- Part 31: For the preceding part double click ID:nRSH4027RD
parameters to ensure the product conforms with its safety, identity and
strength requirements and meets its quality and purity
characteristics.Biologics production facilities, especially for drug
substance manufacture, are very specialised and can take years to develop
and bring on line as licensed facilities. Predicting demand for certain
classes of biologics, especially prior to launch, can be challenging. We
expect that external capacity for biologics drug substance production
will remain constrained for the next several years and, accordingly, may
not be readily available for supplementary production in the event that
we experience unforeseen need for such capacity.
Legal; regulatory and compliance risksAdverse outcome of litigation Impact
and/or governmental investigations
- More to follow, for following part double click ID:nRSH4027RF