A growing number of biologic manufacturers are adopting new fill-finish technologies, including single-use systems, pre-filled syringes, and automated fill-finish systems. When doing so it is critical to also consider the cost-benefit tradeoffs.

Demand to increase speed and flexibility while maintaining sterility spurs the adoption of novel technologies and materials, all of which introduce new challenges.

Single-use technology is well-established and made its way into commercial licensed facilities, but there is more innovation in this field which will enhance its versatility into new markets and technologies.

The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment. Using a combination of financial options analysis and decision analytics to quantify your options helps to embrace the uncertainty equation.  

Biopharma manufacturers seek dynamic processing economics that address the paradigm shift from blockbuster drugs with established production schemes to small-scale manufacturing and innovative tech.

Flexible and modular facility designs that can be built in a factory, shipped to the site and then rapidly assembled have been recognized and are being addressed by innovative suppliers.

Single-use technologies are being seen as the solution to flexibly and cost-effectively address many of the challenges around creating biologics manufacturing capacity.

The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity can will meet your long-term needs.

<p>If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital. Where you don&rsquo;t have this knowledge in-house, finding a supplier with first-hand experience of operating in a region can help fast track your project.</p>

In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.