How to reduce crosslinking and ensure fast dissolution in soft caps
Crosslinking is a natural phenomenon occurring in gelatin that negatively impacts soft capsules, reducing their stability and prolonging their dissolution time.
Delivery formulations
Pulmonary Delivery of Orally Inhaled Therapeutics
New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small molecules and systemic indications.
In Vivo Evaluation of a Gastro-Resistant HPMC-Based “Next Generation Enteric” Capsule
Invivo: Many orally dosed APIs are bioavailable only when formulated as an enteric dosage form to protect them from the harsh environment of the stomach. However, an enteric formulation is often accompanied with a higher development effort in the first...
ReciBioPharm - An optimized Plasmid DNA platform to accelerate the path to clinic and commercialization
Assessing key parameters of the upstream process to achieve high titer while maintaining desired integrity Customizing the downstream process to address the different needs from supercoil plasmid and linear isoform A platform approach with integrated...
A Better Approach, for Better Pain Trials
Pain studies face unique challenges. For one, pain severity can only be truly assessed by the patients themselves. The controlled substances that are often used as experimental treatments in these studies bring stricter drug accountability requirements....
Transforming Clinical Development
The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical, medical device and diagnostics manufactures to identify failures early, in order to minimize costs,...
Flow Cytometry Services
We are an established leader in flow cytometry services for clinical trials. Our technologies and solutions meet the growing global demand for enhanced discovery capabilities, and the subsequent complex and comprehensive data sets required for drug...
UPLC Analysis of Methoxy & 2-Hydroxypropoxy in Hypromellose
Because of its use in the pharmaceutical and food industries, the USP has established standards relating to the amount of methoxyl and 2-hydroxypropoxyl substitutions in hypromellose. The USP...
Article on Viral Clearance for Biopharmaceuticals
Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the...
Customized Biosimilarity Analytical Testing from Catalent
Assessment of biosimilar molecules requires an orthogonal analytical approach. Any one particular analytical technique is not able to fully define the physical and biological characteristics of...