08.07.14 -- What You Missed From The FDA Last Week; Novartis Vaccinates Over 45K People In Bexsero Campaign
Life Science Leader and BayBio bring you interactive panels on the challenges to managing outsourcing relationships. Panelists include Andy Skibo (RVP, AstraZeneca; EVP, MedImmune), David Lowndes (SVP, Shire), Bob Kanuga (VP, Merck), Junning Lee (SVP, Theravance Biopharma), Terry Novak (COO, Pernix Therapeutics), and others. Learn more.
By Wayne Koberstein, Executive Editor
Sometimes the smallest bits of evidence light up the largest theories. Like the infinitesimal traces of the Big Bang astronomers recently teased from cosmic background radiation — data showing the effects of gravitational waves in the universe at zero plus one-trillionth of a second — a single company case, stripped down to the bare essentials, can teach fundamental lessons about growth after start-up.
By Paul Dupont, Ropack, Inc.
Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17 percent of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook, compiled by GBI Research.
By Dr. Rüdiger Lomb, Global Director, Quality and Technical Compliance, World Courier
This article covers improving compliance and efficiency in the pharmaceutical supply chain with reduced cost and risk. How does the sponsor ensure that product transfer conforms to the same established written procedures demanded at the investigator level throughout the full length of the supply chain, or more specifically, while in the hands of non-pharmaceutical, non-investigator personnel?
By Chuck Reed, Weiler Engineering, Inc.
Maximized uptime, minimized changeover time, and efficient OEE are key factors that have influenced the acceptance of aseptic blow-fill-seal in the packaging of pharmaceutical liquids.
By Robert G. McGregor, General Manager, Brookfield Engineering Laboratories, Inc.
The pharmaceutical industry typically employs the grab-sample technique to evaluate viscosity behavior of material in process. High-volume products such as cough syrup and skin lotions for sun protection are good candidates for “in-process” viscosity measurement because payback for equipment investment can be justified. Products produced in limited quantity should continue with the grab-sample approach.
By Maik W. Jornitz, President, G-CON Manufacturing LLC
Past experiences have shown that too often product quality is based on sole reliance on vendor certifications, statements, and promises. To diminish such reliance, new technologies were implemented, such as process analytical technologies (PAT), process controls, automation, etc., often once again overexerted as the solution to all problems; activities that supposedly result in higher product quality due to better process controls.
October 27 to 29, 2014, The Ritz-Carlton, Laguna Niguel, CA
The #1 partnering event for the pharma and biotech industries.
Pharma/Biotechs: Get 25 percent off your registration with code BN14PHARMAO. Learn more.