IMPAX will extend and enhance our spectroscopy platform to specifically suit the needs of the pharmaceutical industry. A range of other applications that require deeper knowledge of manufacturing process controls and parameters will also be addressable, leading to improved output quality and consistency. Increased use of continuous manufacturing (CM) methods has set the spotlight on the lack of suitable and reliable ways to directly monitor process outputs in a way that can quickly and reliably detect deviations. ColVisTec has, for a number of years, supplied in-line UV-VIS spectroscopy systems that are specially designed for demanding manufacturing processes. Through IMPAX, we now build on this knowledge to extend this technology portfolio further. Our new instruments will include bespoke software and other supporting features that are necessary to meet the special demands of the pharmaceutical industry. IMPAX is supported by the Horizon 2020 SME Instrument programme of the European Union. Extruder based production is currently one of the most widely used CM techniques within plastics manufacturing and it is extensively applied in the food processing industry. Extruder based production is now beginning to be applied in pharmaceutical manufacturing for a wide variety of dosage forms and formulations, including: granules, pellets, tablets, capsules, implants, transdermal systems and ophthalmic inserts. Active pharmaceutical ingredients (APIs) are embedded within a carrier, containing meltable materials and additional (inactive) excipients. The pharmaceutical industry is facing the ongoing challenge of maximising bioavailability for an increasing number of poorly-soluble drug compounds. CM extruder processes such as Hot Melt Extrusion (HME)
On 10-11 October 2016 the European Commission's held the SME Instrument Innovators' Summit 2016 in Brussels. The event gathered participants from more than 30 countries with the aim of bringing together innovative business representatives who have received grants under the SME Instrument, in order to share their experiences, present ideas and to find new partners and investors from all over the world. In total there were over 400 participants and the program was appreciated by participants. The event was regarded as a great success by many of the companies present. IMPAX/ColVisTec also attended the summit and brought back several valuable contacts and insights.
De Montfort University, Leicester School of Pharmacy and ColVisTec AG are pleased to announce that the University has acquired a ColVisTec system for UV-VIS in-line spectroscopy measurement for use in their pharmaceutical pilot plant. Dr Walkiria Schlindwein said that the added ability to measure numerous aspects of the manufacturing process "in-line", will be a fundamental part of next-generation pharmaceutical manufacturing methods. She looks forward to experimenting with the novel measurement technologies developed at ColVisTec through the IMPAX program. In the words of the FDA; such Process Analytical Technologies (PAT), when used within a continuous manufacturing system, can provide an effective and efficient means for acquiring information to facilitate process understanding, continuous improvement and the development of risk-mitigation strategies. (mehr …)