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Manufacturing Challenges With High Concentration Biologics
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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2024 LIMS Trends
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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A New Model Approach To Drug Shortage Prevention
The ISPE's Drug Shortages Prevention Model revamps its predecessor, the more prescriptive Drug Shortages Prevention Plan, with a focus on 12 key performance areas.
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Doubling Down On Biopharma’s Growing Skills Drought
The biopharmaceutical industry is building manufacturing capacity at breakneck speed. According to PhRMA, there are 1,580-and-counting biopharma manufacturing facilities in the U.S. alone. Problem is, we're way short on filling those facilities with skilled labor. NIIMBL wants to change that. Here's how, and a great opportunity for big pharma, biotech sponsors, CDMOs, academics, and more to help.
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Sterilizing Grade Filter Performance With Biologic Drugs
Here, we analyze the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins and demonstrate how filter selection can impact your process.
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Getting To Know MAM, The New Quality Control Strategy On the Block
When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.
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Exosome Isolation By TFF And Size Exclusion Chromatography
Here, we demonstrate a scalable workflow for the isolation of exosomes that combines tangential flow filtration for the concentration of exosomes followed by gentle size exclusion chromatography.
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A Scalable Single-Use Two-Step pDNA Purification Process
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
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High-Titer rAAV Production In Bioreactors Using Producer Cell Lines
Here, we detail the upstream process development and optimization for an AAV8-GFP proof-of-concept (PoC) producer single cell clone (SCC) in both batch and perfusion modes.
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Safer AAV Through Reduced Host-Cell DNA Encapsidation
While most hcDNA molecules outside AAV particles can be eliminated during downstream processing, encapsidated hcDNA molecules remain largely undetectable. Learn how to overcome this critical issue.
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Cost Modeling Comparison Of Bioreactors To Produce Adherent Cell Products
This study employs BioSolve software, a reference for cost analyses in the biopharmaceutical industry, to compare the upstream manufacturing costs between multitray stacks and the iCELLis™ bioreactor.
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Shocking! Biotech Facilities Don't Maintain Themselves
Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.
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Demand More From Your Oligo Synthesizer
The market for oligonucleotide therapeutics is expanding, and the pipeline is diverse. Gain insight into how you can fast-track your molecule's development with verified synthesizers, columns, and scientific support and expertise.
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Imagine The Future: Enhanced Oligonucleotide Synthesis
Learn about flexible control software that has revolutionized the way method creation, evaluation, and process optimizations for scale-up are completed.
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Insights Into GMP Manufacturing Of RNA-LNP Drug Products
Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, facility design, and strategic collaborations.
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
- Phase 3 Clinical Trial Completed In China For Boan Biotech’s Dulaglutide Injection BA5101. BLA To Be Filed Soon
- Biosimilars Forum Urges Congress To Support Free Market Competition And Lower Prescription Drug Prices For Patients By Reforming Pharmacy Benefit Managers
- Celltrion USA Completes Submission Of Biologics License Application (BLA) To U.S. FDA For CT-P39, An Interchangeable Biosimilar Candidate Of XOLAIR® (omalizumab)
- Samsung Bioepis Presents Two Abstracts For Its Immunology Portfolio At The 2024 American Academy Of Dermatology (AAD) Annual Meeting
- Fresenius Kabi’s Biosimilar Tyenne (tocilizumab-aazg) Becomes The First IV And Subcutaneous Tocilizumab Biosimilar Approved By The FDA