Search results for " media"
Article
Raw Material Variability
Raw materials have a wide definition: cell-culture media; excipients; chemical additives; detergents; manufacturing process agents, for example, anti-foam agents or even product contact materials like…
Article
Q&A with Industry Leaders: Rita Peters
One example is Cytiva’s acquisition of the HyClone line cell culture media, sera, and process liquids; Dharmacon RNAi gene modulation, products; and Sera-Mag magnetic beads. With the changes in compan…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
From expertly packing chromatography columns, to providing higher-quality liquid media and buffers at large-scale, suppliers with technical competence are taking on some of the industry’s most challen…
Article
Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development.
The adoption of single-use systems in biopharmaceutical production or…
Article
A Platform Approach for the Purification of Domain Antibodies (Dabs)
This Application note describes a three-step purification process of a domain antibody (Dab) expressed in the periplasm of E. coli. First, a capture step using Capto™ L was used to reduce E. coli host…
Article
Elucidating Biosimilars Characterization
…ing expression systems and differences regarding the manufacturing processes, be it cell lines used, media used, differences in downstream processing or processing between the innovator and the biosi…
Article
Regulatory Challenges in the QbD Paradigm
…es, if needed, or limited hold steps where appropriate
• Lifetime use studies for purification media (i.e., resins and membranes)
• Validation and verification of cleaning processes, especial…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The possibility to serially connect Capto Q and Capto Core 700 media columns allows for enhanced system utilization and a reduced overall process time.
Before the sterile filtration step, the vi…
Article
PDA's Technical Report for Biotech Cleaning Validation
TOC also measures other sources of organic carbon, including media, cellular materials, detergents, and organic process materials. If total protein is used as a nonspecific analytical method for the a…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
However, because of their large size, their binding capacity is usually very low and chromatographic media with normal pore sizes used for proteins offer no advantages since the pores are not availabl…