Articles by Simon Chalk - BioPharm International

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Articles by Simon Chalk

Raw Material Variability

The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
Apr 1, 2014

The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.

Achieving Supply Chain Excellence in Single-Use Systems

Mar 1, 2014

For single-use systems, supply chain excellence requires a commitment to problem solving across organization boundaries.

Risk Aversion and Closed-System Processing

Closed-system processing becomes best practice … almost.
Nov 1, 2013

Using closed systems opens up many new possibilities for how facilities are designed and operated and may also present lower risk to the operation and, ultimately, the product.

Flexibility in Biopharmaceutical Manufacturing

Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
Jun 1, 2013

Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.

New Challenges to the Cleanroom Paradigm for Multi-Product Facilities

Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.
May 1, 2013

Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.

Benchmarking: Don't Just Run the Numbers, Understand the Process

Benchmarking can be a useful tool to improve manufacturing practices.
Apr 1, 2013

Benchmarking can be a useful tool to improve manufacturing practices.

Relevance Regained

Improvement strategy should be linked to business strategy.
Feb 1, 2013

Improvement strategy should be linked to business strategy.

The Transformation to Process-Centered Organization

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?
Nov 1, 2012

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

Streamlining Batch Record Review and Approval

A one-day sign off for batch records is considered a best practice in the industry.
Aug 1, 2012

A one-day sign off for batch records is considered a best practice in the industry.

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