Biosimilar Developments
Online trade publication covering technical, regulatory, and operational topics in biosimilar and biologics development. Publishes news, guest columns, white papers, case studies, and solution-center content on cell line development, bioprocessing, analytical methods, regulatory guidance, quality systems, and digital/automation approaches for biopharma professionals.
Industries
Nr. of Employees
medium (51-250)
Biosimilar Developments
Erie, Pennsylvania, United States, North America
Products
White papers and solution center content
In-depth white papers, application notes, and solution-center collections on manufacturing, regulatory, and technical topics for biosimilar and biologics development.
Newsletter
Regular email newsletter summarizing recent articles, news, and featured content in biosimilar development.
White papers and solution center content
In-depth white papers, application notes, and solution-center collections on manufacturing, regulatory, and technical topics for biosimilar and biologics development.
Newsletter
Regular email newsletter summarizing recent articles, news, and featured content in biosimilar development.
Services
Ongoing coverage of industry news, regulatory analysis, guest columns, and technical case studies targeted at biosimilar and biologics professionals.
Ongoing coverage of industry news, regulatory analysis, guest columns, and technical case studies targeted at biosimilar and biologics professionals.
Expertise Areas
- Biosimilar manufacturing
- Cell line development and expression optimization
- Bioprocess development and scale-up
- Downstream processing and purification
Key Technologies
- High-throughput automated cell-line screening
- Transposase-mediated site-specific integration
- Single-use bioreactors (including fixed-bed systems)
- Tangential flow filtration (TFF) and single-pass TFF
News & Updates
Guest column describing a high-throughput automated stable cell line platform, case studies in mAb and multispecific expression, vector optimization, and engineered host cell lines to accelerate timelines.
Analysis and expert interview on FDA draft guidance shifting emphasis away from comparative efficacy studies toward analytical data, toxicity, and PK/PD in biosimilar review.
Coverage of research integrating single-pass tangential-flow filtration and countercurrent membrane purification to concentrate clarified harvests and reduce host-cell proteins and DNA while maintaining yield.
Summary of EMA draft guidance on quality aspects for bacteriophage therapy products, including characterization, manufacturing, seed-lot systems, and potency assays.
Industry guidance on using platform knowledge and risk-based prioritization to define efficient control strategies and process characterization for accelerated monoclonal antibody development.
Discussion of digitizing deviation management between sponsors and CMOs, benefits of transparency and speed, and practical recommendations for data models, formats, validation responsibilities, and controlled vocabularies.
Guest column describing a high-throughput automated stable cell line platform, case studies in mAb and multispecific expression, vector optimization, and engineered host cell lines to accelerate timelines.
Analysis and expert interview on FDA draft guidance shifting emphasis away from comparative efficacy studies toward analytical data, toxicity, and PK/PD in biosimilar review.
Coverage of research integrating single-pass tangential-flow filtration and countercurrent membrane purification to concentrate clarified harvests and reduce host-cell proteins and DNA while maintaining yield.
Summary of EMA draft guidance on quality aspects for bacteriophage therapy products, including characterization, manufacturing, seed-lot systems, and potency assays.
Industry guidance on using platform knowledge and risk-based prioritization to define efficient control strategies and process characterization for accelerated monoclonal antibody development.
Discussion of digitizing deviation management between sponsors and CMOs, benefits of transparency and speed, and practical recommendations for data models, formats, validation responsibilities, and controlled vocabularies.