Increasing molecular diversity leads to more challenges in process development and control. Advancements in technology for manufacturing and online analytical monitoring have not caught up to the innovative drug candidates and emerging modalities present in the candidate pipeline today. Lack of pre-determined process and analytical platforms for these modalities often translates to longer development times. New modalities are more difficult to fully characterize due to their complexity, and some highly complex tests take weeks to complete. Therefore, failures in quality attributes are typically found post-production after testing is completed.
Supply chain constraints on critical raw materials in the form of lead times of months to years can be another serious bottleneck for production. Cold-chain requirements have also limited global distribution, storage, and access especially in regions with less developed infrastructure.
Biopharma manufacturers must find solutions to enable the acceleration of the development of the diverse array of novel drug candidates in the pipeline and thus ensure that safe and effective novel treatment options can be brought to patients more quickly.