What are buffers?
Weak bases and their conjugate acids, or weak acids and their conjugate bases, are combined to create buffers. When compared to other constituents, the aqueous solutions of such mixtures are resistant to changes in pH, or acidity or basicity of a solution. Even when the hydronium [OH-] or hydrogen [H+] ions in a biological system fluctuate, biological buffers maintain the pH of the system at nearly constant levels. Protons are taken up by bases and released by acids. As a result, by absorbing and excreting excess protons and electrons, buffers maintain an almost constant pH throughout the solution.
In what ways do buffers find application in the biopharmaceutical sector?
The role of buffers in the processing of biologics both upstream and downstream
A variety of complex procedures are involved in the manufacturing of protein-based biologics for commercial application, and different buffers are needed to maintain pH stability and control different processes. Mostly used in upstream biologics processing, buffers such as HEPES help maintain the pH of culture media within a specific range and provide the right conditions for cell growth. Stabilized pH enhances the synthesis of desired proteins while maintaining the structural and functional integrity of the protein before downstream processes begin.
In order to maintain the ionization state of biological material and specific purification parameters for the best possible chromatographic purification, buffers are used in downstream biologics processing. Buffers are crucial for maintaining the structural and functional integrity of proteins under demanding downstream conditions. Buffers like TRIS, MES, Guanidine Hydrochloride, Ammonium Sulfate, and Citrate buffers are commonly used in GMP grades in the downstream biologics processing industry.
What buffers do for biologics formulations
Buffers are as important in manufacturing processes as they are in formulations. The final formulation of a biologic drug must maintain the required pH range in order for it to remain stable under various storage conditions for the duration of its clinical or commercial shelf life. In order to stabilize the final formulation and achieve the desired buffering range, careful ingredient selection is necessary during the buffer manufacturing process for finished products. Due to their direct contact with the therapeutic agents during the biologic formulation manufacturing process, GMP grade buffers are crucial to ensuring the final formulation’s safety and efficacy. Phosphate and citrate buffers of GMP grade are among the buffers that are commonly used in formulations.
Why GMP grade buffers?
For buffer manufacturing to meet or surpass compendial purity standards, complete GMP compliance is required. Complex biologics manufacturing companies in the biopharmaceutical industry highly value GMP grade buffer manufacturing. Compendial testing compliance, traceability, consistency, and transparency in the supply chain, as well as adherence to GDP and GMP practices as outlined by compendia like USP, EP, BP, and JP, are all ensured by GMP grade buffer manufacturing. GMP buffer manufacturing is necessary for early-stage, late-stage, and commercial biologics products in order to meet the safety and efficacy standards demanded by the target markets for which the products are developed and produced. Additionally, GMP grade buffers are frequently used in the production of innovative gene therapy and as vaccine excipients.
Why is custom GMP buffer manufacturing required?
Every biological process needs a specific pH tolerance range, and making custom GMP buffers is essential to achieving this. While some standard buffer solutions with MES, TRIS, HEPES, and phosphates can be utilized, it is advised to use custom GMP buffer manufacturing, particularly when creating innovative formulations and processes.
The needs for process-specific buffers with a defined pH range produced under complete GMP compliance are met by custom GMP buffer manufacturing. Compendial-compliant buffer manufacturing is crucial for the creation and production of innovative medicines.
Why is GMP buffer manufacturing outsourced?
As mentioned on our dedicated buffer manufacturing page, GMP grade buffer manufacturing requires dedicated equipment, personnel and facilities, preferably in close proximity to the end user to control transportation and regulatory costs. These factors make it necessary to outsource the production of GMP buffers since it frequently results in supply delays and bottlenecks at the end user’s manufacturing facility. A&C offers flexible, affordable, and customized solutions for your cleaning solution and buffer outsourcing needs, including localized manufacturing and availability of safety stock. Our GMP manufacturing plants are ISO 9001:2015 certified and our buffers can be manufactured with WFI (Water for Injection) or USP water.
Glossary:
GMP – Good Manufacturing Practice
TRIS – Tromethamine Hydrochloride
MES – 4-Morpholineethanesulfonic acid monohydrate
HEPES – 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid
USP – United States Pharmacopeia
EP – European Pharmacopoeia
BP – British Pharmacopoeia
JP – Japanese Pharmacopoeia
