Pharmaceutics International, Inc. (Pii), a pharmaceutical contract development and manufacturing organization (CDMO), announces the expansion of its aseptic filling capacity and capabilities with the addition of a new, fully robotic filling line.
Pii has installed a GENiSYS® R filling machine from Automated Systems of Tacoma, LLC (AST), which processes pre-sterilized, ready-to-fill vials, syringes, and cartridges on a single machine specifically designed for small to medium scale aseptic manufacturing under cGMP. Integration of proven isolator-barrier and automated technologies provides a balance of flexibility and advanced system features, enabling processing of aseptic, toxic, and cytotoxic drug products.
Samuel Chia, Director of Aseptic Manufacturing, said, “This automated solution enhances system productivity and controls contamination risk by minimizing operator intervention to the greatest extent possible, while providing unrivaled flexibility for aseptic filling of medium-sized clinical and commercial batches.”
Automated bag and tub opening, statistical and 100% in-process fill weight verification, and vial capping completely automate the aseptic fill-finish process. Operations downstream can include lyophilizer loading and unloading and vial capping, depending on product and application requirements. Dr. Tom Ingallinera, Pii’s VP of Technical Support, advises that companies can benefit from the scalability of processes developed for the GENiSYS machine. “As customer’s products progress through the clinic, the aseptic filling process can be scaled to larger filling lines with minimal tech transfer,” he said.
The new line, installed with assistance from Automated Systems of Tacoma (AST), will be fully qualified to support vial and syringe operations by the end of Q1 2020, just one year after the initial purchase order was placed. Multiple programs in early to late-stage development have already been identified as candidates for transition to the new line. “The new innovative aseptic filling machine will enable Pii to continue delivering aseptic products on very aggressive timelines,” added Dr. Kurt Nielsen, Pii’s President and CEO.
Hank Nowak, Pii’s Vice President of Business Development, said, “With our Pharmaceutics Know-How and these expanded filling capabilities, Pii is positioned to deliver high quality and timely aseptic drug product for clinical and commercial needs. We look forward to working with existing and new partners on projects with batch sizes ranging from 1 L to 1,000 L.-Bio Space