Speeding products to market requires a precise balance between efficiency and compliance. By streamlining complex workflows, a centralised and automated approach to batch release will improve patient access to innovative treatments.
Novel therapies offer the exciting prospect of treatments for previously incurable diseases. Since many of these are greenfield, life sciences companies must grapple with new suppliers and processes for manufacturing and testing while ensuring continuous control and visibility.
Speed is critical for patients waiting for innovative treatments. However, complex supply chains challenge organisations to keep efficiency and compliance in constant equilibrium. Quality leaders are responsible for delivering products to market that meet the required standards, but typically make batch release decisions by pulling electronic records from several disconnected systems. This fragmented approach is counterproductive to revenue goals, introducing regulatory and data integrity risks that lengthen overall time to market.
Better outcomes are achievable when data aggregation and review are automated and centralised. Automation and data-driven technologies will support wider industry goals, such as BioPharma 4.0, to speed new therapies for patients.
Novel Sciences, New Challenges
Life sciences companies are broadening their remit to new modalities. Cell and gene therapies (CGT), for example, introduce complexities including variable materials, limited batches and shorter shelf lives, to name a few. Whereas traditional small-molecule programmes are likely to have 18 to 48 months until product expiry, the window between final manufacturing until dosing of the patient could be just 72 hours for CGT products.
