Search results for " scalable"
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Second, scalable fermentation and downstream processing procedures were developed for each enzyme. These processes avoided the direct use of animal-derived components. Additionally, multiple productio…
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
As biologic-based therapies continue to evolve, drug companies are demanding more scalable systems, faster changeover, and more flexibility.
Read more Q&As with Industry Leaders Here
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
FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
Article
Multidimensional Scale-Up of a Monoclonal Antibody Capture Step, Using ÄKTA™ pilot 600
Equivalent mAb recovery and purity was achieved between the larger and the smaller scales, showing a robust and scalable process.
Click here to view the application note.
Article
Platform Technologies Improve Protein Expression
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
By Cynthia A. Challener
Speed to market is essential in the biopharmaceutica…
Poster
Rapid Process Development of a CIEX Step for a Biosimilar
When establishing purification processes for a biosimilar molecule it is important to develop steps that are scalable, selective, and cost-effective.
A cation exchange (CIEX) chromatographic ste…
Article
Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Modeling and miniaturization were two key take-home messages from the 4th High Throughput Process Development (HTPD) conference organized in October 2017 in Toledo, Spain. The conference brought tog…
Article
Avoiding Investigational Failures and Discrepancies
Some robust customizable EQMS solutions even include functionality that automatically handles quality events in accordance with scalable preconfigurations and triggers CAPAs whenever established thres…
Article
The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
By Jennifer Markarian
…