A biosimilars boom is expected and both biopharma and contract manufacturers want to be positioned to capture a piece of the market. ISR’s Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (4th Edition) goes into depth on one of the most important aspects of biosimilars: manufacturing.
Fast and efficient process development and scale-up contributes to a shortened time to market. This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.
Calculation examples that highlight scenarios where the enhanced capacity and alkaline‑stability of MabSelect PrismA can provide process economic benefits to large‑scale mAb processing.
I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
This application note examines these aspects of using sodium hydroxide as a cleaning and sanitizing agent.
A demonstration of the long‑term chromatographic performance of MabSelect PrismA during repeated purification cycles using 0.5 M NaOH for CIP.
This application note demonstrates the binding capacity of MabSelect PrismA in comparison with its predecessor products for both polyclonal and monoclonal antibodies.
To drive appropriate and dependable critical process control requirements, Biogen explored several novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.
Although change may be intimidating, disruptive innovation allows manufacturers to achieve increased efficiency and quality. Several drivers affect how the appropriate facility design and unit operations for a process are selected, making it imperative to properly evaluate each option.
This study presents how strategic enhancements to the sparge and agitation systems of Thermo Scientific™ HyPerforma™ S.U.B.s have revealed the potential for a three- to four-fold improvement in mixing and mass transfer performance compared to legacy S.U.B. designs.
The aggressive performance demands of industrial microbiology have limited the conversion of traditional fermentation processes into single-use systems. In order to address the unique needs of microbial applications, single-use fermentors have been designed to meet the requirements of microbial fermentation instead of being modified from a cell culture bioreactor.
A collaborative study with a new customer with the objective of taking an existing, smaller preclinical E. coli process previously performed in stainless steel vessels and scaling it up quickly using the Thermo Scientific™ HyPerforma™ 300 L Single-Use Fermentor (S.U.F.)
With today’s complex manufacturing systems and processes, can a manufacturer afford to not have a centralized automation platform?
Manufacturing viral vector-based therapies such as vaccines and gene and cell therapies is complex, but a new manufacturing solution helps solve those challenges.
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.
