Authors


Prasad Adusumilli, PhD

Latest:

Monitoring Blend Uniformity with Effusivity

By moving uniformity monitoring back to the blender phase, blend variations that result from factors such as particle distribution and environmental temperature and humidity can be identified early.


Ligi Mathews

Latest:

Monitoring Blend Uniformity with Effusivity

By moving uniformity monitoring back to the blender phase, blend variations that result from factors such as particle distribution and environmental temperature and humidity can be identified early.


Satish Dipali, PhD

Latest:

Monitoring Blend Uniformity with Effusivity

By moving uniformity monitoring back to the blender phase, blend variations that result from factors such as particle distribution and environmental temperature and humidity can be identified early.


K. Venugopal

Latest:

Alteration in Dissolution Characteristics of Gelatin-Containing Formulations: A Review of the Problem, Test Methods, and Solutions

Eventual change in the dissolution characteristics of some dosage forms, which is ascribed to cross-linking of gelatin, continues to present challenges to drug manufacturers. The authors discuss the causes, mechanisms, and solutions to the problem.


Stefanos Daskalakis, PhD

Latest:

Monitoring Blend Uniformity with Effusivity

By moving uniformity monitoring back to the blender phase, blend variations that result from factors such as particle distribution and environmental temperature and humidity can be identified early.


Stephen Stefanou

Latest:

Using Ion Mobility Spectrometry for Cleaning Verification in Pharmaceutical Manufacturing

This article discusses the use of ion mobility spectrometry as an alternative to high-performance liquid chromatography to reduce the amount of time spent on the cleaning verification process.


Matt Davis

Latest:

Using Ion Mobility Spectrometry for Cleaning Verification in Pharmaceutical Manufacturing

This article discusses the use of ion mobility spectrometry as an alternative to high-performance liquid chromatography to reduce the amount of time spent on the cleaning verification process.


Gaurav Walia

Latest:

Using Ion Mobility Spectrometry for Cleaning Verification in Pharmaceutical Manufacturing

This article discusses the use of ion mobility spectrometry as an alternative to high-performance liquid chromatography to reduce the amount of time spent on the cleaning verification process.


Sai V. Nudurupati

Latest:

Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.


Michael J. Kukulka

Latest:

Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.


Takako Ono

Latest:

Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.


Haiyan Grady

Latest:

Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.


Claire Hill

Latest:

Using Lab Informatics and Instrumentation to Optimize Upstream Bioprocessing

Advanced technologies, such as artificial intelligence and synthetic biology, can be used to their full potential in upstream bioprocessing, provided that data and knowledge management can be effectively managed.


Dejan Djuric

Latest:

Obtaining User-Defined Particle Size Distribution Using Dry Granulation

The author examines the effect of compaction force, gap width, and sieve setup on granule size.


Amina Faham

Latest:

Paving the Way for Modernized Drug-Product Manufacturing Through Excipients

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.


True Rogers

Latest:

Paving the Way for Modernized Drug-Product Manufacturing Through Excipients

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.


Kathryn Hewlett

Latest:

Paving the Way for Modernized Drug-Product Manufacturing Through Excipients

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.


Jeff Pavlovich

Latest:

Classifying Potent and Highly Potent Molecules

Determining how much containment is needed for API handling requires evaluation of multiple factors.




Elke Hanke

Latest:

Ultrasonic calorimetry of membranes

Can high-resolution sound velocity measurements be used as an analytical tool?


Yan Wu

Latest:

Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template

A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.


Hanlin Li

Latest:

Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template

A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.


DIOSNA Dierks & Söhne GmbH

Latest:

CCS 10-80 RC

The Granulating Line CCS 10-80 RC by DIOSNA, a granulation line for pilot scale with a highly flexible range of batch sizes.


Baerbel Hinneburg, PhD

Latest:

How to Address Roadblocks During Technology Transfer: A CDMO’s Perspective

Real-life examples illustrate how to reduce the risks for each transferring partner and ensure that the development process meets regulatory requirements.


Michael Austin Roberts

Latest:

Are we moving towards global patenting?

Patents are an important tool for protecting innovative products, uses or processes intended for commercialization.


Mark Witcher

Latest:

Improving Prospective Product Development Methods Derived from Management-Based Regulatory Guidelines

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.


Harry Silver

Latest:

Multi-Purpose Biopharmaceutical Manufacturing Facilities Part II: Large-Scale Production

A matrix of multi-functional cleanrooms can be adapted for launching products.


Joanne Ratcliff, PhD

Latest:

Overcoming the Challenges of Capsule Filling in Preclinical and Clinical Studies

The authors discuss the challenges of capsule filling in preclinical and clinical studies.