Search results for " techniques"
Article
Q&As with Industry Leaders
…p;
Eva Heldin, Section Manager of Antibody Application, R&D, Cytiva
Current Techniques and Challenges Presented in Scaling Between Bioreactors
Jeanne Linke Northrop, BioPharm I…
Article
Design of Experiments for Analytical Method Development and Validation
Quality risk management and statistical data analysis techniques should be used to examine the process of measurement and identify factors that may influence precision, accuracy, linearity, signal to …
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Bioprocessing Advances in Vaccine Manufacture
In the BioPlan study, vendors were asked if they provide sufficiently scalable single-use disposables and techniques. Overall, 53% of the industry considers scale to be a significant adoption restrict…
Article
Essentials in Establishing and Using Design Space
Design space is established through proper characterization techniques and is often an extrapolation of the response surface. Two-dimensional contour and three-dimensional surface plots are typically …
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
What this means is that there will, obviously, be extensive characterization of the biosimilar product using what the FDA refers to as state-of-the-art analytical techniques.” Levine adds that human c…
Article
PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Subsequent downstream purification has been accomplished using standard chromatographic techniques (36).
VIRAL VECTORS
Using viral vectors as BioTx for gene therapy offers many exciting oppor…
Article
Evaluating the Use of Continuous Chromatography
Advances in process analytical technologies and modeling techniques, however, may provide solutions to improving chromatography control for industrial-scale manufacturing (3). These advances offer opp…
Article
A Closer Look at Affinity Ligands
BioPharm: Why are affinity ligands preferred for biologics purification over other downstream purification techniques?
Elliot (BioCina): Affinity ligands can produce a very high purification facto…