With many end users now demanding streamlined operations, high-density culture in fed-batch modes, even higher production by perfusion cultures, and contrastingly gentle operations required in microcarrier applications, standard S.U.B. offerings must keep pace with the ever-evolving needs of the bioprocessing industry. Read about recent enhancements that are helping keep up with these increasing demands.
The advantages of contract manufacturing come with certain practical risks. Many of those risks are associated with inadequate communication and knowledge transfer between the drug’s originator and the CMO. Throughout this paper on CMO risk mitigation, we will approach the subject from the perspective of a sterile drug product CMO and establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.
Tubing is arguably one of the earliest components in the pharmaceutical industry to be associated with single-use technology (SUT). Every component used in biopharmaceutical processing — large or small — is pivotal to the ultimate goal of delivering safe and effective medication. To deliver cleaner materials and actively mitigate risk in biopharmaceutical manufacturing, evaluation of single-use tubing based on the following development principles should take place.
Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.
Companies are moving from stainless steel to single-use assemblies for final filtration allowing them to meet production demands and cut costs. The design of single-use assemblies can be challenging. Learn more about the different options that should be considered to accommodate pre-use integrity testing along with prototype testing and handling considerations.
The costly proliferation of parts and components that often accompanies the pressure for product differentiation and customization can be controlled through multiple strategies. One of the easiest and most effective of these is to deploy EXALEAD Sourcing & Standardization Intelligence. By combining information sources with semantic information, these new products and applications go beyond the limits of conventional analytics solutions and deliver simple user experiences for decision makers.
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
What started out as a simple bag for holding buffers or cleaning solutions has evolved to thousands of single-use products and entire processes. The industry is now calling for standardization.
An organized effort across the biopharmaceutical industry, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.
A combination of strategies to prevent contamination and advanced technologies can optimize performance and mitigate the risks from mycoplasma to your product and the patients it serves.
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