Manufacturing Engineering

Manufacturing Engineering and Process Optimization for a Biological Product
A Client was producing a biological drug from natural sources at laboratory scale, however, progress in pre-Clinical development demanded more drug material. The Client engaged Pharma Technology Resources to develop a commercially scalable process, which could supply its pre-Clinical and Clinical Programs. Pharma Technology Resources defined a strategy for compliance with cGMP at the appropriate point in the process, dividing the process into a company-operated front-end and an outsourced purification conducted under cGMP.

Pharma Technology Resources scaled up and engineered the front-end process, and specified and requisitioned equipment. PTR supervised equipment installation, commissioned the equipment, prepared operating procedures and trained personnel. Concurrently, PTR directed and managed the efforts of a Contract Process Development Laboratory to develop a purification process. At the conclusion of the process development program, required quantities of biological drug suitable for use in the Client’s Phase I Clinical Trial was produced under cGMP.

Packaging Line Integration
A Pharmaceutical Manufacturing Organization required a new packaging line for production of its potent peptide drug product solution. Pharma Technology Resources personnel served as engineering and project management resources for this complex project. PTR personnel addressed challenging safety issues, developed engineering specifications, and designed layouts for the equipment and facility. PTR personnel sourced the equipment, and managed facility construction, followed by equipment integration, testing and commissioning. Company personnel were trained in the operation of the equipment and PTR personnel collaborated on validation of equipment. The Organization was able to reliably produce its high-value product while meeting its requirements for operator safety.