Rene Holm, Ph.D., H. Lundbeck
A large proportion of new chemical entities (NCE) entering drug development possess insufficient aqueous solubility to allow sufficient and consistent absorption from conventional pharmaceutical formulation systems
Thomas Bocan, Ph.D.
Due to improvements in technology associated with high throughput screening, genomics, proteomics and metabolomics, and expansion of the drug-able space from small molecules to biologics, e.g., proteins, antibodies, siRNA, stem cells, a greater number of unprecedented,
Jeanne Moldenhauer
From the earliest days of microscopy, scientists have been describing those parameters that indicate viability of microorganisms. In the late 1600’s, van Leeuwenhoek indicated that cells were viable based upon the motility of the cells. Much of his research was based upon his studies using human semen. The specimens that had a tail and were moving were alive, while the non-moving specimens were designated as dead [1]. Other scientists have equated cellular viability with the ability for the microorganism to reproduce; that is if it grows it is viable
Yong Zhou, Ph.D., Rebecca LoBello, Ph.D., Chunsheng Cai, Ph.D., Nicole Crane, Ph.D., Faiza Poshni, William W. Porter III, Ph.D., Yanxi Tan Cain, Ph.D.
Drug polymorphism has been studied closely in pharmaceutical science because the API (pseudo) polymorphs can play a critical role in the drug absorption and bioavailability [1-3]. The creation of amorphous API during processing operations and/or conversion to amorphous API in the drug products could be problematic for drug development [4-5].
Lindsay Leveen
In my three previous essays on the use of single use systems in biopharmaceutical drug manufacturing, I provided my assessment of the value that these systems will bring in the production of bulk drug substance (DS) or active pharmaceutical ingredient (API).
Kiran P. Malik, Chinwe Duru, Mahammad Ahmed, Paul Matejtschuk
Biologicals cover a wide range of materials which are often labile in solution and require lyophilization to stabilize them. For instance Factor VIII activity begins to fall as soon as a sample of plasma is taken and whether a purified concentrate from plasma or a recombinant product of DNA technology is considered, both show loss of activity during processing and on storage and so one of the challenges of formulation is to stabilize the biological material for the shelf life of the product
Irwin B. Silverstein, Ph.D.
Training in Good Manufacturing Practices (GMPs) is a requirement for pharmaceutical manufacturers per 21CFR211.25(a), Personnel Qualifications. All site personnel are expected to attend training, including GMP, as it relates to their functions. Section 3.12 of the ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, also requires employee training in GMPs appropriate to their responsibility.
Linzhe Liu, Steve Martellucci, Kang Ping Xiao, Ph.D., Kenneth Day, Anthony Osei, Ph.D., Abbie Gentry, Ph.D.
Methanol-based solutions are commonly used as extraction or dissolving solvents in analytical and bioanalytical methods for the analysis of ibuprofen (IBU). However, the potential for the formation of IBU alkyl esters in these solutions has not been addressed in these applications. The recent disruption in the supply of acetonitrile (ACN) triggered the need to identify alternative solvents for IBU analysis in pharmaceutical dosage forms.
M. Ashraf-Khorassani, Ph.D., L.T. Taylor, D.R. Brannagan, J. Wang, Ph.D.
Supercritical fluid chromatography (SFC) with electron capture detection (ECD) was evaluated for use in determination of low levels of alkylating agents. Several alkylating agents, varying widely in chemical functionality, two sulfonates, two neutral nitrogen heterocycles, three organic amine salts, and five halocarbons were evaluated by packed column SFC for separation and detection with both pure CO2 and methanol-modified CO2.
Matt Santangelo, Brent Maranzano, Ken Norris, Tim McDermott
Near infrared spectroscopy (NIRS) is a rapid analytical technique that is capable of assessing uniformity of a blend in a non-destructive, non-invasive manner [1,2]. These attributes of NIRS make it an effective tool for on-line, at-line or off-line analysis of pharmaceutical products.
Jon V. Beaman, Ph.D.
From a pharmaceutical development point of view, stability studies are frequently on the critical path to starting patient studies and registration stability studies, as described in the International Conference on Harmonisation (ICH) guideline Q1A (R2), are commonly the activity on the critical path to regulatory filing and approval [1]. Stability studies are also a significant resource commitment in both pre and post-approval phases.
Rizwan Sharnez, Ph. D.
This series on cleaning describes a methodology for developing cleaning processes from a product life-cycle perspective. The first part describes how the principles of Quality by Design can be applied to cleaning characterization; the subsequent parts deal with cleaning validation and monitoring.