Outsourcing Buffer Preparation: A Cost Effective Approach for Biomanufacturers

Buffer preparation is one of the most crucial processes in the biopharmaceutical industry. However, buffer production is an expensive, time-consuming, and labor-intensive process that requires significant floor space and specialized equipment. Additionally, buffer storage during the large-scale production of biopharmaceuticals can be a challenge as buffer storage requires a large floor space at a time when emerging product classes are driving the need for multi-use, multi-scale manufacturing. To overcome the challenges associated with conventional buffer preparation / buffer manufacturing processes, pharmaceutical players are either installing novel buffer preparation systems in their manufacturing facilities or outsourcing buffer manufacturing needs to third party service providers. The global buffer preparation systems market is anticipated to grow at a CAGR of around 5.9%, till 2035. Driven by the growing demand for buffers and challenges associated with buffer manufacturing, the buffer preparation systems market is anticipated to witness steady growth in the coming decade.

Conventional Methods of Buffer Manufacturing

A buffer solution is a mixture of weak acids and their salts or a mixture of weak alkalis and their salts. The various steps involved in conventional buffer manufacturing process have been described below:

Novel Methods of Buffer Manufacturing

In order to address the aforementioned challenges associated with buffer preparation and buffer storage, several players have developed novel buffer preparation systems / in-line conditioning systems which enable simultaneous preparation of buffer from raw materials and their use in upstream and downstream applications. Integrated with automated technology platforms and sensors, such systems have allowed precise and controlled production of buffers in a timebound manner. It is worth highlighting that the use of novel buffer preparation systems / inline buffer conditioning systems has already demonstrated promising results in buffer manufacturing, in terms of process automation, time reduction and buffer quality. Various components of the novel buffer manufacturing systems have been explained below:

Advantages of Outsourcing Buffer Manufacturing

Given the technical and operational challenges associated with the production of buffers, innovators in the biopharmaceutical industry are increasingly relying on the contract service providers for their buffer manufacturing needs. Some of the primary advantages of outsourcing operations related to buffer manufacturing are briefly described below:

Key Considerations While Selecting An Outsourcing Partner

Buffer preparation is a multi-step process and selecting a suitable service provider for outsourcing different operations is one of the challenges for drug developers. Despite the several cost benefits and technical expertise, there are other parameters that need to be considered while selecting a service provider. Some of the key parameters that can be considered to assess the expertise and capabilities of third-party service providers have been briefly described below:

Future Perspectives

The growing demand for buffers and challenges associated with buffer manufacturing has prompted various pharmaceutical companies to leverage the expertise of players offering novel buffer manufacturing systems and related services. It is worth highlighting that novel buffer manufacturing systems are integrated with a wide range of features, including conductivity sensors, pressure sensors, temperature sensors, pH sensors and filters. Notably, a large number of buffer manufacturing systems have been developed to operate in an automated mode, reducing the risk of errors prone to human interface. In addition, over 20% of the buffer manufacturing systems offer preparation of both diluted and conditioned buffers, offering flexibility to users.  Driven by the growing demand for buffers, and ongoing efforts of buffer manufacturing service providers, the market is anticipated to witness steady growth in the coming decade.

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