fintechs into Mobile Money operat

CGTN: Leading With Action: China in the Fight for Carbon-Neutral Future16.4.2021 18:29:00 CEST | Press release

Climate change is not taking a break from wreaking havoc in 2020, with the joint highest global temperatures on record, rampant bushfires, the faster rates of sea level rise and the extinction of some species. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210416005435/en/ Under this circumstance, Chinese President Xi Jinping, French President Emmanuel Macron, and German Chancellor Angela Merkel held a virtual meeting Friday on climate change, ahead of the Leaders' Climate Summit on Earth Day convened by the U.S., scheduled next week. Emphasizing that he always advocates building a community with a shared future for mankind, the Chinese president voiced his willingness to strengthen cooperation with France and Germany on climate change. "Tackling climate change is a common cause for all mankind and it should not become a geopolitical bargaining chip, a target for attacking other countries, or an excuse for trade barriers," h

Colicity Inc. Announces the Separate Trading of its Class A Common Stock and Warrants, Commencing on or about April 16, 202116.4.2021 15:30:00 CEST | Press release

Colicity Inc. (the “Company”) announced that holders of the units sold in the Company’s initial public offering of 34,500,000 units, including the underwriters’ exercise of their full over-allotment option for 4,500,000 units, completed on February 26, 2021 (the “Offering”) may elect to separately trade the Class A common stock and warrants included in the units commencing on or about April 16, 2021. Any Units not separated will continue to trade on The Nasdaq Capital Market under the symbol “COLIU,” and the Class A common stock and warrants will separately trade on The Nasdaq Capital Market under the symbols “COLI” and “COLIW,” respectively. No fractional warrants will be issued upon separation of the units and only whole warrants will trade. Holders of units will need to have their brokers contact Continental Stock Transfer & Trust Company, the Company’s transfer agent, in order to separate the units into Class A common stock and warrants. This press release shall not constitute an o

Evobrutinib is the First and Only BTK Inhibitor to Demonstrate Reduction of a Key Biomarker of Neuronal Damage and Inflammation in Patients with MS16.4.2021 10:00:00 CEST | Press release

Merck, a leading science and technology company, will present data from a Phase II placebo-controlled randomized trial at the 2021 American Academy of Neurology (AAN) Annual Meeting showing that the investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib significantly reduced blood neurofilament light chain (NfL) levels, a key biomarker of neuronal damage and inflammation, in patients with multiple sclerosis (MS). Elevated blood NfL levels have been shown to be associated with damage to neurons and inflammation and may predict future brain atrophy and disease progression. “Blood NfL is a biomarker that may allow monitoring of disease activity and treatment response, which could be less burdensome and more sensitive than other standard clinical measures for MS patients,” said Prof. Jens Kuhle, MD, PhD, Head Multiple Sclerosis Centre, University Hospital Basel. “These data provide key insights into the role evobrutinib may play in modulating the clinical course of MS and fur

IFF Presents “Learning Labs” Video Series to Demonstrate Potential of New Company15.4.2021 22:15:00 CEST | Press release

IFF (NYSE: IFF) today introduced a new “Learning Labs” video series, featuring in-depth discussions with the leadership of the company’s segments and R&D function. Each video provides a comprehensive overview of IFF’s robust portfolio and enhanced capabilities following its recently completed merger with DuPont’s Nutrition and Biosciences (“N&B”) business. The complete “Learning Labs” series can be found here: ir.iff.com/events-presentations. In addition, IFF has also provided segment-level financial detail based on 2020 pro forma results. “As a global industry leader of high-value consumer ingredients, we are pleased to provide a closer look into our capabilities, operational model and future growth potential,” said Andreas Fibig, IFF Chairman and CEO. “Stakeholder communication remains essential to IFF’s continued growth, and since combining with N&B, we have continued to explore new ways to meaningfully connect with our investors. The insights shared through our ‘Learning Labs’ seri

Algorand and BridgeTower Capital Announce Strategic Partnership15.4.2021 22:14:00 CEST | Press release

BridgeTower Capital, a global private equity firm, focusing on traditional private equity investments and blockchain and DeFi markets, announced today a partnership with Algorand. Algorand, the creator of the world’s first pure proof-of-stake foundational blockchain, is a leading blockchain technology company accelerating the convergence of decentralized and traditional finance. BridgeTower will use Algorand’s technology as the underlying blockchain solution to issuance of the BridgeTower Capital tokenized digital security. It will also use Algorand as a preferred blockchain for BridgeTower products and services. Beyond the elementary requirement of an open, public network, Algorand’s technology enables a set of high performing Layer-1 blockchains that provide security, scalability, complete transaction finality, built in privacy, Co-Chains, and advanced smart contracts. “Algorand was a clear choice given their technology, team and leadership position in the digital marketplace,” said