DPT’s comprehensive archives of published articles provide insight into various aspects of pharmaceutical outsourcing, drug manufacturing, research and development and many other topics.

QUALITY-BY-DESIGN – Quality-by-Design: The Good, The Bad, The Inevitable

To bring new ideas and innovations into the real world, science has to be made into something tangible. While that’s the fundamental mission for many pharmaceutical companies, that’s exactly where many drug development programs fall short – in the actual formulation, engineering, and production of new products. This is evident as the US Food and Drug Administration (FDA) continues to emphasize the “modernization of the regulation of pharmaceutical manufacturing and product quality.” Poised to be the key driver of that mission is Quality-by-Design (QbD).1

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Materials Sourcing: Managing the complexities of global supply chain

With the increased globalization and accompanying complexity of the pharmaceutical supply chain, managing the role of materials sourcing has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve. Current trends have forced life science industry companies to more rigorously optimize sourcing activities for raw materials, intermediates, active pharmaceutical ingredients (APIs) and other material components for both clinical supplies and commercial manufacturing. If managed improperly, sourcing can result in supply chain interruptions, significant unexpected expenses and quality control issues. As companies increasingly rely on highly qualified contract development and manufacturing organizations (CDMOs) to manage the sourcing role, how can you ensure effective sourcing?

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Formulation and Characterization of Nasal Sprays

Recently, specially-designed drug delivery devices have emerged that can administer sprays or powders to the olfactory region of the nose, thereby bypassing the blood-brain barrier and enabling delivery of the drug directly to the central nervous system. This article examines nasal spray formulation development parameters and excipients and their influence on key in vitro tests.

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Building Flexibility, A New Business Model for a Volatile Industry

Working with a contract development and manufacturing organization (CDMO) with expertise in all the services you require ensures greater service uniformity, efficiency and collaboration throughout all processing stages. CDMOs can provide the processes, technology, specialized intelligence and rapid response to changing needs that can give you a competitive edge. They enable sponsors to rapidly scale drug development and manufacturing operations up or down and add specialized capabilities, accommodating flexible scheduling and volume spikes. As such, sponsors outsourcing effectively to a CDMO can move to a more variable cost structure while accessing more drug development and manufacturing expertise than if they kept everything in-house.

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Strategies for Becoming a Preferred Provider

DPT senior vice president of sales & marketing, contributes to Pharmaceutical Technology’s article titled “Strategies for Becoming a Preferred Provider” and the growing emphasis throughout the pharmaceutical outsourcing arena on being a strategic, or preferred, provider. In the article Paul explains how contract manufacturing strategic partnerships allow a sponsor to gain greater supply chain visibility by more tightly integrating a CDMO into its operations.

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