OOS (Out of Specification) refers to a product that does not meet the established specifications as expected. OOS investigation determines the actual cause of the results.
The plenary session for this session is the same as the ‘Novel platforms’ session in the ‘Engineering antibodies’ track, featuring Enkelejda Miho and Rebecca Croasdale-Wood on benchmarking the impact of AI biologics discovery and optimisation for pharma. Thereafter, there will be another three...
This direction is embedded in the language contained in Title VII, Drug Supply Chain, and Title X, Drug Shortages. Specifically, Title VII Section 705 of the Act states that the FDA “shall inspect establishments described in paragraph [1] that are engaged in the manufacture, pre...
Within this review, the characteristics of novel drug delivery systems based on HA-SH are summarized and the versatility of this polymer for further applications is described by introducing numerous relevant studies in this field. Keywords: thiolated hyaluronic acid; hydrogel; mucoadhesive; ...