-
![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Understanding Adeno-Associated Virus Vector Impurities")
Understanding Adeno-Associated Virus Vector ImpuritiesAAV vectors hold promise for gene therapy, but removing product-related impurities remains a challenge. Learn how cell line development and process optimization are advancing rAAV production.
-
![GettyImages-1590576166 cells, research, lab, assay]( "Cell Culture Media Demystified For Performance, Quality, And Innovation")
Cell Culture Media Demystified For Performance, Quality, And InnovationCell culture media isn’t one-size-fits-all. Learn how media composition, customization, and analytics can dramatically improve cell growth, productivity, and product quality for complex processes.
-
![Scientists working in lab-GettyImages-542935478]( "Cell Culture Media Mixing In A Benchtop Single-Use Mixer")
Cell Culture Media Mixing In A Benchtop Single-Use MixerExplore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.
-
![Assessing Particle Generation In A Single-Use Mixing System]( "Assessing Particle Generation In A Single-Use Mixing System")
Assessing Particle Generation In A Single-Use Mixing SystemExplore how particle levels remained stable during 24 hours of high-speed mixing, even under extreme temperatures, confirming a system’s suitability for final fill and other particulate-sensitive applications.
-
![Globe Direcrtion-GettyImages-483422997]( "Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs")
Guidelines For Defining A Control Strategy Framework For Accelerated mAb ProgramsThis article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process.
-
![Adeno-associated viruses AAV GettyImages-1322096218]( "Scale-Up Of A Transient rAAV Production Process")
Scale-Up Of A Transient rAAV Production ProcessScalable rAAV production is achievable with a transient cell line and optimized bioreactor setup, delivering high titers and reduced impurities, now validated at 200 L scale for commercial readiness.
-
![GettyImages-1807380795-analytics-cell-analysis-laboratory]( "Scale-Up Of An Adherent rAAV Production Process")
Scale-Up Of An Adherent rAAV Production ProcessFixed-bed bioreactors simplify the scale-up of viral vector production. Discover a system that bridges development and manufacturing with data confirming consistent performance across scales.
-
![GettyImages-1441343945-virus-viral-infection]( "A Simple Method For Cell Growth Media Preparation")
A Simple Method For Cell Growth Media PreparationExplore how powder media and sterile fluid handling can reduce contamination risk and improve efficiency in viral vector production, especially for HEK293-based AAV workflows.
-
![GettyImages-1691974990-exosome-3d-render-cell]( "Exosome Production From hMSC Using A Fixed-Bed Bioreactor")
Exosome Production From hMSC Using A Fixed-Bed BioreactorExplore a high-yield, scalable process for hMSC-derived exosome production using fixed-bed bioreactors, with strong performance in purity, recovery, and biological activity.
-
![Earth Diverse unity-GettyImages-2189085103]( "Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots")
Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation LotsThe terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.
-
![vaccine, disease prevention-GettyImages-1155084813]( "Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs")
Dual Membrane Preconditioning Can Improve Concentration, Cut HCPsResearch from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.
-
![Cell Culture Media Filtration]( "Cell Culture Media Filtration: Evaluating Cell Culture Performance")
Cell Culture Media Filtration: Evaluating Cell Culture PerformanceCell culture performance remained consistent across PES and PVDF filters, even under worst-case filtration conditions. Discover a practical framework for evaluating membrane impact on CHO cell growth.
-
![Scientist with tablet in laboratory-GettyImages-1470739489]( "New Guide Aims To Build Robust Framework For Digital Validation Tools")
New Guide Aims To Build Robust Framework For Digital Validation ToolsThe ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.
-
![Eurasia and africa digital display-GettyImages-1368021598]( "Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms")
Pfizer's Accord For A Healthier World Program Challenges Stability Study NormsThe company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.
-
![growing chart of medical pills-GettyImages-2159767302]( "The 9 Fastest-Growing Outsourcing Segments")
The 9 Fastest-Growing Outsourcing SegmentsCapacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.
ABOUT BIOSIMILAR MANUFACTURING
Biosimilars are considered to be low-cost substitutions for pricy, large-molecule biologics. However, biosimilars must meet the same quality, safety, and efficacy as their reference biologic. Manufacturing biosimilars requires a more complicated procedure than that of manufacturing small molecule generics. Companies manufacturing biosimilars are focused on creating a chemical structure that is as close as possible to that of the reference product. Failure rates and operational costs pose a challenge for those companies involved in manufacturing biosimilars compared to those manufacturing small molecule generics.
Small molecule generics are created using the same active pharmaceutical ingredient (API) and, therefore, are chemically identical to that of the originator medicine. The manufacturing process for small molecules comprises only one-fifth of the total in-process tests required to meet Good Manufacturing Practice compared to that of biologic medicines (50 vs. 250 in-process tests). In fact, the manufacturing process for a large molecule is so complex, it cannot be duplicated by two different manufacturers, as the cells used in biologic medicines are unique to the company manufacturing each biologic.
Manufacturing a biologic consists of genetically modifying a cell, which becomes the basis for a cell line used for the production of the necessary protein for the biologic medicine. The protein is then separated from the cells and purified. Biosimilars are created from small alterations to the manufacturing process which creates a molecule that is not identical but closely resembles the reference product. While the differences in the biosimilar molecule might be slight, these changes in the manufacturing process of a biosimilar can affect the efficacy and safety of a biosimilar compared to the reference biologic. Over the past decade, the manufacturing process for proteins has become more standardized and the required technology has become increasingly accessible, leading to reductions in biosimilars production costs. As a result, a greater number of companies have begun manufacturing biosimilars, while reference brand manufacturers are setting their sights on bolstering pipelines and manufacturing biobetters to maintain market share for their soon-to-be-off-patent reference products.
BIOSIMILAR DEVELOPMENT NEWS
- AEON Biopharma Announces Fundraise Totaling Up to ~$22M Through Private Placement And Proposed Exchange Of Daewoong Convertible Notes
- EirGenix Signed The Commercial Licensing Agreement For Its Second HER2 Biosimilar Asset EG1206A
- Sandoz Signs Global License Agreement To Commercialize Breast Cancer Biosimilar pertuzumab
- UK High Court Rules In Favor Of Alvotech Paving Way For Manufacture And Market Entry Of AVT06, Biosimilar To Eylea® (aflibercept)
- Samsung Bioepis Reaches Settlement Agreement For PYZCHIVA (ustekinumab) In Europe