Solutions for Injection
PDC is experienced in the formulation, development, and manufacture of sterile solutions by aseptic processing, terminal steam sterilization, and coordination of terminal gamma irradiation sterilization. Batch sizes range from 100 mL to 250 L with fills varying from ½ ml to 100 ml in vials or ampoules. PDC will formulate the product to be iso-osmotic and in an appropriate pH range to be stable and compatible with the body. We have expertise with non-aqueous liquid drugs and formulation capabilities with co-solvents for insoluble drugs. Also, for stability concerns the headspace can be over-layed with nitrogen or argon. The ingredients are screened for compatibility, the components and filters are evaluated, and the product is filled into a suitable container/closure system. PDC will develop all microbiological methods to support the product, i.e., sterility, LAL, and particulate testing methods and will release the product based on these and appropriate analytical methods transferred in or developed and validated in-house. We support the product throughout its shelf life with ICH stability and special stability conditions, if needed. To facilitate the product's use, PDC will evaluate the product's use with large volume parenterals for dilution potential.
PDC has developed and manufactured a variety of products for lyophilization, including peptides, proteins, DNA, and some novel formulations for further processing as powders. Unit doses have been produced as low as 50 mcg per vial. We will develop the formula with appropriate evaluation of cryoprotectents, pH, osmotic modifiers, and adjuvants. Generally, a cycle will be developed and optimized suitable to early Phase I/II use with attention focused on cycle parameters, cake evaluation, Karl Fisher moisture, content uniformity, and stability. The vials are sealed in the sterile chamber with options to retain some vacuum or overlay with nitrogen or argon. Current batch sizes range up to 1200 units for 10 mL vials and will soon be expanding to 6500. PDC will develop the microbiological methods for sterility and LAL as well as analytical methods to support release and stability. Special storage is available at 5ºC and -20ºC and special cryo-labels can be applied.
PDC has sterile fill capabilities for small volume powders to support Phase I and Phase II clinical development. Under special conditions we have depyrogenated powders at low temperature and under complete vacuum to avoid stability issues with temperature and oxygen sensitive drugs. Hand weighing of batches under aseptic conditions has been accomplished as low as 20 mg per vial with 100% accountability. Also, batches have been produced using a semi-automatic machine to give higher rates of up to 1000 vials per batch. To support these products microbiological methods, including sterility and LAL can be developed as well as the analytical methods and stability. PDC has also produced diluent for powders, both in vials and in ampoules.
Pharmaceutical Development Center (PDC), 4221 Faber Place Drive, North Charleston, SC 29405-8510. Tel: 843-746-2500; Fax: 843-746-2550.