Search results for "concentration"
Article
The Importance of Partnering for Bioanalytical Studies
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Bose (Emery Pharma): Bioanalytical studies, which are designed to provide estimates for concentration of drugs and biologics in pre-clinical and clinic studies of the therapeutic molecule or t…
Article
Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…
Article
Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
This trend towards higher concentration is a challenge for existing filters due to the higher particulate load and viscosity. It is harder to process fluid through the filter and it clogs faster. Manu…
Article
Digitalization: The Route to Biopharma 4.0
For flow-through chromatography, plate model, mass balance model, and general rate model can be used to capture phases, generate breakthrough curves, and predict product concentrations. These models c…
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
An advantage of FBRs is that because cells are in higher concentration than in STR at seeding due to the lower volume of the vessel, less are needed for inoculation, which reduces the operational burd…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
MATERIALS AND METHODS
Monoclonal antibody (mAb-A, IgG1) formulation
The mAb-A formulation (64 mg/mL protein concentration) was prepared in a formulation that contained a buffering agent (10 mM…
Poster
Residual DNA analysis in influenza vaccine processing
Samples from the vaccine purification process contain different buffers, salts, and host cell compounds, and varies 3–4 logs in DNA concentration from harvest to the final product, which all put strai…
Article
Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…
Article
Improving PAT for Biologics
For biologics that are extracellular and present in relatively large concentrations, there is a good potential for direct detection through the use of spectroscopic measurement techniques. This type o…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
…able to accurately quantify examplain HCl drug substance over a range of 90% to 110% of the nominal concentration with accuracy and precision such that measurements fall within ±2.0% of the true valu…