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Ensure that all systems generating or storing manufacturing data are validated, secure, and audit trail enabled. Data used for release decisions or in...

Integrated monitoring systems, timely availability of process and quality data, and clear deviation management procedures. Advanced process monitoring...

Perform thorough process characterisation and define proven acceptable ranges for critical process parameters. Scale dependent effects such as mixing,...

Increasing emphasis on contamination control, especially for sterile products. Regulators expect a comprehensive strategy covering facility design, ut...

Maintain clear traceability between development knowledge, risk assessments, process decisions, and the control strategy. Regulators value structured ...

Establish a lifecycle management strategy early. Define which changes can be managed within the Pharmaceutical Quality System and which require regula...

Insufficient demonstration of process consistency and product comparability across development stages. Changes in cell line, scale, or process can aff...

Start with a structured Quality by Design approach. Define the Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), and...

Even though (CHO) protein databases are available, it is of added value to thoroughly analyse the pool of proteins expressed by the host cells used to...

The proteome protein databases can be downloaded from NCBI or Uniprot for all common expression systems. For GMP the database should be locked. Ejvi...

That depends on the situation, for example: what expression system are you using? How well is your process clearing residual host cell proteins, are t...

It is not needed to perform LC-MS-based HCP analysis in a GMP environment: in most cases, ELISA-based analysis works fine (and is accepted). The fact ...

In some cases it is an advantage to do GMP LC-MS analysis. E.g. when no suitable ELISA is available and it takes 2 years, a lot of money, and assay de...

Use best practice methods in USP 1132.1, and certified reference standards for calibration. Ejvind Mørtz, PhD, Co-Founder & COO of Alphalyse in ...

The proteome protein sequences can be downloaded from NCBI and Uniprot for all common expression systems, and most exotic expression systems as well. ...