Buffers are essential in all stages of the production of biological drugs, and therefore important for every manufacturer. Managing the logistics and large number of components involved with buffer manufacturing and storage requires extensive amounts of time and labour, as well as facility space. This has led to an increase in the number of manufacturers seeking alternative options to in-house preparation.
The decision whether or not to outsource buffer preparation is not clear-cut but provides an opportunity to balance risk with reward. Irrespective of the size of the organization and in-house capacity, outsourcing can:
- Help increase process efficiencies
- Reduce risk by simplifying and standardising workflows
- Help decrease operating cost, and improve quality, compliance and productivity
- Free up valuable skilled staff, as well as space, for value-add tasks
In general, outsourcing is an increasing trend that has been emerging in the industry over the last six years, and buffer preparation is an obvious candidate for many organisations. This is particularly true for downstream processes, where the volume and number of buffers required for multiple purification steps is significant and complex.
Even when batch sizes are small (e.g. for research or cell and gene therapy applications), there are significant benefits to be gained from outsourcing buffer supply. It can enable organisations to stay capital-lean and maximise their limited resources most effectively. It also lays the groundwork for easy scale-up and provides an assurance of supply.
The clear opportunities offered by outsourcing are accompanied by concerns such as a sense of loss of control, a risk that quality may deviate from what is expected or required, or a potential lack of integration with your own processes. However, these issues can be reduced or eliminated with thoughtful planning and collaboration.
When outsourcing, there is no one-size-fits-all but a continuum of available options, and ways to minimize the risks. When this decision is approached in the right way, there is huge potential to make operations more economical and efficient. There are also a number of advantages that are afforded by supplier programs (such as safety stocks and excess inventory), which should be factored into the decision-making process. In addition, manufacturers can benefit from enhanced quality control and efficiencies of scale that may be otherwise difficult to achieve.
Benefits to gain from outsourcing
Reduce testing, ensure quality
When deciding to outsource, it should be kept in mind that there is an extensive amount of work that can be done by the supplier. Responsibility for procurement and QC testing of salts, liquid preparation, filtration, quarantine and finished good testing, as well as all the documentation, procedures, validation and training that accompany these, are all removed when outsourcing. Simply managing all aspects of the buffer production process and scheduling these to fit ‘just-in-time’ product manufacturing processes are tangible benefits that can also be gained.
Buffer performance does not need to be compromised. Selecting an outsource partner with a robust quality management system and employing high-functioning process and continuous improvement approaches will ensure the production of the highest quality buffers. Product consistency can be enhanced by preparing buffers in the larger batch sizes that are achievable when outsourcing, compared with the multiple, smaller batches that are often produced when buffer is prepared in-house. This coupled with in-depth knowledge of liquid stability can potentially enhance buffer performance.
Maximize facility footprint
Buffers are the largest component of downstream processing by volume and, as such, storage can be a challenge for many manufacturers. The need to store 25,000L of ready-made buffer, for example, creates a large amount of facility dead space. Even with appropriate temperature warehousing, once prepared, every buffer has a shelf life after which it becomes unviable. Preparing and storing buffer in-house risks wastage and loss of investment if the full amount of the buffer cannot be used in time.
Buffer preparation and storage for a standard monoclonal antibody can require up to 30 percent of a facility’s valuable floor space, which could be otherwise used to expand manufacturing capacity. A simple solution to reclaim some or all this footprint is to outsource buffer preparation entirely, eliminating the need for mixing tanks and their maintenance, with the added benefit that capital and operating costs are reduced as a result.
Utilising an outsource partner’s cGMP warehousing and taking advantage of just-in-time delivery, so that only the right amount of buffer is delivered exactly when it is needed, significantly reduces on-site storage needs. Removing these constraints opens up the opportunity to repurpose facility usage and support growth.
Benefit from additional support and insight
Accessing a partner’s depth of experience and understanding can be invaluable. For example, a chemical capability team can highlight any concerns about solubility limits or other formulation challenges. They can also provide critical insights on appropriate packaging and help avoid mechanical failures or exposure to any unwanted extractables or leachables.