Search results for "continuous"
Article
CDMOs Driving Emerging Bio/Pharma Success
This continuous funding streak is nearly twice as long as is typical for emerging bio/pharma companies.
A number of factors have contributed to the explosion in funding for emerging bio/pharma …
Article
CoAs Help Secure the Supply Chain
CoAs Help Secure the Supply Chain
Certificates of analysis can be used to monitor the reliability of products and their suppliers.
By Susan J. Schniepp, distinguished fellow at…
Article
Full Single-Use Downstream Process? Not Any Time Soon.
Single-use technologies (SUTs) are here to stay. But where we see full single-use upstream processes, downstream is often a hybrid solution. Here’s why SUTs will not completely replace reuse systems…
Article
Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
By Feliza Mirasol
zli…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Resource
CCP Summit
Three-day summit on commercializing continuous processing in pharma. Jan 30-Feb 1, Boston, MA
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
…
Article
Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
Article
Contract Manufacturing Through the Years
Developments in manufacturing technologies such as vastly improved yields for biologics, single-use systems, and continuous processing simultaneously require CDMOs to invest in new technologies while …
Article
Managing Risk in Biomanufacturing
With patients’ lives dependent on a continuous supply of high-quality drugs and vaccines, it is essential to have consistency within the industry on how to manage risks. Today’s business environment r…