August 5, 2024
Sponsored by Thermo Fisher Scientific
This comprehensive white paper, titled "Maximizing Scale Up: Critical Considerations for Buffer Preparation," provides an in-depth exploration of essential aspects of buffer preparation in biopharmaceutical manufacturing. Key topics include:
The complexities and criticality of buffer preparation in the context of advances in product offerings, bioprocessing materials, process technologies, and facility design.
The decision-making process between in-house and contracted buffer production, considering factors such as formulation, process design, material specification, and manufacturers' existing facilities and capabilities.
The paper also delves into the economic implications of these choices, presenting a case study that compares the costs of in-house and outsourced buffer preparation.
Additionally, it provides a detailed analysis of various buffer preparation methods, elucidating the advantages and disadvantages of each. Key considerations include:
The importance of quality and regulatory requirements in Good Manufacturing Practice (GMP) facilities.
The role of robust quality assurance and control procedures.
Finally, the white paper highlights the services offered by Thermo Fisher Scientific's Process Liquid Preparation Services. These services are designed to help biopharmaceutical companies:
Streamline processes.
Maintain regulatory compliance.
Deliver cGMP chemicals, process liquids, and buffers.
This paper serves as a valuable resource for those involved in biopharmaceutical manufacturing and buffer preparation.
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