Clinical Manufacturing

Clinical Manufacturing Capabilities for Your Clinical Supplies

At Halo Pharma, we can manufacture clinical supplies as small as 1 kg for oral solid dosage forms with a variety of unit operation equipment such as wet granulation, dry granulation, fluid bed technology (including the use of solvents), encapsulation, tablet compression and film coating.  We also can support stick pack filling (tablets and granules) for pediatric trials.  In addition, we can also support Liquid/Suspension clinical supplies as well as Powder in Bottle (PiB) dosage forms. Many of our clinical stage clients start in phase I and progress with us through phase III and into commercial as we have the ability to manufacture at the same site all the way through commercialization simplifying your regulatory path.  With 100+ clinical programs supported by Halo over the past 10 years, we have built a wealth of know-how in the area of clinical supplies.

Formulation Support

Our formulation scientists serve as a technical resource during every step of your clinical  development program.  This additional support ensures the proper scientific and technical decisions are made and you are getting the best advice possible.  From the bench to our pilot plant, the same formulator is assigned to your project to ensure continuity and the knowledge gained through development is maintained for registration and commercial launch.

Analytical Support

During clinical  development, Halo Pharma can support all of your analytical development programs.  Our analytical laboratories are equipped with both UPLC and HPLC’s as well as a full range of dissolution equipment and we provide analytical method validation services for phase I through through commercial.  Our stability services cover the entire range of ICH conditions as well as specialized conditions.

Packaging of Clinical Supplies

At both our facilities, we have packaging equipment to support your clinical studies.  We also have blistering equipment as well as bottling equipment depending on the clinical supply needs.