INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• Leveraging Innovative Technologies, Best Practices And Strategies To Accelerate Biologics Development And Commercialization

  Gain insight into how practical implementation of innovative technologies and solutions such as multi-attribute method, modernized cell line development workflow using high-yield cell lines and automated systems, as well as next generation purification resins help to accelerate biologics development and commercialization.

• Multiplexing: Managing Risk With Proven, Single-Use Solutions

  Typically, demand forecasts for drugs prior to launch reflect a huge range of expectations. This illustrates just how hard it is to forecast accurately. Instead of trying to make better predictions (which will never be wholly accurate nor truly able to remove risk), or erring on the side of overcapacity (which is a drag on ROC), developers and CDMOs should seek manufacturing flexibility.

• Does Your CDMO Have Sustainable API And RSM Strategies?

  To prevent costly delays in your timeline, you must be sure the CDMO you select has appropriate oversight of their RSM and API manufacturing supply chain.

• How Intelligent Collaboration Transformed A Generic Into A Best-In-Class New Drug

  A pharmaceutical developer specializing in leveraging common compounds for new indications needed to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators. Read how collaboration and the drive to find a workable solution led to a successful drug development program.

• Making The Medicine Go Down: Specialized Oral Solids Delivery Technologies

  Most oral solid formulations are designed to release the drug immediately after swallowing for rapid absorption into the bloodstream. However, some products have been developed to release the drug in a specific way following ingestion and provide a “controlled-release” of the drug products. In this article, Sandra Conway, Technical Lead at Pfizer CentreOne discusses some of the drug development technologies that provide a more specialized approach to oral dose delivery.

• The Importance Of End-To-End Thinking During Drug Product Development

  Throughout a drug product development program it is important to build robustness and flexibility into the manufacturing process. In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

• Technology Selection For Capsule-Based Inhalation Product Development

  This webinar explores the technical issues that must be explored for successful development of effective capsule-based inhaled drug products. Key design considerations are discussed, including formulation attributes; technology selection (e.g., spray-drying, micronization); and capsule and device considerations. To learn more, please view our presentation.

• Particle Engineering For Inhalation Drug Delivery

  Inhalation-based drug products play a critical role in addressing the rising incidence of respiratory diseases around the globe. Particle engineered-based formulations are key in designing and developing effective dry powder inhaler (DPI)-based drugs. This article discusses key parameters for choosing the right particle engineering approach to meet DPI target product profiles.

• Engineering Approaches To Respiratory Drug Delivery: Mannitol Case Study

  Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products. This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol. Read our article to learn more.