Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring.
The Trump administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.
This may seem a complex question to answer as you begin your serialization journey. It is difficult to look beyond the significant challenges that lie ahead in this undoubtedly complex project — initial funding and stakeholder engagement, vendor selection and delivery adherence,
When conducting cleaning validation studies at large biologics or biotechnology facilities or perhaps even conducting a small cleaning validation study on a non-dedicated piece of equipment in the same industry; what soil do you choose as your worst case or challenge soiling solution? Multiply that quandary by making all of the process solutions non-toxic and naturally occurring biologics. By Alfredo Canhoto, Associate Director Technical Solutions Practice, ProPharma Group
There are numerous solutions available to ensure effective process validation at sites within a global network. No matter the solution, a comprehensive process validation strategy is necessary.
Degraded samples are common and certainly problematic for investigators. Read more about common causes of degradation as well as agents and systems available to protect against freeze–thaw.
Perhaps the most popular method for producing solid dosages is tablet manufacturing.
Working in a cloud-based information management and collaboration workspace provides a level of business agility and security that is not available with server-based, on-premises infrastructure.
Two significant trends in biopharmaceutical production are coming together. For years, single-use systems have been gaining traction as a way to make processing of biotherapies more efficient. More recently, the industry has also been eyeing continuous manufacturing options to replace traditional “batch” processing methods — again, with the goal of obtaining greater efficiencies.
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