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 BioSafety Cabinet

located in a Class B cleanroom, while the formulation of non-sterile products and placebo’s is

carried out in a Class A BioSafety 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 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.

 

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 are 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.

 

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.