Axcellerate Pharma’s Contract research division helps you accelerate your timelines, reduce overall costs and facilitate your milestones. We can take you all the way from preliminary drug discovery, process development into scale-up and manufacturing. Our accomplished chemists have varied experience to create your molecules in our custom synthesis laboratories. We can additionally take the molecules through a rigorous optimization and scale-up procedure to create additional value for the client. The contract research services are supported by fully equipped analytical and cGMP synthesis.
Axcellerate Pharma operates as a cGMP API manufacturing facility for clinical trial material and can take the client molecule from all stages of development into cGMP clinical material production. Our synthesis division is completely qualified by our extensive quality control department ensuring complete cGMP compliance in all aspects.
cGMP Aseptic Filling
Axcellerate Pharma offers a cGMP Aseptic Filling facility with sterile areas ranging from ISO Class 8 through ISO Class 5 to fulfill all your integrated operational needs. All the areas in the facility are routinely monitored for viable and non-viable particulates on surfaces as well as air-borne and supported by our Analytical and Quality Assurance Department.
Axcellerate Pharma offers an extensive formulation development platform. Our goal is to develop and optimize dosage form delivery systems for our clients. Axcellerate Pharma has extensive expertise in the following: Lisposomal Formulation PEGylation Microsphere encapsulation
Axcellerate Pharma offers both FTE (Full time Employee) and FFS (Fee for Service) models for development as well as manufacturing. A client requiring “feet on the ground” can avail of the service in Axcellerate Pharma, whereby we offer the employees that are required along with the use of the facility not only in the development segment, but also in the manufacturing segment. Axcellerate Pharma can also work like a regular CRO/CDMO providing a fee for service model.
Axcellerate Pharma specializes in development of analytical methods for drug substance and drug product. We also provide method validation services including linearity, precision etc. to ensure complete confidence in the methods developed.