Small Scale Manufacturing

Manufacturing

The aseptic production of clinical trial material (CTM) must be carried out under Good Manufacturing Practice (GMP) regulations. This implies the use of batch manufacturing records, validated manufacturing, analytical and cleaning processes, and qualified staff.

PROXY's GMP production activities are focused on manual filling, finishing and labeling of small CTM batches. Sterile products and placebo’s are manufactured in a Class A Downflow Cabinet located in a Class B cleanroom, while the formulation of non-sterile products and placebo’s is carried out in a Class A Downflow Cabinet located in a Class C cleanroom. PROXY's production environment is the basis for a consistent product quality and facilitates the transfer to larger scale contract manufacturers, with whom we often collaborate.

Labeling

Labeling of (bio)pharmaceuticals is a very critical process, requiring strict control and procedures. After approval of master labels, primary and secondary packaging components are labeled in compliance with Annex 13 of the GMP guidelines.

Batch release

PROXY can release production batches in all stages of the drug development trajectory. If necessary, PROXY can (re)develop and (re)validate analytical methods, for instance when production batches are upscaled to other contract manufacturers. The major advantage of outsourcing these activities to PROXY is that consistency is maintained in analytical methodology and results and that costs for analytical transfers and validations are significantly reduced.

Several Qualified Persons are available for the certification and release of production batches.

Storage and distribution

Biotechnology based companies are often restricted in the logistics of Clinical Trial Medication, because they are not allowed to store their products in house. PROXY offers storage and distribution in its facilities, therewith assuring inventory control, cold chain management and reduction of stock losses. Retain and Reference samples can be stored long-term in dedicated storage areas.