How Reliable Is The Pharma Equipment You Buy?
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.
WHITE PAPERS & CASE STUDIES
Precise Cold-Chain Logistics Supports Global Study Of Heart Disease
The challenge involved the precise cold storage temperatures (between 2-8°C) required to assure the integrity of the strips during the transfer and storage of the product to various sites around the globe.
A 15 Minute Guide To Efficient And Compliant Management Of GMP Controlled Documents
Life Sciences quality and manufacturing organizations face three critical industry forces: increasingly stringent regulation; globalization; and virtualization of supply networks.
Process For Scale-Up Of Adherent Vero Cells From Static Cell Factories To Influenza Production
In cell culture-based vaccine production, scale-up of adherent cells is challenging. This study shows a process for scaling up adherent Vero cells from static cell factories to influenza production at 50 L scale using WAVE Bioreactor™ systems and ReadyToProcess single-use equipment.
What Is Temperature Mapping & What Will It Accomplish?
The FDA, Health Canada and other regulators are increasingly putting the pressure on drug manufacturers to be in compliance with GMP requirements for controlled temperature storage. By Jean Bédard, President and CEO, Infitrak
A Comparison Of Performance Using Three Bioreactor Systems
New Brunswick Scientific (NBS) has introduced a new benchtop cell culture bioreactor that combines the benefits of single-use technology with the trusted performance and true scalability of a stirred-tank design.
Maintain The Benefits Of Single-Use Technology With Cell Culture Processing
Historically, stirred-tank bioreactors have been the standard for culturing all types of submerged cultures including suspension and anchorage-dependent mammalian, insect, yeast, plant and microbial cultures. By Nick Kohlstrom, Joseph Capone, and Ma Sha, Eppendorf Inc.