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The innovation of single-use technologies is applicable early on in the manufacturing process.
Containment of ingredients and materials during bioprocessing is necessary for the protection of the manufacturing environment, the operators working in that environment, and the drug product. Because containment is an ongoing priority for the industry, innovative technologies are needed to support it. For example, as the adoption of single-use systems in bioprocessing grows, the introduction of newer single-use technologies to compliment those systems are helping to streamline aseptic bioprocessing. For instance, single-use bags for transferring powder ingredients (e.g., cell culture media) to the bioreactor are an increasingly useful tool in keeping the loading of the bioreactor a closed process.
It has been historically accepted that sterility is not a critical factor early on in the biomanufacturing process, such as during the transfer of cell culture ingredients, for instance, powder ingredients for media and buffers. Thus, powder ingredients have traditionally been scooped from stock containers and then weighed and mixed in vessels or bags, a process that is typically done in a separate clean room to control contamination from airborne material (1).
However, as biomanufacturers grow to use single-use technologies, single-use bags can also be applied for other tasks besides the cell culture process itself. Single-use bags offer a simpler, cleaner, and safer way to handle ingredients. Dry ingredients can be transferred to single-use bags with the added convenience of having pre-weighed amounts prepared from storage vessels.
To discuss the challenges and practicalities of using single-use bags for handling powder ingredients in bioprocessing, BioPharm International spoke with Ben Wylie, senior product manager, ChargePoint Technology, a provider of high containment and sterile powder transfer solutions.
BioPharm: Why is the development of single-use bags for powder handling/powder transfer considered an impactful innovation in upstream bioprocessing? What is their function; how do they work?
Wylie (ChargePoint Technology): The rise in demand for biopharma treatments in recent years has led to a significant increase in the need for aseptic manufacturing. Biologic treatments are particularly reliant on sterile processing due to the fact that they are most often administered parenterally to patients, so additional steps must be taken to ensure they remain safe.
A major challenge facing pharmaceutical companies looking to meet this new market demand for sterile treatments is how to achieve an aseptic processing environment at every stage in production without compromising on efficiency and productivity. For a growing number of drug developers and their contract development and manufacturing organization (CDMO) partners, the answer to this conundrum is the use of single-use (SU) technologies in their processing, such as single-use bags for handling and transferring powders.
Single-use powder transfer bags are made from a high purity polyethylene (PE) film liner and are specifically designed for use in pharmaceutical and biotech applications. They are utilized in bioprocesses for the safe and efficient transfer of media powders and for buffer powders. Downstream, in fill/finish applications, the bag forms part of a complete closed transfer system for the sterile transfer of API powders to the formulation process.
BioPharm: What ‘old school’ challenges or issues do these single-use bags address and/or fix for biomanufacturers?
Wylie (ChargePoint Technology): This new generation of SU equipment is a significant innovation in pharmaceutical development, addressing a key challenge posed by standard multi-use containers and other components—that of production downtime for washdown.
As they are designed to be used once prior to disposal, SU bags and other equipment do not have to be included in cleaning and washdown procedures between batches. All that is required is for them to be replaced with new components. This can significantly streamline the hygiene procedures needed to maintain sterility compared with reusable alternatives, reducing production downtime and enhancing efficiency.
All of this means that 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 helping to maximize process efficiency and reduce production costs.
BioPharm: How do these bags play a role in maintaining aseptic conditions for bioprocessing?
Wylie (ChargePoint Technology): SU bags and similar SU components are manufactured within an ISO6 cleanroom environment and are gamma sterilized prior to use when required. As such, they are suitable for use in the most rigorous aseptic processing environments.
SU bags can be designed to connect to the disposable passive component of a single-use valve, (e.g., Split Butterfly Valve [SBV], ChargePoint Technology) to enable the contained and sterile transfer of pharmaceutical powders between each step in the manufacturing process, as well as between facilities. The passive half doesn’t need to be cleaned after use because it can simply be disposed between fillings, increasing productivity.
Traditional multi-use containers and other components, on the other hand, would have to be washed thoroughly between batches, alongside the washdown of the rest of the line, increasing downtime and the time and headaches often associated with validating cleaning procedures. SU bags help to minimize washdown requirements, reducing production downtime. As a result, they maintain the highest standards of aseptic processing while optimizing manufacturing efficiency.
BioPharm: Does switching to these single-use powder-handling bags pose their own challenges, and if so, what are they?
Wylie (ChargePoint Technology): Generally, the time and complexity in adoption of any new single use component lies in the up-front work to qualify the materials and build a robust supply chain. However, this effort pays dividends in the long run with clear benefits in being able to deploy pre-qualified solution off-the-shelf as required. Typically, this solution is easy to retro-fit to an existing process and requires minimal training for line operators to be able to handle and fit.
With all of this in mind, single use components present a highly effective alternative for manufacturers looking to enhance the efficiency of their GMP [good manufacturing practice] and even aseptic powder handling processes.
BioPharm: Can you explain the cost and overall operating benefits that single-use powder-handling bags offer (if not already addressed)?
Wylie (ChargePoint Technology): As explained in previous questions, SU bags and other disposable equipment can significantly improve manufacturing efficiency during aseptic processing by reducing the downtime required for washdown and hygiene processes between product batches. By using such components, manufacturers can optimize output on their lines, maximizing manufacturing capacity without compromising on product quality.
1. C. Rombach, “Facing the Challenges: Single-Use Approaches to Powder Transfer,” ILC Dover White Paper, www.ilcdover.com, accessed March 22, 2021.
Feliza Mirasol is the science editor for BioPharm International.
Vol. 34, No. 4
When referring to this article, please cite it as F. Mirasol, “Single-Use Bags Help Maintain Aseptic Ingredient Transfer to Bioreactors,” BioPharm International 34 (4) 2021.