A flexible, portable and cost-effective solution to stainless steel, single-use systems have the potential to revolutionize the biopharmaceutical world. But what does it take to manage the design of a single-use facility?
Deciding to transition to single-use systems might seem simple. Be it for reasons related to cost, flexible modular design or unique schedule needs, the benefits abound. However, the motivators must be analyzed in order approach the design process. Break down the design management behemoth of single-use systems into five steps with a focus on analysis.
Identify the unknowns
While the known elements of a single-use system design will resemble those of typical biopharmaceutical manufacturing systems, the unknown factors are unique. For example, the process material balance of a single-use system is not readily defined. The throughput will be different when transitioning from clinical production to commercial production. To meet the demands of the process, you might need ten 500L bioreactors instead of a single 5,000L bioreactor. Never forget that unknowns require clarification of assumptions and identification of gaps in the project definition.
Consider product characteristics
Unlike stainless steel, which has global composition standards, single-use products comprise of many materials, which may not have universal standards. And while it pays to shop around, bags from one company may not be compatible with fittings from another vendor. Bear in mind your bioreactor and bag design and their consonance are critical to quality and cost control.
Determine the critical parameters of your single-use system operation
One of the advantages of single-use systems is their flexibility and ability to scale up or down quickly. However, these decisions about scaling-up or down must be determined early on, as they significantly impact other design process parameters such as temperature, flow rates, tube set and connector characteristics. Often, when determining parameters, answers to bigger questions crop up. Such as the debate of whether to use single-use, traditional or hybrid systems.
Identify and mitigate risk
Risk management is not a unique activity in biopharmaceutical manufacturing. However, there are areas of risk that are especially relevant in single-use systems – in particular, closure analysis and supply chain management. Keep your design on time by identifying uniquely single-use risks early on.
Though one key driver for adopting single-use systems is the option of flexible production, the element of flexibility must be addressed in the design process. This can mean focusing on the multi-stage goal of manufacturing from a single-facility asset. Whether you are working with early-stage clinical manufacturing through launch or commercial manufacturing, the facility design must allow for a flexible segregation strategy, multiple manufacturing platforms and a likely scale increase. Many facilities now take advantage of a modular-based delivery approach, filling the facility with modular units.
Designing a single-use system facility and managing the process is a novel procedure and one that competitors in the new pharma reality must face head-on. However, identifying unknowns, flagging potential risk, asking critical questions and never settling for anything less than concrete solutions will keep the complex design on time and within budget.