Search results for " pharmaceutical" in Articles / App Notes
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Automating the Biomanufacturing Process
As robotic systems become more accessible and less expensive, Lebl sees them playing a bigger role in pharmaceutical manufacturing, especially for material movement.
Besides data storage, analytic…
Article
Biomanufacturing: The Cost of Unskilled Workers
First, a 2018 report from BioPlan Associates estimates there are well over 10,000 therapeutics in R&D, both drugs (chemical substance pharmaceuticals) and biopharmaceuticals (biotechnology-derived pha…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Remove or inactivate viral contaminants downstream
Regulatory bodies require that the purification process for a biological pharmaceutical removes any nonproduct virus. These “viral clearance” or …
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
Handling sterile liquids in the pharmaceutical industry has traditionally relied on consistent techniques over the past 100 years, and changes in technology and regulations have been relatively slow, …
Article
CDMOs Driving Emerging Bio/Pharma Success
CDMOs Driving Emerging Bio/Pharma Success
CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
By Jim Miller
Emerging bio/pharmaceutical companie…
Article
Applying GMPs in Stages of Development
In today’s pharmaceutical environment, it is not uncommon for more than one company to be involved in the development of a product. Virtual companies may use the services of a contract laboratory, a c…
Article
Navigating Data Integrity in the Modern Lab
Navigating Data Integrity in the Modern Lab
The importance of both technology and people in the modern laboratory.
By Amber Lowry
Understand…
Article
What's in Your SOP?
Whether you work in the medical device, pharmaceutical, or bio-technology industry, you are relying on SOPs to help you perform the day-to-day activities associated with your job. The purpose of an SO…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
This article discusses efforts that have been underway at Janssen Pharmaceuticals for the past few years to help achieve these goals. Corporate leaders wished to create a program with a transparent st…