With AST Academy fully launched, AST now provides training, services, and consulting for the full scope of commissioning, qualification, and validation to boost drug manufacturing start-up.
AST recently rolled out the dynamic expansion of its customer training and service offerings with the introduction of AST Academy. AST Academy offers comprehensive expertise and resources to get drug product manufacturing operations off the ground and streamlined to commercial realization. The program will equip drug manufacturers with the training, tools, and services needed to get AST equipment compliant and production-ready. Academy team members will provide cGMP guidance and resources to address risk analysis, aseptic program development, and CQV needs.
A pressing trend throughout the life sciences industry has been the need for holistic approaches to the full drug development lifecycle. Comprehensive planning for quality, compliance, and project ramp-up is needed more than ever as manufacturers look for streamlined paths to commercial cGMP production. Regulatory bodies have increasingly emphasized digitalization and advanced technologies, and have moved towards harmonious, clearer standards of quality and accelerated product approvals. The collective momentum has spotlighted both the need for scalable, quality-by-design solutions and the clear optimism across the industry towards new and innovative products.
A recent survey took the pulse of the industry, and many see a robust outlook for commercial manufacturing. Nearly 70 percent of stakeholders are expecting to see significant growth in GMP manufacturing or both GMP and R&D activities over the next 5 years in the US alone. Those expectations continue to grow as markets in Asia and Europe are considered. With an increasing emphasis on getting sterile medical products to market faster, manufacturers continue to evaluate their regulatory and GMP readiness. Entities like CDMOs are managing increasingly diverse product pipelines while expanding their scope of service and their focus on digital fluency and cGMP expertise. Biopharmaceutical startups and other small pharma companies continue to consider the challenges in navigating compliance while balancing manufacturing and product requirements. More than ever, aseptic processing solution providers are being looked to for not only standardized, proven technologies but also for full-service, turnkey offerings backed by exhaustive aftermarket and project ramp-up resources. AST Academy is designed to meet manufacturers wherever they may be along the road to operational start-up.
AST Chief Commercial Officer Charisse Curtis said of the service expansion, “AST’s customer-focused approach is built on anticipating needs within our industry and providing innovative, flexible, and forward-looking solutions. AST Academy gives us the opportunity to provide meaningful support and expertise for areas essential to our customers’ success, as they look to ensure product quality, compliance, and improve time to market. It’s an exciting next step in our commitment to being a full-service resource for pharmaceutical manufacturers.”
The program offers standalone training and services for the full scope of commissioning, qualification, and validation, including cGMP documentation, protocol generation, smoke studies, intervention planning, and aseptic process design for equipment and facilities. Customizable packages of services and training are also available, including the full-service accelerated ramp-up package, AST Launch.
AST Academy is led by industry veteran and aseptic processing SME Jason Rossi, Principal CQV Engineer. “This program addresses the most critical operational milestones in the lead-up to production and beyond,” Rossi commented. “From the facility to the fill line to the overarching QRM initiatives, there’s a pressing need for holistic approaches that consider the process and regulatory demands of sterile drug products throughout the entire product lifecycle. Our team is ready to get to work implementing these tools and strategies alongside our customers.”
AST Academy’s full catalogue of services and trainings can be viewed here: https://www.ast-inc.com/ast-academy/
Contact our team to learn how AST can assist in bridging the CQV process and ensure your facilities, processes, and personnel are cGMP-ready.
