Facilities & Manufacturing Information
The Plough Center contains a 1400 sq. ft. GMP-compliant core processing facility along with 6000 sq. ft. of research and training labs designed for the development, preparation, production and testing of small volume parenterals (SVPs). The core of the aseptic area has an ISO 8 area for compounding and an ISO 7 area with ISO 5 hoods for aseptic fill-finish operations. Major manufacturing equipment include autoclave, hot-air oven, stability chambers, lyophilizer, isolator, Metromatic container washer, Cozzoli table-top filler, Millipore ELIX100 water system, Cozzoli ampoule sealer and pneumatic vial crimpers. Key instruments for analytical services include HPLCs, UV-VIS, MS, DSC, TGA and Karl-fisher. Additionally, environmental monitoring is conducted using BioVigilant© IMD-A® system, Biotest® RCS sampler, MilliFlex® and Millipore Air-T® among others.
The facility and its associated laboratories provide the following services:
- pre-formulation studies,
- formulation development,
- manufacturing of liquid and lyophilized drug products for clinical investigation,
- manufacturing drug products for pre-clinical animal studies,
- development and manufacturing of complex drug delivery systems such as nanoparticulate drug delivery systems,
- manufacturing of drug products containing cytotoxic, potent and controlled substances,
- sterility testing,
- development of stability indicating assays,
- design and execution of real-time stability studies,
- development of lyophilization cycles,
- aseptic processing of radiolabeled products for ADME studies and clinical investigations,
- scale-up and technology transfer services.
The Plough Center specializes in the development and manufacturing of difficult to manufacture products such as cytotoxic drugs, drug molecules with poor water solubility and complex drug delivery systems. Ampoules, vials pre-filled syringes and lyophilized small and large molecules are a few of the products that the Plough Center can manufacture.
Examples of manufacturing projects include:
- multiple batches of sterile liposomal anti-neoplastic drugs,
- manufacturing of sterile nanoparticulate inhalation drug products,
- preparation and manufacturing of radiolabeled lyophilized product in double-stoppered syringes,
- several sterile radiolabeled lyophilized products for ADME studies,
- multiple batches of sterile injectable products including placebo.