Edward S. Price
As every Contract Manufacturing Organization (CMO) knows, sourcing raw materials is critical to drug development and can make or break the chances for successful commercialization. Whether the project requires off-the-shelf or customized ingredients, cultivating sound, trustworthy and reliable supplier relationships significantly increases the chances of minimizing impurities and meeting project timelines.
Peter Wunderli, Ph.D., Jon Denissen, PhD, Maggie Bach, Moira Elmore, PhD, Erica Golueke
PPD’s QC bioassay laboratories in Middleton, Wisconsin, U.S., and Athlone, Ireland, previously reported observations regarding contamination control (CC) and environmental monitoring (EM) made over time and across program changes (Pharmaceutical Outsourcing, March/April 2016).
Mihaela Simianu
Pressure and scrutiny from regulators, customers, and stakeholders continue to drive the pharmaceutical industry to search for alternate ways to produce quality medicines at reasonable cost.
Sharon Wyatt Moore, MD, MBA, MPH, Andrew Kilpatrick, PhD
Pharmaceutical drug development occurs in one of the most dynamic environments - an environment that is always seeking new and innovative methods to increase efficiency and reduce timelines while improving patient safety, ensuring data integrity and complying with all regulatory requirements.
What are some of the current critical issues
facing the industry in regards to oral solid
dosage manufacturing?
Dr. Hildegard Bruemmer
Stability testing demonstrates how the quality of a drug substance or
drug product may be influenced by temperature, light, humidity and other
environmental factors, and is used to show shelf life within recommended
storage conditions. Studies to evaluate any physical, chemical, biological,
and microbiological attributes that may change during storage can be
complex and costly.
Vicky Qing Xia, Ronald A. Rader
Recent growth in the biopharmaceutical industry in both China, and India suggest a future positive outlook for contract manufacturing in both regions.
Nigel Walker
A patient recently diagnosed with a chronic illness is prescribed a
medication. The physician trusts this drug and, as a result, the patient
assumes that it will help him/her manage the condition. Though neither
party may give much thought to how the medication was produced or
how it made its way to the pharmacy, odds are it changed hands several
times. How can the patient be sure the medication he/she is going to
take is exactly what the doctor ordered?
International Pharmaceutical Expo (INTERPHEX), the premier event
dedicated to pharmaceutical and biotechnology innovation, technology
and knowledge from development through commercialization, and
sponsored by the Parenteral Drug Association (PDA), today announced
once again INTERPHEX has proven to be the place to “Learn It, Experience
It, Procure It” aggregating more than 7400 key decision makers sourcing
solutions. This year’s exhibit hall featured 635 leading suppliers, a cuttingedge,
no-cost technical conference, a two-day keynote series, a three-day
INTERPHEX Live program, and an Exhibitor Awards program.
Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) approved in the September-October 2016 timeframe. FDA approved 20 NDAs in these two months.