Articles in this Issue
Isolation technology has significantly improved our ability to manufacture sterile drug products aseptically. Its performance far exceeds that of other aseptic technologies and has been successfully demonstrated for more than two decades in numerous installations worldwide. Implementation of aseptic-like monitoring and assembly methods is unwarranted when the root-cause for these is correctable by more direct means.
Drug molecules are becoming more complex. As pipelines continue to be dominated by poorly soluble compounds, the dynamic of solubility and absorption will remain central to development success.
How is it possible that multiple generations of aseptic manufacturing are simultaneously cGMP? The simple answer is they cannot be. For any technology there is at any point in time where a pinnacle of performance can be identified by looking at the data.
Oral bioavailability denotes the fraction of a drug taken orally that arrives in the systemic circulation as an unaltered, active form, and is capable of providing its therapeutic benefit. It is typically presented as a percentage of the amount that enters the bloodstream compared to the administered dose.
Evidence-based decision making in medicine, education, law enforcement, economics, public policy, etc. have frequently shown that current practices may be plain wrong, not cost effective, or even damaging to the public good.
Maturity can only be achieved by balanced weighing of strengths, benefits and weaknesses from an assessment and then smart implementation with pragmatic validation and knowledge building.