The accreditors of this session require that you periodically check in to verify that you are still attentive.
Please click the button below to indicate that you are.
The 2025 ISPE Aseptic Conference serves as a platform where the newest developments in aseptic processing, robotics, and automation are explored in depth. It addresses the complex challenges associated with sterilizing small-batch aseptic products and accelerating their time-to-market…
Explore the future of aseptic manufacturing firsthand with a virtual tour of Kindeva's state-of-the-art Bridgeton, Missouri facility. Recently completed in 2024, this cutting-edge sterile fill-finish site spans over 155,000 sq. ft. and features dedicated aseptic operations, labs, formulation suites, and 11,000 sq. ft. of advanced fill suites. Attendees will navigate through the facility, gaining insights into the strategic decisions that enabled its design, construction, and rapid operationalization within just one year.
Highlights of the new Annex 1-compliant facility include automated isolated fillers for NTT and PUPSIT testing, electronic batch records, single-use systems, and versatile capabilities for syringes, cartridges, and vials. The session will also showcase the facility's utilization of virtual reality modeling for design, training, and marketing purposes, setting a new standard for efficient, high-tech aseptic facility construction.
This virtual tour and case study will offer valuable insights into the collaborative efforts and strategic planning that drove the success of the Kindeva project emphasizing automation, regulatory compliance, and operational excellence amidst evolving market demands.
New modalities present unique challenges to the manufacturing of medicinal products. Radiopharmaceuticals and antibody-drug-conjugates (ADCs) need special containment, while advanced therapeutical medicinal products (ATMPs) are often patient specific…
In the evolving pharmaceutical landscape, Contract Development and Manufacturing Organizations (CDMOs) play a pivotal role in responding to dynamic market demands…
The revision and approval of EU Annex 1 have captured key aseptic processing expectations by regulators for the industry and have challenged the industry to continue to advance technologies to improve the aseptic processing of sterile drug products…