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Research & Development

API & Drug Product Development >> API Development >> Scale-Up Capabilities

The mission of PMC ISOCHEM's R&D consists of chemical, process & analytical R&D, up-scaling & production improvement. Thanks to a broad technology platform & lifecycle management experience, PMC ISOCHEM's R&D team takes your product to the next level.

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Small-Scale Manufacturing Platform

API & Drug Product Development >> API Development >> Scale-Up Capabilities

Strengths of AMRI's small-scale manufacturing platform include clinical API manufacturing and clinical drug product manufacturing up to 10kg, including oral drug products and sterile fill and finish.

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Lab, Kilo & Pilot Scale Manufacturing For Clinical Studies

API & Drug Product Development >> API Development >> Scale-Up Capabilities

Our cGMP small molecule API custom manufacturing capabilities include Lab, kilo and pilot scale manufacturing for pre-clinical studies and all phases of clinical trials – supplying mg to kilogram quantities.

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Custom Synthesis for the Supply of Few Grams to Pilot Batches

API & Drug Product Development >> API Development >> Scale-Up Capabilities

Design of a novel synthetic pathway accompanied by supply of a few grams, provision of pilot batches following development of the industrial procedure and GMP production of several tons of product along with regulatory file drafting.

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Scale-Up Capabilities

API & Drug Product Development >> API Development >> Scale-Up Capabilities

That’s why we’ve built a seamless development solution that enables you to begin your active pharmaceutical ingredient development in our Devens R&D lab and then migrate it directly into our cGMP Newburyport API plant, where we offer up to 20,000 gallons of manufacturing capacity.

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Lab-Scale And/Or Pilot Scale Experimentation

API & Drug Product Development >> API Development >> Scale-Up Capabilities

Capua BioServices has extensive experience in working with customers on projects from all over the world. We offer services like Lab-scale and/or pilot scale experimentation.

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Laboratory Batch Scale to Pilot & Full Production Scale

API & Drug Product Development >> API Development >> Scale-Up Capabilities

Biovian provides linear scale-up from laboratory to full GMP production scale aiming for high quality and cost efficiency.

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Pilot & Commercial Quantities of APIs

API & Drug Product Development >> API Development >> Scale-Up Capabilities

Pharmathen’s R&D activities have been vertically intergraded including Research and Development of Active Pharmaceutical Ingredients (APIs). Both labs are outfitted with the most technologically advanced and state of the art instrumentation and equipment.

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