A&C is a service driven organization finding unique solutions to our customers’ GMP challenges. We provide customized GMP services for the pharmaceutical and biopharmaceutical industries, aimed at solving our customers’ technical, production, stability and regulatory issues. We offer highly personalized GMP services for all of our products (excipients, buffers, process solutions and APIs), including custom formulations of products and tailored solutions for GMP packaging.
GMP CUSTOM INGREDIENT DEVELOPMENT
A&C can fulfill the need for custom or novel raw materials through a practical process development approach in all three of our GMP manufacturing facilities. Should a customer require a specific excipient or other raw material to be manufactured within a fully compliant GMP process, A&C offers this service with transparency and will provide full supporting documentation.
GMP CUSTOM MANUFACTURING
Once the process developed by A&C is completed and validated, the product is manufactured, packaged and released under full GMP compliance. Custom manufacturing of excipients, buffers and process solutions for our global client base has allowed A&C to rapidly resolve our customers’ issues with commercial finished drug manufacturing. With over five decades of experience in custom manufacturing of excipients, A&C has the necessary expertise to solve our clients’ GMP challenges.
GMP CUSTOM PACKAGING
One of A&C’s GMP services is custom GMP packaging. We offer custom GMP packaging formats that meet FDA and EU packaging requirements. Our custom GMP packaging can be tailored to customers’ batch-specific container sizes for both liquids and powder raw materials. Volumes and testing are designed to meet customers’ specific requirements. Product packaging is completed in an ISO Class 8 clean room environment. Packaging formats range from 100 mL to 1,000 L, and include:
- Glass bottles (clear & amber)
- Plastic drums HDPE (various formats)
- Stainless steel drums (various formats)
- Phenolic resin lined steel drums
- Single use bio process bags
PARTNER SERVICE ORGANIZATION
A&C has developed the Partner Service Organization (PSO) approach which enables us to be a strong strategic partner for our pharmaceutical and biopharmaceutical customers. Understanding our partners’ needs from the start allows us to find unique and tailored solutions to our clients’ specific issues. We offer highly-personalized GMP services to solve our customers’ GMP challenges through an innovative approach.