Biomedical Engineering Reference
In-Depth Information
Staying within the viral clearance design space will require communication among
functions such as process development, validation, and manufacturing. Collectively,
these functions will possess the information required to make the correct decision to
maintain regulatory compliance and product safety.
8.7 CONCLUSION
QbD and design space implementation challenges the industry to develop and present
a strong knowledge of the virus clearance capabilities of their manufacturing process-
es. Very few biopharmaceutical manufacturers have the resources to build compre-
hensive virus clearance design space understanding on their own. Therefore, the
change to a QbD and design space philosophy also challenges the regulatory
community and the industry to enter partnerships to augment collective understanding
in the field of virus clearance. That collective understanding may be enhanced by the
following measures:
.
Compilation of existing data, such that the industry can transform data into a
knowledge base for the application of virus clearance technology. This effort may
also uncover issues that require further understanding.
.
More academic studies that further elucidate mechanisms of viral clearance for
technologies for which that information is still limited.
.
Studies to establish levels of equivalence among viruses. Particularly beneficial
could be the identification of bacteriophages that show similarity to mammalian
viruses with respect to susceptibility to virus clearance technologies.
.
Cooperative efforts aimed at creating standardization in areas such as virus assays
and virus spike quality attributes.
Currently, the industry has the required technical tools and regulatory guidance to
incorporate well-controlled virus clearance unit operations into biopharmaceutical
manufacturing processes. As more information is shared in the biopharmaceutical
industry and knowledge bases are augmented, the collective ability within the industry
to design and control more well-characterized processes will increase. The benefits of
increasingly stronger process characterization and understanding are mutually shared
among the industry, regulators, and patient populations.
ACKNOWLEDGMENTS
The polymerase chain reaction is covered by patents owned by Roche Molecular
Systems and F. Hoffman-LaRoche. A license to use the PCR process for certain research
and development activities accompanies the purchase of certain reagents from licensed
suppliers. Sepharose is a trademark of GE Healthcare companies, GE Healthcare
Bio-Sciences AB, a General Electric Company, Bjorkgatan, Uppsala, Sweden.
