Authors



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.


Pauline M. Rudd

Latest:

Improvement of Structural Profiling of N-glycans in Biologics

A suitable tool for analyzing glycans in biopharmaceutical manufacturing is the growing use of analytical enzymes known as exoglycosidases.


Xiaofeng Shi

Latest:

Improvement of Structural Profiling of N-glycans in Biologics

A suitable tool for analyzing glycans in biopharmaceutical manufacturing is the growing use of analytical enzymes known as exoglycosidases.


Christopher H. Taron

Latest:

Improvement of Structural Profiling of N-glycans in Biologics

A suitable tool for analyzing glycans in biopharmaceutical manufacturing is the growing use of analytical enzymes known as exoglycosidases.


Ian Walsh

Latest:

Improvement of Structural Profiling of N-glycans in Biologics

A suitable tool for analyzing glycans in biopharmaceutical manufacturing is the growing use of analytical enzymes known as exoglycosidases.


Stan Altan

Latest:

Understanding Internal Release Limits

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.


Jeff Kenvin

Latest:

Using Nondestructive in-situ Measurements to Ensure Lyophilized Product Stability

Non-destructive surface area measurement can improve stability testing.


Mark Johnson

Latest:

Understanding Internal Release Limits

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.


Yilje Dong

Latest:

Understanding Internal Release Limits

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.


Stacy Sherling

Latest:

Understanding Internal Release Limits

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.