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.

PHARMACEUTICAL PRODUCTION SOLUTIONS

  • ArmorFlex® 104 was developed in 1997 and has been in use by pharmaceutical manufacturers globally ever since. Proven in myriad applications, ArmorFlex® 104 supports processes from wetcake to dry powder storage and transfer.

  • Asahi Kasei Bioprocess is dedicated to unlocking efficiencies and driving productivity within your biopharmaceutical and plasma derivative virus filtration processes. We also understand that the adaptability and reduced capital expense afforded by single-use systems are preferred in many facilities. By uniting single-use technology with our viral safety know-how, we can help you achieve peace of mind through the implementation of our tried-and-true Planova filters in a relatively simple and flexible manner.

  • AbbVie Contract Manufacturing offers development to commercial manufacturing services for prefilled syringes at our Barceloneta and Lake County facilities. Barceloneta is one of the world’s most advanced facilities for biologics syringe filling and Lake County has broad packaging services from blister packs to auto-injectors.

  • Used Quadro Yton blender, model ZC1, stainless steel construction, nominally rated 3-12 gpm, up to 30#/minute powder capacity, with powder funnel, driven by 7.5 hp, xp motor, 1" inlet/outlet, skid mounted with Idex rotary lobe pump, model 0300, Quadro serial# ZC1-0311, built 2009.

  • With patients’ lives at the end of the pipeline, biologics contract manufacturing needs to be safe, reliable and consistent in supply. The developers of these large molecule drugs, however, are also operating in a highly competitive space. Speed-to-market is imperative, along with efficient processes and low costs. A lot of this will rest on the quality of the cell line development and the expertise of the biologics CMO you choose.