Buffers play a vital role in the production of therapeutic drugs as they help to stabilize pH and maintain the stability of the product at the final stage. With increasing demand for target-specific therapeutic drugs, vaccines, and genetic therapies, biopharmaceutical companies have to emphasize buffer manufacturing along with other logistics. Managing drug development and components that involve buffer storage and manufacturing requires a huge amount of labor, time, and, most importantly, production units.
The bioproduction of buffer and storage may require half of the facility space that can be used for other manufacturing activities. There is a requirement for higher lean operations and higher titers, which can be a costly venture. By considering all challenges, biopharmaceutical companies are relying on third parties to outsource their buffer manufacturing. Outsourcing buffer manufacturing offers significant advantages including cost-cutting, technology support and on-time quality buffer solution delivery. With robust outsourcing support pharmaceutical companies can focus on designing potential therapeutic drugs rather than investing time in finding solutions for buffer manufacturing. The global buffer preparation market is anticipated to grow at a CAGR of around 5.9%, till 2035, according to Roots Analysis.
What Are Buffer Solutions?
Buffer refers to the acid and base aqueous solution that comprises a mixture of conjugate base and weak acid. The solutions can resist change in the pH value even when a small amount of base or acid is added to it. Ammonium acetate is an example of a buffer which is used to maintain the pH of the drugs during manufacturing. Buffers are helpful in maintaining pH value—ensuring the stability of the therapeutic drug components and protecting from degradation and changes that occur during drug manufacturing.
Common Challenges During Buffer Manufacturing
The biggest problem that occurs during buffering manufacturing is downstream processing, which requires volumes up to 10-20x equal to the volume of the bioreactors used during upstream processing. The production of buffers in-house, along with other drug manufacturing processes, require plenty of space, staff, and equipment to handle and prepare buffers. It also requires regulatory monitoring and quality management. Buffer preparation requires almost double facilities, which can be challenging to add to a specific drug manufacturing system. Other problems that arise during buffer manufacturing include:
▪ The cost of installation of a buffer manufacturing system is extremely high.
▪ Buffer storage requires precise temperature control and in-line conditioning systems, which add cost and consume space.
▪ Buffer final solutions require multiple purifications and consume a lot of time. For example, most biopharmaceutical industry players are developing higher titers for their drugs that can cause significant problems during the purification process and may require large volumes of buffers. The rising demand for buffers can create a bottleneck for the company’s in-house buffer manufacturing system.
▪ CGT (Competitive genetic therapies) production is a challenge as it may require a balance of multiple buffers that are incorporated within a single process. Pharmaceutical companies have to produce large amounts of buffers to meet the requirements of CGTs, and in-house buffer manufacturing is not sufficient to meet the demand.
Why Outsourcing is an Ideal Option for Buffer Manufacturing?
Outsourcing buffer manufacturing enables companies to invest their time in drug designing and utilize their limited resources positively. Such a paradigm shift to outsourcing helps to maximize productivity and lays an easy scale-up groundwork system to minimize the delay in the production of drugs and commercialization.
1. Outsourcing With Advance Technology Players Ensures Quality
Buffer solutions are the most crucial element in the production of biological therapeutics; thus, the quality of these solutions is of utmost importance. Outsourcing buffer manufacturing from reputable partners gives you surety of GMP-grade buffers that meet both upstream and downstream processes. As buffer manufacturing companies shifted to technology such as automated buffer management systems, therapeutic drug classes such as CGTs are becoming common. A trusted buffer manufacturing partner with all advanced technology and equipment provides you with testified buffer solutions that are needed for unique drug formulation.
For biopharmaceutical companies that emphasize the development of high protein-based therapeutic drugs, diverting their attention to optimizing dozens of buffer solutions may deflect them from the actual drug development mission. The problem can be solved with an outsourcing buffer manufacturing partner as they have technology support and deep expertise in the development of buffer formulations with all quality test validation documents required for production.
1. Increase Facility Footprint
Buffers hold the major part of therapeutic drug production, specifically for downstream processing by volume. The large amount of buffers requires enormous storage space that can be challenging to manage for pharmaceutical companies. For example, a large amount of facility footprint space is required to store 30,000 L of buffer solution, and most importantly, appropriate temperature maintenance is required in warehousing. Preparation and storage of buffers in in-house operational units poses a risk of wastage because buffers have a short lifespan and If it isn’t utilized on time, it becomes unviable.
Outsourcing is a simple solution to avoid the risk of wastage, eliminating the requirement of facility footprint space, mixing tanks, and maintenance and offering added benefits such as reduced operational cost.
2. Drive Continuous Improvement
Outsourcing buffer manufacturing provides you with an opportunity for continuous improvements with the latest technology and software solutions that help you stay at the forefront of the pharmaceutical industry. With outsourcing, companies can leverage a continuous supply of buffers with complete efficiency.
3. Better Insight About Pre-Empt Issues
Accessing the buffer manufacturing system from an outsourcing partner provides you with valuable insight and support. For instance, outsourcing buffer manufacturing helps to avoid the risk of exposure to unwanted leachables and extractables that degrade the quality of buffer solution. They also help to mitigate the pre-empt issues and offer complete integration of the process to provide quality solutions.
Recent News in the Buffer Manufacturing Market
Some of the recent news associated with outsourcing buffer manufacturing market includes:
▪ In August 2023, Asahi Kasei entered into a strategic partnership with GeminiBio for the advancements of their applications within in-line buffer formulation and to streamline the manufacturing process of biopharmaceuticals.
▪ In June 2023, Thermo Fisher Scientific announced the expansion of their biological manufacturing facility in Switzerland by including a separate large-scale buffer preparation area and large-scale media areas.
Key Players of the Buffer Manufacturing Market
Examples of the top buffer manufacturing system market are as follows:
▪ Asahi Kasei
▪ Pall Corporation
▪ Thermo Fisher Scientific
Overall, working with an outsourced buffer manufacturing partner saves time and investment and helps you receive quality solutions. With the outsourcing of services, companies have easily focused on finding new opportunities in drug development by avoiding the risk of wastage of buffer solutions due to short viability. Ultimately, with outsourcing of the buffers pharmaceutical companies can stay upfront in driving more therapeutic solutions into the market.
About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.