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How New Technologies Can Improve Compliance in Pharmaceutical and Biotech Manufacturing

While U.S. drug products are of high quality, there has been an increasing trend towards manufacturing problems, resulting in recalls, disruption of operations and drug shortages. Companies are missing billions of dollars of potential additional revenue, and necessary medications are sometimes unavailable to the public. By enforcing 21 CFR Part 11 and introducing additional new quality-related initiatives, the FDA is signaling a need for better compliance to ensure consistency and safety. The industry wants to comply, but many manufacturers lack the necessary capabilities, or are unaware that new technologies are available to meet the beefed-up regulatory demands and still operate efficiently and profitably. Justin Neway, Ph.D., executive vice president and chief science officer of Aegis Analytical Corporation examines why these problems occur and how new technology can improve the manufacturing process.

Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT

Process improvement and Quality by Design become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time instead on productive science-based collaboration. This is the best way to undertake the Design Space Development, Design for Manufacturing and PAT efforts needed to achieve manufacturing process excellence using the principles of Quality by Design.

Final Bulk Inspection of Solid-Dose Pharmaceuticals

Inspect one million tablets or softgel capsules every hour. Compared to common inspection practices, new optical inspection systems offer lowered labor costs, faster changeovers, greater yield, reduced capital costs and simplified operation. Learn how to select a system that consistently delivers high quality product.

Development and Application of a New High Performance Mass Spectrometer for Small Molecule and Biotheraputic Pharmaceutical Development Applications

As scientists in Pharmaceutical and Analytical Development groups are called upon to identify an ever varying and always increasing number of APIs and unknown or unexpected impurities, many researchers are looking for more high performance analytical tools to better deal with these complex problems. Many groups rely upon traditional HPLC detection methods for much of their work, with a Mass Spectrometer available to aid in accurate mass determinations of unknown degradants or impurities routinely found in drug substances and drug products during routine development operations. However, the latest generation of more complex and larger molecular weight therapeutics and biotherapeutics has greatly complicated the analytical challenges in developing these types of molecules and the methods and analytical tools of the past are becoming increasingly less well suited for efficient and effective use.