Authors



Iain MacGilp

Latest:

Risk-Averse Fill/Finish Industry Embraces Change

Single-use technologies, modular systems, and robots are on the rise.


Martin Reid

Latest:

Risk-Averse Fill/Finish Industry Embraces Change

Single-use technologies, modular systems, and robots are on the rise.


Amy Thanavaro

Latest:

Rethinking Cleaning Validation for API Manufacturing

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.


Chris Edlin

Latest:

Rethinking Cleaning Validation for API Manufacturing

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.


Dijana Hadziselimovic

Latest:

Cleaning Chromatography Resin Residues from Surfaces

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.


Adeyinka Aina

Latest:

Rethinking Cleaning Validation for API Manufacturing

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.


Paul Lopolito

Latest:

Rethinking Cleaning Validation for API Manufacturing

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.


Chunfen Zhang

Latest:

Rethinking Cleaning Validation for API Manufacturing

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.



Martin Wisher

Latest:

Preventing Microbial Contamination of Viral Vaccines and Vectors

The risks of microbial contamination inherent in the production of viral vaccines and viral vectors used in biotherapeutic applications must be addressed.


Anissa Boumlic

Latest:

Preventing Microbial Contamination of Viral Vaccines and Vectors

The risks of microbial contamination inherent in the production of viral vaccines and viral vectors used in biotherapeutic applications must be addressed.


Damon Asher

Latest:

Preventing Microbial Contamination of Viral Vaccines and Vectors

The risks of microbial contamination inherent in the production of viral vaccines and viral vectors used in biotherapeutic applications must be addressed.


Priyabrata Pattnaik

Latest:

Preventing Microbial Contamination of Viral Vaccines and Vectors

The risks of microbial contamination inherent in the production of viral vaccines and viral vectors used in biotherapeutic applications must be addressed.


Steve Stein

Latest:

Viewpoint: The Driver of Drug Delivery

Advances in medicine and consumer electronics can enhance drug delivery and patient care.


Ralph D. Lindblad

Latest:

Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.


David B. Klug

Latest:

Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.


Phyllis Walsh

Latest:

Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.


Katherine L. Ulman

Latest:

Understanding Excipient Characteristics to Ensure Robust Continuous Manufacturing

Key information is needed for excipients and their potential impact on continuous manufacturing processes.





James O’Brien

Latest:

Planning a Successful MES Deployment

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.


Sunil Singh

Latest:

Hard Capsules as a Flexible Dosage Form

Innovations in hard-capsule technology enhance the flexibility that hard capsules can provide for dosage forms.


Ilesh Desai

Latest:

Hard Capsules as a Flexible Dosage Form

Innovations in hard-capsule technology enhance the flexibility that hard capsules can provide for dosage forms.


Sarah Pratt

Latest:

Process Development Best Practices for Topical Drug Products

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.


Christopher Harrison

Latest:

Process Development Best Practices for Topical Drug Products

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.


Schott

Latest:

Natural Superpowers? Supernatural Wide pH-Range!

SCHOTTs latest vial innovation, is the only barrier coating for high pH fillings with hydrophobic surface combining all advantages of the Type I middle borosilicate glass container and the well-known 1-layer PICVD coating of SCHOTT.


Binodh DeSilva

Latest:

AAPS Traces the Path to ICH M10

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.


Antonio Hernandez-Cardoso

Latest:

Standards-Setting Activities on Impurities

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.