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. Read More »
The event brings together an international mix of motivated buyers, manufacturers, distributors and sellers of high value chemistry for 4 days of sourcing, education & networking.
Visit us at booth # 1010
Dr. Kevin Kane will be presenting on the topic of late stageAPI development.
Meet with us at the DCAT Week. This is one of the largest gatherings in the world
for the pharmaceutical and related industries.
Join us at Booth 1438 March 18-20, 2014 in New York City for the leading annual gathering of pharmaceutical and biopharmaceutical manufacturing professionals.
Join us to witness and share your experiences with the world leaders from pharmaceutical and biopharmaceutical research rendering their expertise in pre-formulation, formulation and physiological approaches associated with pharmaceutical moieties.
Dr. Jason Vaughn, Director, Formulation and Process Development as he presents on preformulation considerations for solid and semisolid dosage forms.
A well-designed Quality by Design (QbD) approach to drug development and manufacturing can substantially minimize development and scale-up challenges and increase the reliability of the manufacturing process. While a wealth of information exists on the theory behind QbD, there is no “one size fits all” application of it. For a project to reap the added benefits of quality and robustness resulting from QbD, it is critical to understand how to use some of the QbD tools to identify and control the factors contributing to product variability. For example, reduced product variability from QbD can lead to cost savings as a result of decreased batch failure during routine manufacture.
During this 60-minute webcast, two industry experts will share case studies and their experience with QbD and offer insight into how the practical application of QbD contributed to the success of their projects — steps that can be universally applied to your projects.
Don Barbieri, associate director of formulation and process development, Patheon, will present case studies demonstrating different aspects of the QbD approach, including identifying CQAs (critical quality attributes) and CPPs (critical processing parameters) as well as risk assessment determination, risk mitigation, DoE, and more.
David Smith, pharmaceutical specialist, formulation and process development, Patheon, will present a case study where the pragmatic application of QbD enabled a successful tech transfer of a film-coated tablet from Phase III to commercial scale.
Trends in Safe Handling of Potent Compounds in Pharmaceutical Manufacturing Processes
In the pharmaceutical industry, an increasing number of new drug candidates are considered “highly potent”, which can have significant impact on how they can be safely handled in drug product development and manufacturing.This webcast explores what the term “highly potent” means and discusses what is required to manufacture these drugs from an equipment containment perspective.The main focus will be on the safe handling of these drugs (e.g. safety of equipment operators). However, these principles also apply to meeting Good Manufacturing Practices (GMP) requirements for minimizing cross-contaminationto other drugs manufactured in the same facility. The use of control banding, a procedure for assigning an active pharmaceutical ingredient to a potent or non-potenthazard category corresponding to an airborne concentration range, will also be discussed. Two case studies that are designed to highlight the key take home messages of this session will be presented.
Marvin Faber, PhD, DOHS, CRSP - Sr. Director, Global Head EH&S at Patheon: “Overview of Safe Potent Compound Handling”
Giuseppe Galati, PhD - Manager, Toxicology Services Corporate Environmental, Health & Safety at Patheon: “Toxicological Principles of Banding”
Jeff Dinyer – Director, Environment, Health and Safety, North America and Global High Potency at Patheon: “Containment Trends and Practices
All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive disposable systems exclusively. Using the latitude available in cGMPs for 21st century, scientific data evaluation, and risk-based approaches can streamline the process. By developing sound and defensible programs with rapid and specific testing, cleaning validation can be efficiently and effectively implemented. This webcast will:
• introduce the science-driven risk-based guide for cleaning validation being developed by ISPE;
• discuss practical considerations for implementing cleaning validation programs; and
• highlight the speed and efficiency benefits of LC/MS for development and execution of cleaning test methods.
Industry Professor at Stevens Institute of Technology
Title: “Cleaning Validation for the 21st Century: Overview of New ISPE Cleaning Guide”
Geoff Carr, Ph.D.
Director, Analytical Development, Patheon Inc.
Title: “Use of LC/MS for Testing Cleaning Validation Samples”
Recorded Webcast: Overcoming Challenges in Developmentof Oral Enteric and Controlled-Release Dosage Forms
Enteric-coated dosage forms are designed to resist the destructive action of gastric fluid and to disintegrate in the higher pH environment of the intestinal fluid. This need may arise if the API degrades upon exposure to an acidic environment or causes irritation of the gastric mucosa. The complexity of developing a controlled-release dosage form increases for drug molecules that possess narrow therapeutic windows, and where absorption site is in the upper or lower part of the small intestine and/or colon. Some small and large molecules further need solubility/permeability enhancement at the intestinal pH range while others need to be protected from moisture in solid dosage form, thus requiring multiple layers of coating – enteric, moisture barrier, controlled-release,etc.
During this 60-minute interactive webcast, three industry experts will discuss challenges and case studies in the development of enteric and controlled-release properties in a variety of solid dosage forms such as multi-particulate, tablets, capsules, and softgels.
Anil Kane, Ph.D., Executive Director,Global Formulation Sciences, PDS, Patheon
Nazaneen Pourkavoos, Ph.D. , Director, Formulation Development, Patheon, High Point
Jason M. Vaughn, Ph.D., Director, Formulation and Product Development, Patheon, Cincinnati
4721 Emperor Blvd
Durham, NC 27703-8580
+1 919 226 3200
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