Authors


Genesis Packaging Technologies

Latest:

Developing a Method to Learn Capper Settings to Handle Component Variations   

One of the causes of crimp variation that can lead to integrity failures due to poorly sealed vials has been reported to be component dimensional variation. Critical dimensions of the components of a vial system (vial, stopper, and cap) can vary within manufacturing tolerances, but these ranges of variation may require adjustments to the capper settings to ensure a proper package seal.


Fernanda Onofre

Latest:

Polymer Influence on the Rheological Properties of Co-Processed Microcrystalline Cellulose and Sodium Carboxymethylcellulose

In this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.


Lisa Fink

Latest:

Collaborative Efforts Address Key Data Integrity Challenges

Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.


James Holman

Latest:

Optimizing Loss-in-Weight Feeding of Poorly Flowing Materials

Prior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.


Mamdouh Moustafa

Latest:

Formulation of Sustained-Release Ketorolac Tromethamine Pellets

The authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.


Mike Hennessy Jr.

Latest:

Driving Advancement Through Scientific and Operational Innovation

Scientific breakthroughs, operational innovation, and cultural shifts are driving tomorrow’s medicines.


Martins O. Emeje

Latest:

Evaluating Okra Gum in a Floating Tablet Formulation as a Novel Drug Delivery System

The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.


Juan Vargas

Latest:

Determining Water Content with a Novel Karl Fischer Titration Approach

A new approach to testing water content in biologics is needed that will give a more accurate determination of actual water content in the biologic.



Rajesh Parikh

Latest:

Formulation of Modified Liquid-Solid Compact for Dissolution Enhancement of Raloxifene Hydrochloride

The purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.


William F. Koch

Latest:

Inside USP: USP Metals Testing: A Workshop Report

Attendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.


Veronika Horková

Latest:

Rapid Sterility Methods for CAR T-cell Therapies

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.


Deborah Huck

Latest:

Characterizing A Nasal Spray Formulation From Droplet To API Particle Size

The way in which a suspension nasal spray product interacts with the body depends not only on the droplet size of the delivered droplet, but also on the particle size of the suspended API.


James Vesper

Latest:

A Four-Phased Approach for Evaluating a Quality Risk Management Activity

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.


Ashvin Patel

Latest:

IVPT Data Analysis with FDA Statistical Approach to Assess Bioequivalence

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.


Janeen Skutnik

Latest:

The Ideal Pharmacopeia

This position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.


Sandy Macrae

Latest:

Do emerging markets provide the answer to the pharmaceutical industry?

The emerging markets represent an attractive investment opportunity for the pharmaceutical industry because of the countries' growing economies and unmet medical needs.


Gayathri Acharya

Latest:

Digitalization of QbD Risk Assessments

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.


Albert Alexander

Latest:

Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive Powders

In this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.


Fergus Manford

Latest:

Integrated Approach Facilitates Inhalation Drug Development

The choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.


Joe Sheffer

Latest:

Considerations for Monoclonal Antibody Bioprocess and Manufacturing Validation

Regulatory, analytical, and process concerns must be taken into account.


Ranna Eardley-Patel

Latest:

Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine Manufacturing

This article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.


Gregor Awang

Latest:

High-Growth Microbial Fermentation for the Manufacture of Biologics

Challenges in fermentation can be addressed through equipment changes, facility design, and process development.



Janice M. Hogan

Latest:

Science, Empiricism, and Off-label Use

Was FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?



Charles Potter

Latest:

Needle-Free Injection

Needle-free injection technologies have been developed for injecting liquid formulations, as well as injecting drugs and vaccines in a solid dosage form.


Mohamed Etman

Latest:

Formulation of Sustained-Release Ketorolac Tromethamine Pellets

The authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.



Kindeva

Latest:

Microneedle Array Patch Innovations

Kindeva’s microneedle array patch platforms for solid and liquid APIs have the potential to deliver far-reaching clinical, environmental, and usability benefits.