Patheon > Knowledge Library > Case Studies

Wednesday, March 27, 2013

【事例紹介】　化学純度分析(HPLC—PDA)の限界検証
By wakako.kawada@patheon.com @ 4:11 AM :: 275 Views

【事例紹介】化学純度分析(HPLC—PDA)の限界検証 Link to Case Study

Wednesday, March 27, 2013

【事例紹介】　SoluPath™検討事例
By wakako.kawada@patheon.com @ 3:55 AM :: 180 Views

【事例紹介】 SoluPath™検討事例 Liink to Case Study

Monday, January 14, 2013

Urgent Technology Transfer Preserves Global Supply Case Study
By ann.roberson@patheon.com @ 1:10 PM :: 1263 Views

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

Wednesday, January 09, 2013

Expertise and Comprehensive Resources for High-Potency Drugs Case Study
By ann.roberson@patheon.com @ 1:06 PM :: 1192 Views :: 0 Comments ::

:: Formulation Development, Analytical Method Development & Validation, Late Development, Method Development & Validation, Highly Regulated Products, Controlled Substances, High Potency, Process Development, Quality by Design (QbD), Clinical Trial Material Manufacturing - LD, General Description of Section - Late Development, Process Development and QbD, Release & Stability Testing - LD

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.

Wednesday, January 09, 2013

Seamless Scale-Up of Lyophilized Vial Products Case Study
By ann.roberson@patheon.com @ 1:01 PM :: 860 Views

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.

Wednesday, January 09, 2013

Custom Solutions for Difficult to Manufacture Products Case Study
By ann.roberson@patheon.com @ 12:55 PM :: 757 Views

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.

Wednesday, January 09, 2013

Fast Dispersible Tablets – A Royalty-Free Line Extension Solution Case Study
By ann.roberson@patheon.com @ 12:50 PM :: 1281 Views :: 0 Comments ::

:: Late Development, Lifecycle Management Services, Solid, Specialized, Fast Dispersible Tablets, Products, Process Development, Clinical Trial Material Manufacturing - LD, Contract Manufacturing, General Description of Section - Commercial Supply, General Description of Section - Late Development, Pharmaceutical Development, Release & Stability Testing - LD, Controlled-Release Tablets

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.

Wednesday, January 09, 2013

Quick to Clinic™ – Release of Clinical Batches in Only Seven Weeks Case Study
By ann.roberson@patheon.com @ 12:43 PM :: 802 Views :: 0 Comments ::

:: Early Development, Formulation Development, Analytical Method Development & Validation, Clinical Trial Material Manufacturing - ED, Powder Filled Capsules, Specialized, Services, General Description of Section - Early Development, Pharmaceutical Development, Quick-to-Clinic

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.

Wednesday, January 09, 2013

SoluPath™ Offers Efficiency in Multiple Ways Case Study
By ann.roberson@patheon.com @ 12:22 PM :: 892 Views :: 0 Comments ::

:: Early Development, Chemical Purity Analysis, Physiochemical Properties, Solid Form Definition & Analysis, Molecular Structure Analysis, Excipient Capability Testing, Pre formulation, Formulation Development, Analytical Method Development & Validation, Services, SoluPath®, General Description of Section - Early Development, Pharmaceutical Development, Quick-to-Clinic

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.

Wednesday, January 09, 2013

SoluPath™ Improves Bioavailability by 4x In Just Three Months Case Study
By ann.roberson@patheon.com @ 10:38 AM :: 841 Views

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.

Wednesday, January 09, 2013

Rapid Response to a U.S. FDA Emergency Request Case Study
By ann.roberson@patheon.com @ 10:16 AM :: 740 Views

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.

Wednesday, January 09, 2013

Large Tech Transfer Earns European Outsourcing Award Case Study
By ann.roberson@patheon.com @ 10:06 AM :: 596 Views

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.

Wednesday, January 09, 2013

Expanding Capacity with Flexible Packaging Services Case Study
By ann.roberson@patheon.com @ 9:48 AM :: 642 Views

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.

Wednesday, January 09, 2013

Continued Success with Lifecycle Management Services Case Study
By ann.roberson@patheon.com @ 9:38 AM :: 1005 Views

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.

Wednesday, January 09, 2013

Method Development and Validation That Keeps Projects On Track Case Study
By ann.roberson@patheon.com @ 9:30 AM :: 700 Views

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.

Wednesday, January 09, 2013

Taking Formulations to the Next Level Case Study
By ann.roberson@patheon.com @ 9:25 AM :: 762 Views

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.

Wednesday, January 09, 2013

Reliable Analytical Method Development and Validation Case Study
By ann.roberson@patheon.com @ 9:20 AM :: 657 Views

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.

Wednesday, January 09, 2013

Formulation Development for Complex APIs and Dose Forms Case Study
By ann.roberson@patheon.com @ 9:15 AM :: 613 Views

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.

Wednesday, January 09, 2013

Stability Through Excipient Compatibility Testing Case Study
By ann.roberson@patheon.com @ 9:09 AM :: 695 Views

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.

Wednesday, January 09, 2013

Resolving Issues Before They Happen With Molecular Structure Analysis Case Study
By ann.roberson@patheon.com @ 8:57 AM :: 611 Views

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.

Wednesday, January 09, 2013

Exploring the Limits of Chemical Purity Analysis Case Study
By ann.roberson@patheon.com @ 8:15 AM :: 630 Views

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.

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