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Last Updated Monday, May 25 2015

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Case Studies

May 8, 2015
SoluPath™ employs parallel screening of multiple solubility and bioavailability enhancing technologies for a fixed price. That alone adds speed in the race to First In Man trials. But it’s the way Patheon delivers this service that maximi…  Read More »
May 8, 2015
A small biotech company was developing a compound with poor solubility and bioavailability. Patheon’s SoluPath™ parallel screening service quickly and cost-effectively determined the best formulation to overcome these issues.…  Read More »
May 8, 2015
A new degradation product was observed in accelerated stability chromatograms for a new formulation. A tentative structural assignment was made by the customer's consultant but needed to be verified.…  Read More »
May 8, 2015
The chemical structure of a customer’s new molecule indicated potential for oxidative degradation and hydrolysis. Through binary excipient compatibility testing, Patheon was able to focus efforts on a formulation with maximum stability.…  Read More »
May 8, 2015
Patheon transferred a customer’s manufacturing process and delivered an improved formulation with better stability, scalability and manufacturability. We also prepared documentation for a robust CMC package for their NDA submission.…  Read More »
May 8, 2015
Patheon had developed a globally marketed coated tablet product for a medium-sized pharmaceutical company. To help them capitalize opportunities in the pediatric market, we developed a fast dispersible tablet line extension.…  Read More »
May 8, 2015
Our work for a customer needing clinical trial materials revealed that their transferred validation of HPLC methods was insufficient and poorly reproducible. Patheon resolved the issue averting potential delays to the project’s overall timeline…  Read More »
May 8, 2015
A large pharmaceutical company wanted to develop a bilayer tablet, each layer having different release profiles. One of the layers was low dose and moisture sensitive. There were also layer lamination issues during formulation development and in stor…  Read More »
May 8, 2015
A medium-size company needed to develop and validate a method for quantification of several potential genotoxic impurities in their drug substance. Their procedure, which included a derivatization step prior to analysis, suffered from variable recove…  Read More »
May 8, 2015
Patheon conducted a study to challenge the claim that a PDA detector has the capability of detecting co-eluting components in HPLC peaks since this is based on UV spectroscopy, which is relatively nonspecific.…  Read More »
May 8, 2015
With an expert team and fully integrated specialized scientific resources already in place, Patheon was able to take this high-potency small-molecule drug candidate from preclinical development all the way to commercial launch in less than five years…  Read More »
May 8, 2015
Patheon’s exceptionally efficient approach to technology transfers ensured an uninterrupted global supply for a company having critical quality compliance issues with another CMO.…  Read More »
May 8, 2015
Patheon’s expertise in lyophilization is clear to see in our scale up three different products from our PDS lab unit to our GMP 7m² system. Batch-to-batch, consistency of all key analytical properties was excellent for all three products.…  Read More »
May 8, 2015
A pharmaceutical company came to Patheon with a suspension formulation that’s high viscosity curtailed production speeds. We reengineered our manufacturing equipment to work efficiently with this specific product to increased throughput by four…  Read More »
May 8, 2015
A new customer had received an emergency use authorization from the U.S. FDA. The demand was large, and speed to production was critical. Patheon provided the readily available capacity and expertise to help the company promptly answer the call.…  Read More »



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