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Scaling Up The Learning Curve For Large-Scale AAV Manufacturing
The complexity of manufacturing AAV products, coupled with the challenges linked to controlling their costs, underscore the importance of improving the efficiency and scalability of these processes.
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FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection
The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
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Is Your Lab Ready For A LIMS Implementation?
Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.
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Cytiva P-Grade Depth Filters For CHO Cell Culture Clarification
Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of Stax™ mAx depth filters, demonstrating their effectiveness.
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5 Recommendations To Maximize CSV/CSA Outcomes
The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
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Bacterial Endotoxin Testing, Part 1: Overview
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
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CAR T Set The Pace So All Can Win The Cell Therapy Race
Gain insight into the modest origins of cell therapy manufacturing and how this history has paved the way for future advancements from Bill Shingleton, R&D Leader at Cytiva.
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Derisking Biomanufacturing: Why A CDMO In Poland Might Be Your Secret Weapon
The current geopolitical climate is leading drug developers to consider global manufacturing partnerships strategically. Identify a CDMO partner that will help protect your IP, save money, and mitigate risk.
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TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications
Explore data showcasing the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.
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Filtration Methods To Overcome New Challenges In Viral Safety
This study offers valuable insights to guide informed decisions in virus filtration, aligning with both the PDA TR-41 (2022) and ICH-Q5A guidelines.
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System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks
Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
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The Benefits Of Outsourcing Your Biomanufacturing To A Polish CDMO
As you search for a global manufacturing partner, consider the benefits of working with a CDMO based in Poland, including high quality and technical precision at an attractive cost.
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Media And Buffer Mixing Using The Xcellerex™ Magnetic Mixer
A common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.
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High Power Mixing At Large Scale: An Overview Of The Xcellerex™ Magnetic Mixer System
Explore the advantages of 2000 and 3000 L single-use mixing systems and experimental results demonstrating their capacity to deliver high power at large scales and flexibility for use at lower volumes.
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Determining The Power Numbers For A Single-Use Mixing System
In designing a mixing process for scale-up, the power number is a critical parameter. Explore the determined power numbers for a single-use mixer at various mixing speeds and fill levels.
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
- Sandoz Launches Biosimilar Pyzchiva® (ustekinumab) Across Europe, To Treat Chronic Inflammatory Diseases
- Kashiv BioSciences Announces Completion Of Enrollment For Phase III Clinical Trial Of ADL018, A Biosimilar Candidate To XOLAIR (Omalizumab)
- Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial For BAT3306, A Proposed Biosimilar Of Keytruda® (Pembrolizumab)
- Bio-Thera Solutions Announces Regulatory Filing Acceptance For BAT2206, A Proposed Biosimilar To Stelara® In The US And EU
- FDA Approves Samsung Bioepis' EPYSQLI® (eculizumab-aagh) As A Biosimilar To Soliris (eculizumab)