Patheon is a global provider of development and commercial manufacturing services for solid and sterile prescription drugs, offering a wide variety of services and products. SEE AND Read More »

Exploring the Limits of Chemical Purity Analysis Case Study

1/9/2013
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.

Reliable Analytical Method Development and Validation Case Study

1/9/2013
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 recovery.

Stability Through Excipient Compatibility Testing Case Study

1/9/2013
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.

Resolving Issues Before They Happen With Molecular Structure Analysis Case Study

1/9/2013
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.

SoluPath™ Improves Bioavailability by 4x In Just Three Months Case Study

1/9/2013
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.

Quick to Clinic™ – Release of Clinical Batches in Only Seven Weeks Case Study

1/9/2013
Quick to Clinic™ is a complete package of services designed to accelerate a project to Phase I trials. The clinical batches for the company in this case study were released in just seven weeks – including a 4-week stability test.

SoluPath™ Offers Efficiency in Multiple Ways Case Study

1/9/2013
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 maximizes speed, efficiency and value.

Formulation Development for Complex APIs and Dose Forms Case Study

1/9/2013
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 storage.

Method Development and Validation That Keeps Projects On Track Case Study

1/9/2013
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.

Fast Dispersible Tablets – A Royalty-Free Line Extension Solution Case Study

1/9/2013
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.

Taking Formulations to the Next Level Case Study

1/9/2013
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.

Continued Success with Lifecycle Management Services Case Study

1/9/2013
Patients didn’t like the extremely bitter flavor of a customer’s tablet. Patheon created and tested a custom taste masking solution to improve patient compliance, and open the door to exclusivity in the pediatric market.

Expanding Capacity with Flexible Packaging Services Case Study

1/9/2013
A company was limited by packaging capacity at their own facility. Patheon adapted a packaging line to meet the specific demands of their project, saving the customer the capital expense of upgrading their own facility.

Large Tech Transfer Earns European Outsourcing Award Case Study

1/9/2013
Patheon transferred 33 solid dose products, 8 formulations, 11 packaging formats and 85 regulatory variations from an outdated facility in less than three years, and without interruption of supply.

Rapid Response to a U.S. FDA Emergency Request Case Study

1/9/2013
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.

Custom Solutions for Difficult to Manufacture Products Case Study

1/9/2013
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 fold.

Seamless Scale-Up of Lyophilized Vial Products Case Study

1/9/2013
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.

Expertise and Comprehensive Resources for High-Potency Drugs Case Study

1/9/2013
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.

Urgent Technology Transfer Preserves Global Supply Case Study

1/14/2013
Patheon’s exceptionally efficient approach to technology transfers ensured an uninterrupted global supply for a company having critical quality compliance issues with another CMO.

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