Current Podcast
Making a Business Case for PAT and QbD Implementation:
Brett Cooper, MSD Development Laboratories, speaks about the key benefits of PAT and QbD implementation and the biggest challenge pharma and bio companies face regarding the interpretation of regulatory guidance. Cooper also discusses how to prove the business case for PAT and QbD implementation.
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Other Podcasts
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In this podcast, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some great insights into the commercial manufacturing scale-up process of cell therapies.
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Sudip Kumar Majumder, Principal Scientist at Intas Biopharmaceuticals India, speaks about streamlining and redesigning the downstream process and innovations on the horizon that will change the current state of play for biopharmaceutical downstream processing.
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Dr. Barbara J. Potts, Senior Consultant, Potts and Nelson Consulting, Pharma, IQ to discuss the biggest threats to the safety of biologics and which contaminants present the most problems. Potts also shares her insights on common myths surrounding mycoplasma and why they persist, developments in PCR kits and how to ensure the safety of raw materials.
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Richard Loughlin, Director, Contract Manufacturing Business Development North America, Commercial & External Partnerships (CEPiA) sanofi aventis, joins Pharma IQ, to discuss contract manufacturing trend, the main advantages of using a CMO to enter a new market. Loughlin also shares his top 3 tips for choosing a new outsourcing partner.
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Eric S. Langer, Managing Partner, BioPlan Associates, joins Pharma IQ, to address how the contract manufacturing sector is adapting to the changing needs of pharma and biotech, the need for access to enabling technologies and how contract manufacturing organisations (CMOs) are increasing their client services capabilities- focusing on not only how to meet technical and scientific challenges but also how to deliver value more effectively to the client.
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Stephen Brown, CTO of Vivalis and a Member of the Single Use Task Force, PDA, discusses the application of risk management strategies when implementing single-use systems (SUS). First Brown outlines how best to implement a full SUS and the vital ingredients for effective supplier selection criteria and stakeholder management solutions. Looking at the risk management process, Brown offers some tips for other organisations when it comes to development and execution. He also offers some do’s and don’ts on how to successfully enhance the product lifecycle and achieve process validation. Finally, he highlights some developments in the pipeline for disposable solutions – and the challenges that must be overcome for these to come on stream.
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Tim Chesworth, Team Manager - Packaging & Devices at AstraZeneca, speaks about delivering patient compliance through user focused development of delivery systems. Chesworth discusses the key drivers of the pre-filled syringes and injectable technology market, the key challenges to be addressed in patient compliance and why it is so important to understand the user’s needs when developing delivery systems.
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Dr. Caspar Schatz, Manager for Optical, and In Process Control, Roche Diagnostics GmbH, discusses developing and evaluating container closure testing systems. Schatz outlines the different approaches to monitoring syringe closure in the manufacturing process to ensure full integration; ways of applying automated process analytical procedures, and the main challenges faced to put them into practice effectively. He also gives an overview of the main regulatory requirements for those working with prefilled syringes and injectable technology and offers some tips on how to prove the integrity of all components.
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Aurore Poles Lahille, Assistant Scientist and Specialist in New Technologies and Manufacturing Support at Merck Serono Biodevelopment, joins Pharma IQ, to discuss a comparative analysis of single use bioreactors. Poles begins with an overview of the comparative study – the rationale, challenges and results, before talking about the criteria used to assess whether the SUB is right for a particular system and the best integration approaches.
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