Ben Wylie, senior product manager at ChargePoint Technology, argues that single-use (SU) technology is central to helping biotechs optimise efficiency in order to meet fast-growing demand for biologic treatments.
Biopharma
The biopharma sector is expanding faster than ever before. In Europe alone, the market is expected to grow at a CAGR of 8.89% to reach $67.76 billion by 2025, up from $44.26 billion at the end of 2020. This rise in demand for biologic treatments is being driven primarily by growing diagnoses worldwide of chronic conditions, such as diabetes and cancer, particularly in North America and Europe, where populations are ageing rapidly.
The growth in the biopharma sector in recent years has led to a significantly increase in the need for aseptic manufacturing in turn. As a result, the sterile processing market was estimated to be worth $62.2 billion in 2020, and is expected to expand considerably over the next half decade to meet rising biologic demand.
Biopharma treatments are particularly reliant on sterile processing for a key reason. Such therapies are most often administered parenterally to patients, which means that additional steps must be taken to ensure the drugs and the packaging and devices they come in remain sterile and safe for patients to use.
This requirement for sterile treatments poses a challenge for drug developers as they work to meet surging demand. They need to take steps to achieve an aseptic processing environment at every stage in production all without compromising on efficiency in order to increase productivity and output.
Single-use is the answer
For a growing number of drug developers and their contract development and manufacturing organisation (CDMO) partners, the answer to this conundrum is the use of hybrid, single-use (SU) technologies in their aseptic processing.
One such example is the use of SU chargebags for handling and transferring powders. These film bags are made of a high purity polyethylene liner and are specially designed for use in sterile pharmaceutical and biotech applications, being used once, before being disposed of and replaced with a new, sterile bag.
Such bags can be attached to standard powder processing equipment via the passive component of a split butterfly valves (SBV). Once they are attached, they are ready to be filled with powdered product from the production line. They can then be used to transfer the product to the next stage in the manufacturing process, either within the same facility, or at a new site.
In addition, disposable passive SBV components can be used in place of standard re-useable SBVs. These can be thrown away with the SU bag after use, and replaced with a new component.
Addressing productivity challenges
This new generation of SU biopharmaceutical production line equipment is a key innovation in the sterile manufacturing arena. It addresses a key challenge posed by standard re-useable bags and other components – that of production downtime for washdown.
This SU technology is designed to be used once prior to disposal, which means they do not have to be included in cleaning and washdown procedures between batches of biologic powders. All that line operators and engineers need to do is replace them with new components after use. This can significantly streamline the hygiene procedures needed to maintain sterility compared with re-usable alternatives, reducing production downtime and enhancing efficiency.
As a result, SU bags and other equipment can ensure the aseptic integrity of products during transfer within and between manufacturing facilities. They can maintain optimum product quality, while streamlining production processes and minimising manufacturing cost.
Maintaining aseptic integrity with SU
To ensure optimum sterility, all SU bags and similar SU components are manufactured within an ISO6 cleanroom environment and are gamma sterilised prior to use. By undergoing all of these processes, they are suitable for use in the most rigorous aseptic processing environments, such as those required for parenteral treatment production.
In addition, SU bags are designed to connect seamlessly with the disposable passive component of a single-use SBV. This can eliminate any risk of the ingredient within the bag being exposed to the external environment. As a result, it can allow the contained and sterile transfer of pharmaceutical powders between each step in the manufacturing process, as well as between different facilities, during a tech transfer.
Minimising obstacles to implementation
Unlike other new equipment or technology, it is simple and straightforward to integrate SU bags and other components, such as SU SBV parts, into an existing production line or manufacturing process. Advanced SU equipment has been designed to easily replace traditional re-usable alternatives without the need for extensive technical upgrades to existing production lines.
They also require minimal training for line operators to be able to handle and fit between batches. This simplifies both the initial integration process when incorporating the equipment for the first time, and further reduces downtime between batches when replacing the used components with new ones.
With all of this in mind, they present a highly effective alternative for manufacturers looking to enhance the efficiency of their aseptic processes.
The secret to streamlined aseptic processing
The biopharma space presents exciting opportunities for drug developers looking to create innovative treatments to transform the lives of patients for the better. It’s no surprise, then, that it is growing so quickly.
In order to continue to meet fast-rising demand for biopharma production, it is vital that manufacturers take steps not just to invest in expanded aseptic production capacity, but to maximise the productivity of their existing lines as well.
SU equipment is a creative solution to optimise efficiency on both new and existing lines while maintaining aseptic integrity. By reducing the downtime required for washdown and hygiene processes between product batches, they can help significantly boost output while also ensuring optimum levels of sterility.
As a result, they can ensure they deliver the expanded manufacturing capacity to meet developers’ growing needs without compromising on the quality of the product they are processing.