By Maik Jornitz, COO, G-Con
Reducing the cost of goods sold has become a focus of pharmaceutical facility, cleanroom, and process design, especially as blockbuster patents have begun to expire and generic competition has intensified. The need to minimize manufacturing costs sparked a multitude of creative ideas.
By Bruce Rehlaender, Ph.D., Principal, Formulation Development, PharmaDirections, Inc.
If there were a bar where all of the hip drug product formulators hung out at the end of a hard day of formulating, two things would be certain: the beers on tap would be from breweries like Avery, Greenflash, and Dogfish Head, rather than Coors, Miller, and Anheuser Busch, and all of the jokes would be about discovery guys.
By Dr. Claire Freeman and Chris Freeman, Brookfield Engineering Laboratories, Inc.
Extensive research has brought about multiple ways of administering drugs, and, therefore, providing options to suit everyone. One of the most popular ways of administering drugs is in the form of gelatin capsules. Gelatin capsules have several advantages over conventional tablets, as they are softer, making them easier to swallow, and they mask unpleasant tastes and smells of the contents when swallowing, therefore promoting compliance. Gelatin capsules, being largely protein, are also readily soluble at body temperature and easily broken down by the digestive system, easing the absorption of the drug into the body.
By Christine Banaszek, Charles Ross and Son Company
Planetary mixers are ideal for wet granulation processes. Advantages include "one-pot" processing, high uniformity and yield, predictable performance, and ease of cleaning.
By Laura Studwell, Loma Systems
Prices for pharmaceutical products have been increasing at an accelerated rate for more than a decade. The increases are being driven by increased product competition, coupled with the growing cost of research and development, the increase in patent laws, and greater government legislation, as well as the price transparency created by insurance companies worldwide.
By Ed Emerson, MOCON, Inc.
In a world full of hungry microorganisms, it is critical that medical devices, designed to heal, do not inadvertently do the opposite by infecting the patient. To prevent infection, a device's packaging or "sterile barrier system" must maintain sterility during the product's entire shelf life.
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
When it comes to equipment manufacturing in the pharmaceutical industry, it is imperative that a product functions exactly as it was intended. Any misstep caused by faulty equipment could have catastrophic results for the company that produces a drug, but more importantly, for the patient who uses it. The serious consequences that can result from a lack of accurate equipment design and the associated manufacturing processes are why Donald Dobert, president and COO of ATL Pharmaceutical/Medical, created his company’s New Product Development (NPD) Planning Process.
By Randy Anderson, Catherine Morrow, and Christopher Perkins, PPD, Inc.
This paper summarizes precedent hyperglycemia rescue criteria, describes the necessary and sufficient conditions required to minimize the biasing effects of rescue on efficacy and safety assessments, discusses the clinical implementation and implications of these criteria, and details exactly how hyperglycemia-related discontinuations can impact clinical trial outcomes.
By Gary Roepke and Bob Applequist, Labconco Corporation
A glovebox is a sealed enclosure that allows materials handling through long, relatively impermeable gloves secured to ports in the walls of the enclosure. The purpose is protection or isolation, which is provided by the physical barrier. Depending on the type of system, the physical barrier may be to isolate a sensitive material inside the box from environmental contamination (controlled atmosphere type), or, to protect the operator from hazardous materials being manipulated inside the box (ventilated type). Most systems have a main chamber, where manipulations occur, and a smaller transfer, or antechamber, where samples, small apparatus, and supplies are introduced into the main chamber.
By Paul Dupont, Ropack
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater access to records, and conducting audits more frequently — up from .06 to .09 per year, according to Bloomberg News.