Microcarriers are commonly used in bioreactor cultures to provide a large growth surface for anchorage-dependent cells, and are typically provided either untreated or gamma-irradiated and ready for use.
Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.
The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.
Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.
This application note describes a process for rapid production of recombinant anthrax protective antigen (rPA) in short process time for the manufacture of an anthrax subunit vaccine.
Through proper planning of your automation integration, you can eliminate costly errors and missteps and focus on developing efficient, future-proof automation strategies.
A customer enlisted Catalent to support their child-resistant blister packaging requirements for a global Phase III study. A flexible design was created with an integrated blister card that could also support larger study requirements of 1.9 million monthly dosing cards. Through customized commercial blistering equipment a solution was provided that would accommodate the customer’s growing demands for clinical supplies.
It’s been more than 30 years since monoclonal antibodies (mAbs) were first licensed for clinical use. But product developers are still inventing novel ways to improve their safety and efficacy.
Selecting a partner is challenging, but with the right information you can simplify your efforts and increase your likelihood of making the best decision.
Critical quality attributes (CQA) are fundamental to regulatory compliance and in drug development and manufacturing. Find out how surface plasmon resonance has been applied for protein characterization of antibody effector function.
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