Maik Jornitz, Magnus Stering
Sterilizing grade filtration has been reliably used for decades and increasingly so, as more medicinal products are large molecule based, which requires cold sterilization, i.e. filtration.
Current issues companies are dealing with include aging technology within their laboratories; managing and compiling data from individual or standalone systems into larger, enterprise systems and the level of IT support needed for laboratory-based environments.
Emily Newsom, Mark Moffat, Akosua Acheampong, Natasha Meredith, Sheng Zhang, Adekunle Onadipe
The cryopreservation process can be stressful to sensitive microorganisms, including clinical isolates and stressed, injured or damaged environmental isolates.
Eurofins Lancaster Laboratories provides comprehensive laboratory services for the world’s largest pharmaceutical and biopharmaceutical companies offering testing for all stages of the drug development process.
David K. Mroz, Sydney R. Kestle, Paula E. Miller
There are several reasons for and against listing in the Orange Book drug-delivery device patents integral to the administration of the drug, that do not otherwise claim the drug.
Hibreniguss Terefe, PhD
Hot melt extrusion (HME) is currently one of the cutting-edge solubility enhancement manufacturing technologies that pharmaceutical development scientists consider when formulating poorly-soluble drug substances.
David Elder, Ph.D., Patrick J. Crowley
Excipients are essential ingredients in medicinal products, facilitating manufacture, stability, absorption, administration and, in some cases, drug targeting.
Douglas B. Hausner, Rodolfo J Romañach
The recent 14th Annual IFPAC and INDUNIV Summer Summit held in San Juan, Puerto Rico included a number of presentations on continuous manufacturing, process analytical technology (PAT), and the application of near infrared and Raman spectroscopy in both small molecule and biopharmaceutical manufacturing scenarios.
John Lipari
Unlike conventional tablets or powder-filled capsules, LBDDS can present the drug compound in a solubilized state, eliminating dissolution rate limited absorption and improving bioavailability.
Robert Dream
The importance and value of modular continuous processing technologies to provide economic and sustainability advantages means that the industry is able to adapt more rapidly to changing market demands.
Cassandra Braxton, PhD
Viral safety and control is a vital part of ensuring the safety of biological products in the biopharmaceutical industry.
Sarah Stowers, Archana Kumar, Ph.D.,, Diane Carrera, Chunang (Christine) Gu, Preeti Patel, Cadapakam Venkatramani, Dimitre Stoianov, Larry Wigman
This review focuses on the analytical challenges of chromatographically characterizing sulfonate salts/esters, hydrazine functionalities, amines, boronate esters/acids, aldehydes, and sulfonate acid/esters, and acyl (acid) halides used in the synthesis of pharmaceutical drug substances.
Christian Rack
Stability studies are a time consuming and resource intensive task in the development of new drugs. Therefore products are tested under accelerated conditions to increase the rate of chemical and/or physical degradation.
Mark C. Arjona, Michael Lau
Distek has developed a benchtop scale SUB system for mammalian cell growth and recombinant protein production.
Emilie Branch
Big Data has created a recent buzz in pharma. As information analytics permeates every aspect of a supply chain, the ability to harness, highlight and discern the most pressing information accessible has the potential to not only increase cost efficiency but also efficacy throughout.
Dr. Ronak Savla, Stephen Tindal
There are numerous tools and technologies for formulation scientists to develop the optimal dosage form for a
drug. As with many aspects of science, simply having the tools on hand is not enough. Experience plays a crucial
part in the development of a drug, interpretation of data, and application of knowledge appropriately to each
challenge that arises to ensure progress through developmental phases.
Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in April-June, 2017.