Case Studies
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New Molding Capability Enhances Product Quality And Shortens Supply Chain
How Pharma Tech Industries Proactively Turned A Challenge Into An Opportunity To Better Serve Customers.Released by: Pharma Tech Industries
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A Billion Reasons Why Innovation Works
How Pharma Tech Industries Turned A Complicated Effervescent Transfer Into A Manufacturing Milestone.Released by: Pharma Tech Industries
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A Defining Moment In Acquiring World-Class Expertise
How Pharma Tech Industries Turned Its First Major Technology Transfer Into A Blueprint For Success.Released by: Pharma Tech Industries
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Pharma Tech Makes Life-Saving Product Easier To Digest
How Pti Teamed With Daiichi Sankyo Pharmaceuticals To Reformulate Its Existing Cholesterol Product Into A New Dosage FormReleased by: Pharma Tech Industries
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Serialisation expertise: How Sharp responds to market demands
Our expertise and commitment to innovation ensured we met the market challenges for our client.Released by: Sharp
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Communicating Occupational Hazards Through Colour
This employee-driven initiative resulted in what is called the Occupational Exposure Band (OEB) system.Released by: Sharp
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Five Year Trouble Free Manufacturing for Large Pharma Company
Summary A large pharmaceutical contract manufacturing engagement demonstrating five years trouble free supply with OTIF (On-Time-In-Full) consistently >95%. Process and product improvement initiatives were also delivered, which enabled significan…Released by: Alkermes
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Product & Process Transfer of Low Solubility Compound with 6 year OTIF>95%
Summary The successful transfer of a low solubility compound into one of Alkermes manufacturing sites achieving as a result, an OTIF (On-Time-In-Full) consistently over 95%.…Released by: Alkermes
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APIs
Highly Potent Technical Transfer and Commercial Manufacturing
Alkermes’ successful approach to commercialscal final dosage manufacture of drug product containing highly potent API Project History • Donor site capacity issue where the company was seeking an outsourcing manufacturing partner for co…Released by: Alkermes
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Process Validation | Validation
Joint Risk Assessment During Technical Transfer
A framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with a technical transfer To help drive the tech transfer of partner products, Alkermes sought to develop a risk assessment f…Released by: Alkermes
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SoluPath™ Offers Efficiency in Multiple Ways
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…Released by: Patheon
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SoluPath™ Improves Bioavailability by 4x in Just Three Months
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.…Released by: Patheon
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Resolving Issues Before They Happen with Molecular Structure Analysis
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.…Released by: Patheon
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Stability Through Excipient Compatibility Testing
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.…Released by: Patheon
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Taking Formulations to the Next Level
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.…Released by: Patheon
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Fast Dispersible Tablets – A Royalty-Free Line Extension Solution
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.…Released by: Patheon
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Clinical Trial Materials | Validation
Method Development and Validation That Keeps Projects On Track
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…Released by: Patheon
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APIs
Formulation Development for Complex APIs and Dose Forms
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…Released by: Patheon
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Validation
Reliable Analytical Method Development and Validation
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…Released by: Patheon
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Exploring the Limits of Chemical Purity Analysis
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.…Released by: Patheon
