Search results for " comparability"
Article
Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Mechanistic modeling is considered a part of smart process development, which is a collection of approaches to get better process outcomes and speed up process development.
This week, Bioproce…
Resource
Protein A Fiber Chromatography from Research to Scale-up and Manufacturing of Monoclonal Antibodies
The new Protein A fiber chromatography format allows for quick purification of many samples because of its short cycle times. This makes the pre-packed, small-scale Protein A fiber unit a versatile …
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
Article
Capto™ High Productivity Resins
Capto™ chromatography resins give you increased productivity compared with Sepharose™ resins, through high binding capacity and high flow rates.
Explore Capto™ resins now >>
Article
New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
Article
Using Software in Process Validation
Using Software in Process Validation
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
…
Article
Overcome Chromatography Challenges with Fiber Adsorbents
Bioprocessing evolution highlights the desire for new purification technologies that offer greater flexibility for use—from research and early process development through large-scale commercial prod…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
Fiber-Based Protein A Chromatography for HTPD
Developing a process or looking for a clone of interest often requires screening large numbers of samples. Many analyses require purified proteins, and often substantial hands-on time is required fo…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…