Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
Safeguarding against microbial contamination requires rapid detection and innovative technology.
Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.
Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?
Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.
A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.
The future of raw material sourcing for mAb production may lay in the sustainability of the source and the added benefits of newer technologies.
While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.
The need for lyophilization services is growing as a burgeoning pipeline of new biologics matures.