INSIGHTS ON PHARMACEUTICAL PRODUCTION

• Upstream Considerations For Biosimilar Development

  Understanding upstream challenges during biosimilar development and creating a strategy to overcome them is critical for ensuring a high chance of success with your biosimilar product.

• Enabling Lyophilization Scale-Up From Formulation To Full Commercial Production

  Biologic drugs have shown great promise in curing many life changing diseases, even some that were once thought incurable. However, due to the sensitive nature of  biological material it requires specialized development and manufacturing processes. Stabilization by lyophilization is attractive to retain the product’s biological activity, structural integrity and homogenous quality, all of which are crucial to the success of the product. This white paper describes the challenges associated with lyophilization of biologic drug products.

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

  Learn how a drug developer collaborated to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators.

• High Viscosity Formulations: Developing An Effective Primary Drug Container System

  The past few years have seen a significant increase in the number of high viscosity (HV) formulations (100 – 1000 cP) being developed. There are a number of steps that autoinjector developers can take to meet the challenges posed by such formulations. This white paper focuses on some of the techniques used to develop the ArQ™-Bios high viscosity platform.

• Key Considerations: How CDMOs Can Maximize Productivity And Scalability

  9/21/2021

  Urgent demand for new vaccines and treatments has increased the biopharmaceutical industry’s need for resources in a way that requires transformational operational changes to address. To meet this demand and accelerate the delivery of lifesaving medicines, the industry must maximize development and manufacturing efficiencies, as well as increase production capacity, while maintaining high quality and minimizing risk.

• Mixing Efficiencies For The 2,000 L HyPerforma Single-Use Mixer

  8/3/2021

  In this application note we demonstrate the mixing capabilities of the Thermo Scientific™ 2,000 L HyPerforma™ Single-Use Mixer (S.U.M.) for various applications and to determine optimal mixing parameters. Five different mixing studies were performed to show how the 2,000 L HyPerforma S.U.M. performs complete, rapid mixing that can be used in a variety of large-scale upstream and downstream processes that contain a wide variety of materials, ranging from liquids, floating solids, sinking solids, and viscous liquids.

• Key Considerations When Selecting A Manufacturing Execution System

  12/21/2020

  For the last two decades, Manufacturing Execution System (MES) has been a hot topic at nearly every automation conference and for good reason. MES is a powerful tool that can deliver process efficiencies, yield improvements, cost avoidances, right first time, and much more.

• AES Faciliflex Module

  1/4/2021

  AES Clean Technology introduces Faciliflex Module, a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.

• Vaccine Bioproduction: An Industry In The Spotlight

  7/6/2021

  The pressure continues for manufacturers to quickly produce approved vaccines in unprecedented volumes. Learn about the challenges of sourcing critical process materials from reliable suppliers, and how consistency and collaboration are required to ensure a reliable supply of bioprocess materials.