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Exploring Takeda's Template For Sustainable Steam Generation
Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.
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Transforming Computer System Validation In The Life Sciences Industry
Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.
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Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.
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A Sterilizing-Grade Membrane For Efficient Filtration Of Biologics
Higher flow rates and a smaller process footprint can create meaningful gains across sterile filtration steps. Explore the performance data and where efficiency improvements may be possible.
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An Open-Source Modeling Tool For Suspended Continuous Lyophilization
Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.
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A Scalable Analytical Method For Quality-Driven AAV Characterization
AEX-HPLC has emerged as a robust, GMP-compatible analytical method for accurately characterizing AAV capsid composition, enabling consistent assessment of empty, partial, and full capsids to support product quality, process development, and regulatory readiness.
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Step Into The Future Of Chromatography Automation
As downstream processing grows more connected and complex, chromatography remains a key automation challenge. See how greater flexibility and stronger control are shaping more practical workflows.
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Process Intensification Through Downstream Connectivity
See how downstream steps can be linked into a coordinated workflow, with practical insight into automation, equipment integration, and process control for building a more efficient strategy.
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Solving Glycoengineering Challenges Could Begin At The Cell Line
Researchers produced a panel of platform cell lines illustrating how glycoform selection can be made experimentally visible earlier in biologics development.
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What Biopharma Often Overlooks In A Scheduled Shutdown
Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.
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LNP-Mediated Cell Transfection In Bioreactors Across Workflows
Lipid nanoparticles are redefining immune cell engineering. Delve into new data that demonstrates the performance across multiple cell types and bioreactor systems, supporting their potential workflows.
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Towards A Universal LNP Platform For Multiplex Engineering
Multiplex engineering of T cells for solid tumors requires precise delivery. Emerging LNP approaches enable co-delivery of RNA and DNA, offering a safer, more scalable path beyond viral vectors.
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Extrahepatic Delivery Of mRNA-LNP To Spleen
In vivo CAR-T approaches aim to reprogram T cells directly in the body using targeted lipid nanoparticles. Improved delivery to immune organs highlights new potential for scalable cell therapies.
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mRNA LNPs Drive Safe, Effective Repeat Dosing In Disease Models
Well-designed lipid nanoparticles enable safe, efficient delivery. OVA-based models show how formulation choices shape efficacy, safety, and anti-tumor outcomes in melanoma research.
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Discover A System That Can Be Used With Various Cell Culture Media
Evolving CAR T cell therapies are raising the bar for manufacturing. Advances in cell expansion and the shift to serum-free media are redefining how scalable, future-ready processes are designed.
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
- Samsung Bioepis And Organon Broaden Biosimilar Access In Australia Through Expanded Commercialisation Agreement
- The Biosimilars Council And AAM Applauds House Introduction Of The Expedited Access To Biosimilars Act
- Formycon And OneSource Specialty Pharma Announce Strategic Manufacturing Partnership For Biosimilars
- First Patient Dosed In The U.S. For International Multi-Center Phase 1 Clinical Trial Of Henlius' Subcutaneous Daratumumab Biosimilar HLX15-SC
- Biocon Announces Publication Of Pivotal Clinical Data Supporting Effectiveness Of Yesafili, A Biosimilar To Eylea (Aflibercept)