White Paper –
Why Outsource Liquid Solutions? A Case for a Rapid and More Flexible Approach to Manufacturing

Liquid reagents are growing in importance within bioproduction process development, both upstream and downstream. Market research shows that an increasing number of biologics manufacturers are outsourcing more liquid reagents for their processes, thus avoiding the added responsibility of hydrating powder and filtering the solution. Historically, bioprocessors transitioned from liquid to powder formats during Phase II/III, primarily to save money and reduce the storage space required. This is now changing, as there is a tendency to remain in liquids longer through the clinical process, as well as to keep certain solutions, like feeds, additives and supplements, in a liquid format right through to commercialization.

When contemplating whether it is best to stay with a liquid or transition to powder, the process has to be closely studied. While liquids are not always the best route, in many cases they can be the best method. They can cut down on other incidental process steps, reduce potentially hazardous exposure, and generally make the process simpler and more flexible. In the right application, outsourcing liquid solutions can provide a leaner and more flexible approach to manufacturing.

In the past few years, SAFC has had a steady increase in the number of enquiries and projects involving liquid solutions. As a result, the company has established a formal growth strategy to help enable the growth of the liquid market, and ensure the products can meet customers’ demands moving forward. Extensive market research has been carried out to understand which products and skill sets are most likely to be in demand.

Greater Simplicity

One of the main advantages of utilizing liquids is both speed and ease of use for the operator. Most traditional fed-batch processes require a base medium and feed, as well as five to 10 different supplement additions, providing extra nutrients or trace elements that enhance process efficiency or yield. The challenge with multiple additions in a bioreactor is the number of process steps required, and with each addition comes a risk of a sterility breach and inevitable waste.

As a result, compounding certain additives together can result in a faster process, reduced waste and risk by simply reducing the number of additions into a bioreactor. This may sound simple, but it’s not – compounded solutions have to be developed and formulated in such a way that all components stay in solution for the correct period of time. This process often requires experience in concentrate development. Once a decision is made to pursue a compounding project, then a company has to determine how and by whom this will be accomplished. Outsourcing formulation development is one possible solution because it enables the manufacturer to focus their resources and core competence on primary objectives.

Greater Flexibility

Upstream and downstream liquid formats are, in many cases, the norm until the volumes required become much larger in the later stages of clinical development. In Phase II/III trials, the process is typically reengineered to use powder formats, and although it requires new process parameters, it is often viewed as cheaper in the long run because there is no need to pay for and ship water when a WFI system is already on site. However, many companies realize that critical raw materials rarely present the largest opportunity for cost savings, as they typically represent only 3–5% of the total cost of drug production.

While in the past many facilities were designed to produce single biologics, this is costly in terms of equipment and resources, and they are now looking to make multiple biologics in the same facility. The challenges then become efficiency, and the ability to do more with the existing resources such as space, personnel, equipment and time. While it will most likely never be financially advantageous to outsource the very high volume reagents as liquids, there are definite cost advantages in outsourcing those required in smaller volumes.

Outsourcing frees up scientists and operators for other tasks. In low-cost countries this is less of an issue, but it is not very cost-effective for companies located in North America and much of Western Europe to pay highly qualified scientists to mix powder with water. Many companies are taking a fresh perspective to the total cost of ownership of each individual process in order to identify the largest opportunities for savings. This involves evaluating what and when to outsource, including liquid solutions.

Greater Security

The ready availability of disposable technology is also facilitating the growth of the liquid market. Modern disposable packaging and corresponding leachable/extractable data, stability data and shipping validation data have all advanced, allowing the end user to be much more certain that their contents are sterile, safe and accurately formulated. SAFC has a partnership with Sartorius Stedim, a world-leading supplier of disposable packaging, bioprocessing and filtration technology, and this allows the company to supply liquid reagents in the right format for its customers’ processes.

There are further benefits; for example, these formulations often include tricky or corrosive chemicals such as sodium hydroxide, and outsourcing allows the manufacturer to avoid the hazards of working with these substances.

There will always be a place for powder, especially in those bioprocesses requiring very large volumes. The key is finding the right balance, which comes from experience and having relationships with suppliers who understand how to deliver tailored solutions.

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