The Versynta microBatch from Syntegon was sold to a customer in the USA for the first time. The production cell will be used by Kindeya Drug Delivery to expand its aseptic contract development and production capacities. Syntegon's solution complies with current global regulations.
„With the Versynta microBatch from Syntegon, we can offer our customers maximum flexibility. They quickly receive additional, GMP-compliant filling capacities for clinical development and for small-volume commercial applications, which complement our large isolator filling lines for vials, syringes and cartridges. In addition to Syntegon's technological expertise, the partnership was the decisive factor for the co-operation. With the Versynta microBatch, we get agility, world-class automation and sterility that fulfils our patient safety and regulatory compliance goals and, in our opinion, sets new standards for CDMOs.“
David Stevens, Kindeva Global Chief Commercial Officer
The fully automated production cell is specially designed for highly effective and often very expensive drugs in very small batches, such as those used in cell and gene therapy. Maximising product yield is crucial in this area. The Versynta microBatch production cell fills between 120 and 500 syringes, cartridges and vials made of glass or plastic per hour with virtually no product loss. Fast batch changes ensure high efficiency without compromising flexibility.
As Kindeva serves a global customer base, compliance with the respective regulations of the target markets is of the utmost importance to the company. For Europe, this applies in particular to the new EU GMP Annex 1, which places high demands on aseptic filling and processing procedures. Syntegon has developed its Versynta microBatch with these requirements in mind right from the start: The gloveless isolator with integrated air treatment significantly reduces operator intervention and therefore the risk of contamination. High quality is ensured by the 100 per cent in-process control (IPK). Five integrated inline inspection systems provide special security, while optional network cameras ensure the Continuous monitoring of production in the isolator via remote access guarantee.
„During my 35 years in the pharmaceutical packaging and process industry, I have rarely experienced a collaboration like the one between Syntegon and Kindeva. Our joint successes and Kindeva's experience and extensive technological expertise make the company the ideal partner for our Versynta microBatch.“
Kerry Fillmore, Managing Director of Syntegon Pharma Technology in North America
The Versynta microBatch production cell also takes account of the trend towards ready-to-use (RTU) containers, which are very popular for both small batches and high-output lines. At Achema, visitors can get an idea of Syntegon's comprehensive technological and pharmaceutical expertise in the „RTU Open Space“ at its stand: In addition to virtual insights into the Versynta portfolio for small and very small batches, Syntegon's experts will offer advice on all aspects of ready-to-use containers - from Annex 1 compliance and filling with 100 per cent IPC to the use of gloveless barrier technologies.
Source: Syntegon
