Dr Kevin Robinson recently caught up with Ben Wylie, Head of Product Management and Marketing, ChargePoint, to pose the question: how do you solve the process optimisation equation of speed-to-market and cost efficiencies while maintaining a safe environment for both operators and end users?
Pharmaceutical companies are looking for more efficient ways to advance their new treatments to market as quickly as possible while ensuring optimum quality. The nature of biologics means that they must be delivered parenterally, and this requires them to be manufactured in a sterile environment.
But, ensuring this sterility for new biologic drug products poses significant challenges to pharmaceutical companies.
With the latest amendments from Annex 1 to good manufacturing practice now finally in place, manufacturers must also take additional steps to minimise the number of manual interventions in cleanroom processes to ensure both compliance and optimal sterility.
These sterile operations require highly specialised equipment, training, infrastructure and operating processes to be employed within cleanrooms, which can be costly and time consuming to implement, impacting speed to market.
More companies are adopting single-use technologies to ensure compliance, with the global single-use market expected to reach a compound annual growth rate (CAGR) of 16% by 2028.
The application of single-use technologies forms a key part of investment strategies for new biopharmaceutical lines to help ensure optimum regulatory compliance while minimising downtime from extensive cleaning.
These technologies include single-use split butterfly valves (SBVs) and aseptic powder transfer bags, which offer highly effective ways to streamline bioprocessing operations.
These technologies replace their stainless steel and reusable counterparts and can be disposed of after use, eliminating lengthy cleaning and validation procedures and ensuring uncompromised sterility.
They also require minimal training and expertise to install, streamlining time-consuming washdown procedures, reducing operational downtime and boosting efficiency throughout production lines.
Furthermore, these technologies fit onto existing production line equipment, eliminating the need for expensive upgrades to key infrastructure when preparing lines for the commercialisation of new biopharma treatments.
Pharma companies can also implement the latest smart factory technologies (SFTs) into their production lines to further optimise their speed-to-market while ensuring optimum performance across sterile production lines.
Technologies such as smart monitoring solutions can help to provide manufacturers with real-time data on the equipment being used and alert them when maintenance or cleaning may be required.
Operators can then make the necessary adjustments as needed to keep bioprocessing lines running smoothly — while ensuring that any potential sterility risks are minimised.
As a result, these innovations can help to lengthen the lifespan of manufacturing equipment, helping to reduce operational costs and ensure sterility during every stage of production.