Samantha N. Atkinson

Aug 15, 2024 | biosimilardevelopment.com | Yi Yang |Yadnyesh Patel |Samantha N. Atkinson

Get more biosimilar development insight with our FREE newsletter Newsletter | August 15, 2024 Derisking Biomanufacturing: Why A CDMO In Poland Might Be Your Secret WeaponAs the U.S. government works to pass the BIOSECURE Act, which aims to the protect the IP of U.S. pharma companies, the EU is simultaneously seeking to increase innovation across the European biomanufacturing industry.

Jul 30, 2024 | outsourcedpharma.com | Samantha N. Atkinson |Louis Garguilo

By Samantha Atkinson, executive vice president and principal consultant, NSF As human beings in a fast-moving world and professionals in an industry marked by continuous change and evolution, it is natural that we can sometimes be shortsighted in our vision and local in our thinking. While it is instinctive to care about what is happening around us, the value of understanding the wider implications of our actions often surpasses the learnings we can glean from a local or narrow view.

Feb 23, 2024 | pharmaceuticalonline.com | Samantha N. Atkinson |Eric Gudorf |Erika Morris

It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too. To GMP Or Not To GMP? That Is The (Plasmid) QuestionAs critical raw materials for viral vector production, plasmids are in high demand.

Feb 8, 2024 | outsourcedpharma.com | Samantha N. Atkinson |Louis Garguilo

Guest Column | February 8, 2024 By Samantha Atkinson, executive vice president and principal consultant, NSF It is well-known that regulatory authorities across the world are delving more deeply into the ongoing supply disruptions caused by quality system issues. These challenges must be resolved for businesses to thrive in compliance with the ever-changing regulatory landscape.

Feb 1, 2024 | pharmaceuticalonline.com | Samantha N. Atkinson |Claudia Müller |Heiko Nalenz |Roman Mathaes

Quality management maturity is an important new trend in the biopharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol. Supercharge Your Supply Chain: Harness AI To Gain Competitive AdvantageThe success of CGTs hinges upon adherence to specific logistics protocols.