Articles by Jerold Martin - BioPharm International

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Articles by Jerold Martin

A Brief History of Single-Use Manufacturing

Single-use manufacturing may seem like a new trend, but it has actually been around for almost 30 years, beginning in the early 1980s when filter manufacturers began to make small process-scale plastic filter capsules to replace "junior" size stainless-filter housing assemblies.
Nov 2, 2011

Single-use manufacturing may seem like a new trend, but it has actually been around for almost 30 years, beginning in the early 1980s when filter manufacturers began to make small process-scale plastic filter capsules to replace "junior" size stainless-filter housing assemblies.

Focus on Standardization, Quality by Design, and Regulatory GMP

In this quarter's column, highlights from the IBC Single-use Applications meeting, the PDA Single-use Workshop, and the BioProcess systems Alliance International Single-Use Summit are presented.
Nov 1, 2011

In this quarter's column, highlights from the IBC Single-use Applications meeting, the PDA Single-use Workshop, and the BioProcess systems Alliance International Single-Use Summit are presented.

Single-use Technology: Balancing the Risks and Rewards

Developing a quality agreement template for single-use systems.
Sep 2, 2011

Developing a quality agreement template for single-use systems.

Particulate Quality of Single-Use Filling Systems

The author looks at strategies to minimize particle levels in the finished product when using single-use technologies downstream of final capabilities.
Aug 1, 2011

The author looks at strategies to minimize particle levels in the finished product when using single-use technologies downstream of final capabilities.

Single-Use Technologies World Tour

Single-use conference roundup.
Jun 1, 2011

Single-use conference roundup.

Trends Toward Standardization

Although some aspects of single-use components can be standardized, it is unlikely that any materials or design features will become a commodity
Feb 1, 2011

Although some aspects of single-use components can be standardized, it is unlikely that any materials or design features will become a commodity

Regulatory Expectations and Consensus Industry Recommendations for Extractables Testing of Single-Use Process Equipment

BPSA eases confusion over extractables and leachables testing through guides.
Nov 2, 2010

BPSA eases confusion over extractables and leachables testing through guides.

Sterilizing Filtration of Adjuvanted Vaccines: Ensuring Successful Filter Qualification

Filterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.
Oct 2, 2010

Filterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.

Optimization, scale-up, and validation ISSUES in FILTRATION of Biopharmaceuticals, Part II

Sep 1, 2004

Filtration is one of the most commonly used unit operations in the manufacturing of biopharmaceuticals. This is the second part of the fourth article in the "Elements of Biopharmaceutical Production" series. In this second segment, Manoj Menon and Frank Riske present an approach for the development and optimization of a TFF application, followed by a contribution from Jennifer Campbell and Elizabeth Goodrich reviewing key issues involved in validation of a TFF step.

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