The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment. Using a combination of financial options analysis and decision analytics to quantify your options helps to embrace the uncertainty equation.
Using data analytics to drive continuous improvements in efficiency.
Using its Supplier Relationship Excellence (SRE) program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to better understand operational performance.
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.
Antibodies continue to dominate. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.
The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.
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.
Several drivers affect how the appropriate facility design and unit operations for a process are selected, making it imperative to properly evaluate each option.
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.
