The Case for Outsourcing Buffer Preparation in Pharma

Why manufacturers are seeking alternative options to in-house preparation.

By Dr. Becky Moore, Senior Global Product Manager Bioprocess Liquids; Genevieve E. Brau, Senior Manager, Global Market Development; Remko Clasen, Senior Market Development Manager, Thermo Fisher Scientific

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Additionally, some formulations are more complex than others. This can cause challenges when it comes to preparation and storage. The need to handle caustic or toxic chemicals, or special production conditions such as cold processing to maintain stability, can very quickly drive an escalation in production costs. 

By offering a technical sounding board, a partner can make recommendations that could improve your formulation, pre-empt issues and help ensure ready integration with your processes.  

Drive operational excellence and continuous improvement

Outsourcing buffer preparation can also provide the opportunity to implement new technologies and approaches to stay at the forefront of the industry. The benefits from outsourcing buffer preparation can play an important part of driving efficiency and continuous improvement efforts for an organisation. 

 

Do the economics make sense? 

 
When you’re prioritizing the assignment of finite capital investment funds, outsourcing non-core functions is an obvious option. For outsourcing large volume liquids, specifically buffers, basing this important decision on data is vital, since there is often more than one option that can deliver measurable benefits.  

Understanding your current costs is a key first step, and an economic modeling tool is a good way to define these by quantifying the trade-offs and helping identify the potential benefits that can be achieved. By inputting data unique to your facility (such as detailed utility spend, labour costs, equipment, building cost, and buffer ingredients) it is possible to calculate a breakdown of annual expenses related to buffer production, and to determine a cost per litre. The analysis will facilitate informed outsourcing decision making.

As well as directly comparing overall costs, the cost-efficiency of individual steps should also be considered. For example, buying pre-weighed components can remove the time and effort needed to dispense and weigh the required raw materials, as well as reduce any requirements for special handling capabilities. 

Using the common buffer formulation of 0.1 M sodium hydroxide (NaOH) as an example, Fig. 1 shows how attractive the economics of outsourcing can be, simply based on the larger batch sizes achievable through the use of an outsource partner. The five-fold increase in lot size compared to the typical lot size in-house translates into significant annual savings, as well as reductions in prep time, lot testing, and per-litre cost. 

Even for organizations who produce large volumes in-house, facility redesign and new facility future-proofing can often tip the balance in favour of an outsource option. A new facility, or switching to single-use, can be an excellent opportunity to increase productivity per square meter by outsourcing non-core elements like buffer production.

  

Can you afford not to outsource?

 
Once you’ve made the decision to outsource, the key to making it a success is to choose an outsource partner that can accommodate your needs, whether you’re looking for flexibility of buffer packaging or format, proximity to your facility, manufacture in a cGMP environment, or simple cost savings. 

Getting it right from the start is vital; invest time upfront to ensure that priorities are clear and the production needs can be met. Evaluating options, such as powder or liquid formats and types of containers, can be daunting; however, the resulting product should be easy to use and fit right in to your existing process. 

Working closely together will result in the identification of a tailored solution — it’s about finding a solution that’s fit-for-purpose and cost-effective. With the compelling economics, outsourcing is implemented by more organizations every year. And ultimately, it could be more of a risk to continue doing business as usual, rather than to outsource.

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