Buffer preparation resources

Outsourcing is becoming increasingly popular in biomanufacturing. As a time-consuming and resource-hungry unit operation, buffer preparation is often one of the first elements targeted for consideration.

To get you thinking, here are just five reasons why it might be the right choice for you:

1. Increased process efficiencies
2. Reduced risk
3. Decreased operating costs
4. Improved quality
5. Free up staff time

Looking for more reasons to outsource? Here are another 5 that you might want to consider:

6. Improved compliance
7. Improved productivity
8. Free up valuable floorspace
9. Simplify scale-up
10. Overcome formulation challenges

Of course, even with all these potential benefits, the decision is not always clear-cut. In the end, it will be about balancing risk and reward, and finding an answer that’s fit-for-purpose and cost effective.

To expand your thinking further, read our whitepaper or speak to one of the team.

Whilst the popularity of outsourcing buffer preparation is increasing, it won’t always be the right choice. The opportunities offered by outsourcing are inevitably accompanied by some concerns. These may include:

1. Loss of flexibility

Can an outsource partner meet my needs? What if my requirements change, can they easily adapt?

2. Loss of control

What happens if something goes wrong? Who is making the decisions?

3. Quality: Expectation vs Reality

How do I know I’ll get what my process requires?

4. Lack of integration

Can an outsource partner’s approach seamlessly integrate with my own processes?

5. Cost

Is the greater upfront cost justified?

It’s important to ask the hard questions when considering outsourcing your buffer preparation. And there are many variables which will determine whether it is the right time and circumstances for you.

The good news is that most issues can be reduced or eliminated through thoughtful planning and close collaboration with your potential outsourcing partner.

To see what might work for you, read our whitepaper or speak to one of the team.

Intelligently deploying the human inputs into the design and maintenance of your bioprocess is essential, particularly when increasing cost pressures means limited availability of resources.

Freeing up the time of your highly trained staff by moving them away from labour-intensive process steps, could be just the boost you need. Enabling them to focus on applying their knowledge to devising novel processes could also help drive future efficiencies.

Let’s take buffer preparation. A relatively straightforward process?

Yes.

But you need to factor in:

• quality control
• filtering
• sterility testing
• equipment maintenance
• documentation…

The list goes on.

The training and expertise requirements are extensive and can be a drain on human resources. By outsourcing buffer preparation, you could not only see overall cost and space savings, but also free up valuable staff.

Now all you need to consider is where your team could be better deployed!

To explore the outsourcing option further, read our whitepaper or speak to one of the team.

The arrival of more complex biologics, such as antibody fragments, antibody drug conjugates (ADCs) and bispecifics, can increase the complexity of the biomanufacturing process requirements.

Some buffer formulations, for example, are more complex than others.

The need to handle caustic or toxic chemicals, or special production conditions such as cold processing to maintain stability, can cause challenges when it comes to preparation and storage.

These challenges can very quickly drive an escalation in production costs and it can be difficult to access all the necessary expertise to manage them with your inhouse team.

As a technical sounding board, a buffer outsourcing partner can recommend improvements to the formulation of your buffer, pre-empt issues, and help ensure ready integration with your processes.

To find out whether you can you afford not to outsource buffer preparation, read our whitepaper or speak to one of the team.

No choice comes without potential risk and it is up to you to decide which risks you are willing to take. But are all risks created equal?

When deciding whether to prepare buffer in-house or to outsource, you have an opportunity to balance risk with reward.

Your considerations might include:

Risks in preparing and storing buffer in-house

• Loss of investment and wastage – if the full amount of buffer cannot be used in time
• Safety concerns – due to additional caustic/toxic chemicals

Risks in outsourcing buffer preparation

• Loss of control means
  • Quality of buffer may deviate from what is expected or required
  • Having correct buffer where and when you need it is not guaranteed

There is, however, a key difference in how you assess these risks.

If you collaborate in the right way, you can mitigate or remove risks associated with outsourcing, while also removing risks associated with in-house preparation.

But removing the risks associated with in-house buffer preparation, without outsourcing, is not so simple.

To discover more about how the risks, and opportunities, associated with outsourcing buffer preparation stack up, read our whitepaper or speak to one of the team.

Traditionally, manufacturers of biologics have relied on in-house production of buffers. But an increasing trend has been emerging in the industry over the last six years: outsourcing.

Why buffers?

Managing the logistics and large number of components involved with buffer manufacturing and storage requires extensive amounts of time and labor, as well as facility space. This has led manufacturers to seek alternative options to in-house preparation.

This is particularly true in downstream processes, due to the sheer number and volume of buffers required for multiple purification steps.

But is it right for you?

It’s no coincidence that the cultural shift towards outsourcing buffer preparation has been so substantial. Outsourcing buffers can be a solution irrespective of organization size or existing in-house capacity.

The benefits of outsourcing are multifaceted and have been laid out in our whitepaper.
Alternatively you can speak to one of the team.

Yes, outsourcing buffer preparation is advantageous for large-scale operations, but it also has its place in smaller processes e.g. in research or cell and gene therapy applications.

Particularly with the rapid upturn in cell and gene therapy processes in development, it’s time you considered what you could gain from outsourcing buffer when your batch size is smaller:

• It keeps organisations capital-lean
• It enables companies to maximise their limited resources most effectively
• It lays the groundwork for easy scale-up
• It provides an assurance of supply

Now thinking about outsourcing your buffer preparation? To help navigate the decision-making process, read our whitepaper or speak to one of the team.

Perhaps the most well-recognised advantage of outsourcing buffer preparation is the extra facility capacity that is freed up as a result of removing your in-house capabilities.

Buffer preparation and storage for a standard monoclonal antibody bioprocess can require up to 30% of a facility’s floor space.

Outsourcing buffer preparation provides a simple solution to reclaim some or all this footprint, eliminating the need for mixing and storage tanks and the accompanying maintenance requirements.

Reducing your storage needs opens up the opportunity of repurposing facility usage and even expanding on your existing manufacturing capacity. Such flexibility supports growth through the added benefit of diminished upfront capital expenditure and operating costs.

What are you waiting for?

To discover more benefits to outsourcing buffers, including the economic benefits, read our whitepaper or speak to one of the team.

With a finite pool of investment capital available, outsourcing of noncore functions is likely to be top of your list to consider.

In the case of buffer production, understanding your cost-per-liter is an important first step in evaluating the economics of your manufacturing process and making an informed decision.

The use of economic modelling, inputted with data unique to your facility and manufacturing process, is a good way to accurately calculate your cost-per-liter. Cost parameters you may want to factor in, include:

• Utility spend
• Labour
• Equipment
• Building cost
• Buffer ingredients

Once annual costs and breakdowns have been calculated, the cost-efficiency of individual steps, and whether the use of pre-prepared materials or outsourcing options could improve production economics, can be considered.

To read more about calculating your cost-per-liter and to see an example cost analysis breakdown, read our whitepaper or speak to one of the team.