HUNT VALLEY, MD– 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.
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
Pii is a privately held CDMO providing dosage form, process development and regulatory affairs services, as well as, cGMP manufacturing services to the global pharmaceutical industry. Headquartered in Hunt Valley, Maryland USA, Pii's services include pre‐formulation development, clinical and commercial cGMP manufacturing of parenterals in vial, syringe and cartridge presentations (including aseptic filling, terminal sterilization, and lyophilisation), liquids, suspensions, oral solids (including soft gels, tablets and capsules, with modified and extended release), primary and secondary packaging. In addition, the Pii offers containment suites to handle hormones, potent drugs and Schedules I‐V controlled substances