Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 321

Posts Tagged ‘manifacturing’

c-LEcta develops highly efficient manufacturing process for active cosmetic ingredient

Posted by fidest press agency su sabato, 9 marzo 2019

For the fermentative manufacturing process, c-LEcta’s scientists developed a new microorganism using targeted changes in the metabolic properties, which contributes to exceptionally high yields in the production of active ingredients.Dr. Andreas Buthe, Head of Innovation and Senior Business Development Manager at c-LEcta, played a key role in the development: “We are proud to have again been able to demonstrate the innovative power of our unique technology platform with this manufacturing process. Following the successful establishment of the process, we are now beginning to implement industrial scale-up and commercialization.”Due to the cost-intensive manufacturing process, the active ingredient has so far only been contained in expensive premium products. c-LEcta’s optimized bioprocess now makes it possible to use the active ingredient in cheaper cosmetics and to provide a wide range of products with versatile care properties.“With the development of this bioprocess, we have not only reached an important technical and scientific milestone. We are also providing the cosmetics industry with a more cost-effective source of supply, thereby contributing to a wider availability of the scientifically proven benefits of the active ingredient for consumers in everyday use,” explains Dr. Marc Struhalla, co-founder and CEO of c-LEcta. The development of c-LEcta’s own products, which can be marketed by c-LEcta directly to various customers worldwide, is part of the Leipzig-based company’s growth strategy. The second pillar are strategic, equal partnerships with established industrial companies in which c-LEcta makes targeted use of the potential of global megatrends. c-LEcta attributes an annual sales potential in the double-digit million-euro range to the marketing of the body care active ingredient in the medium term.

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Ensuring Access to Medicines for Patients: Pharmaceutical industry associations

Posted by fidest press agency su mercoledì, 21 gennaio 2015

BruxellesBrussels, AESGP, EFPIA, EGA, and PPTA are pleased to announce today’s release of the joint principles for “Communication of information on quality and manufacturing potential supply disruption”. This document forms part of the industry response to the EMA (European Medicines Agency) call for voluntary and proactive action, to provide European patients with continuous access to medicines.
There can be multiple causes to medicines shortages, including issues relating to quality and manufacturing. In cases where a disruption to the manufacturing process of a medicine arises, Marketing Authorisation Holders (MAHs) are obligated to timeously notify Competent Authorities (CAs). This document addresses such communications, and complements the output from the professional organisations ISPE & PDA on the prevention of such supply disruptions – see enclosed summary report.
This ‘Principles’ document introduces a harmonised approach to the communication of information by MAHs, meeting the complex and divergent data requirements across national CAs and EMA. This is expected to facilitate coordinated action between CAs; it will further enable CAs to gather standardised data for the identification and analysis of the causes, while considering mitigation strategies. This ‘Principles’ document constitutes a first and concrete step in the right direction and was warmly welcomed by the EMA and national CAs.AESGP, EFPIA, EGA, and PPTA believe that more can be achieved within the EMA initiative, particularly on reporting and notification mechanisms beyond manufacturers, which should form the next key milestone of the EMA initiative for 2015. This necessitates an integrated solution involving all stakeholders in the supply chain, illustrated in the recent report commissioned by DG Sanco1.The pharmaceutical industry is fully committed to working with these stakeholders, to mitigate factors that could contribute to supply disruptions, and to provide European patients with continuous access to the medicines they need.

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