Biotech products, in particular, provide a number of unique manufacturing challenges compared with big therapeutic classes,
such as anticoagulants and vaccines. The trend towards readytouse delivery systems combined with the decreasing manufacturing
volume associated with biotech products and more targeted therapies poses an efficiency challenge. Batch sizes are typically
smaller, requiring potential innovation and manufacturing optimization to provide sustainable value.
Extractables and leachables analysis
For CMOs, there are also complexities related to global regulatory compliance because there are marked differences in the
expectations and best practices of key regulatory agencies. For example, specific structural changes needed for one client
to ensure regulatory compliance may impact others using the same manufacturing line. Finding appropriate solutions to accommodate
the broad spectrum of client and regulatory requirements is an intricate responsibility of utmost importance.
The growth of autoinjectors
As with other sterile filling, such as vials, another challenge that can arise is the need to calibrate automated inspection
equipment to meet the standards of multiple regional regulatory agencies, as well as client expectations. There is also often
a lack of validated data to adequately handle product physico–chemical limitations, such as air and light sensitivity, time-out
from refrigeration, shearing concerns, and others.