Syntegon announced the sale of its newly developed Versynta microBatch production cell to its first U.S. customer. Kindeva Drug Delivery will use Versynta microBatch to further expand its suite of aseptic fill-finish contract development and manufacturing (CDMO) capabilities meeting the latest global pharmaceutical regulations and trends. Kindeva is a leading global CDMO that develops and manufactures products across a range of routes of administration including injectable, pulmonary, nasal, transdermal, and intradermal delivery.
Robotic competence on the smallest scale
“Syntegon’s Versynta microBatch enables Kindeva to offer significant flexibility to our customers by rapidly adding clinical development and small-scale commercial GMP filling capacity, which complements our large-scale vial, syringe, and cartridge isolator filling lines. Syntegon’s technology expertise is unquestionable, but it is their ability to partner that has really made this an ideal collaboration for Kindeva,” said David Stevens, Kindeva Global Chief Commercial Officer. “Versynta microBatch provides agility, best-in-class automation, and sterility assurance that meets our patient safety and regulatory compliance objectives which we believe sets the standard for CDMOs.”
The fully automated production cell is specifically designed for very small batches of highly potent and often highly costly drugs, for instance in the field of cell and gene therapy, where maximum product yields are key. Versynta microBatch fills between 120 and 500 syringes, cartridges, and vials made of glass or plastic per hour with virtually no product loss. Fast batch-to-batch changeovers ensure that efficiency remains high without compromising on flexibility.
Prepared for regulatory challenges
As Kindeva serves a global client base, compliance with local regulations of its target markets is paramount. For Europe, this includes the new EU GMP Annex 1, which is setting new benchmarks in aseptic fill-finish operations. Syntegon developed Versynta microBatch with these requirements in mind: the gloveless isolator with integrated air treatment significantly reduces operator intervention and the risk of contamination. The 100 percent in-process control ensures high quality. Five integrated inline inspection systems provide special safety, while optional network cameras ensure continuous monitoring of production in the isolator via remote access.
“During my 35 years of working in the pharmaceutical packaging and processing business, it is rare to experience the partnership Syntegon and Kindeva enjoy. With our joint successes, their experience, and high level of technical capabilities, Kindeva is a perfect partner for our technology-leading Versynta microBatch,” said Kerry Fillmore, Managing Director of Syntegon Pharma Technology in North America.