GMP Manufacturing Services

After product development activities are completed, technology is transferred seamlessly to a partner CMO through the active participation and supervision of ExxPharma via a manufacturing services agreement. ExxPharma has overall technical responsibility while the partner CMO is responsible for all GMP and quality matters. 

To ensure seamless technology transfer, the critical piece of equipment that is employed for clinical trial material (CTM) and eventually commercial manufacturing is kept the same as that used during formulation development. Similarly, the key personnel who develop formulation/process and analytical methods work closely with the CMO staff to carry out tech transfer activities and provide the necessary technical support during CTM manufacturing. Critical process parameters which are identified and characterized during formulation development are utilized without any changes during CTM manufacturing. As a result, product characteristics of in-process materials and dosage forms that are determined during formulation development remain unchanged during manufacturing, and, in turn, allow generation of sufficient stability data that help establish specs at the time of registration and commercialization of a fast track product, as well as accelerate development time and time-to-market.

Product characteristics that determine the end product include:

  • Content uniformity

  • Particle size distribution

  • Granule flow characteristics

  • Compressibility

  • Disintegration

  • Dissolution

  • Assay

  • Impurities

  • Physical stability

  • Chemical stability

  • Dissolution stability

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