Best Practices In Biomanufacturing Supplier Relations: Reducing Raw Materials Risks
Quality management is a matter of increasing importance to the biopharmaceutical manufacturing industry. In recent years, facilities have been gravitating toward quality-related analytical programs, and our data tells us they are also getting tougher on suppliers.
WHITE PAPERS & CASE STUDIES
A QbD Approach To Freeze Drying Of Cytotoxic Compounds
Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced. By Dr Kevin Ward
Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods
Multivariate Statistical Process Monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment. By Dr Frank Westad, Chief Scientific Officer, CAMO Software
Raising Expectations Of Excipients
An excipient’s role has traditionally been viewed as merely a filler or binder contributing to the stability of the end product. The full value that a formulation can bring to a final dosage form; or the real importance of ensuring an excipient’s quality and performance; are often underestimated, overlooked, misunderstood, or disregarded. In reality, the functionality of the excipient can help determine whether or not a drug succeeds or fails. By Fred Monsuur, Julia Poncher W. R. Grace & Co
QbD’s Role in Pharmaceutical Solid Dose Dry Granulation
The Pharmaceutical industry is undergoing change. Under fire by political pressures to drive down the cost per tablet, compounded by new drug discovery becoming more challenging escalating research costs, therefore, the industry is looking to unleash its efficiency shackles of the past.
Multivariate Data Analysis For Biopharmaceutical And Biotechnology
The modern biopharmaceutical/biotechnology manufacturing facility contains many sophisticated control, data logging, and data archiving systems. Massive amounts of data are collected from sources such as raw materials analysis, process outputs, and final quality assessments, which are stored in data warehouses.
Detecting Integrity Breaches In A Range Of Pharmaceutical Blister Package Types
Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. By Dr. D. Dixon, University of Ulster