An easy two-step protocol to purify adenoviruses.
A small biotech company faces specific challenges when navigating both the biosimilar and the innovative space. I wanted to get a better sense of how smaller companies originally defined as biosimilar pure-plays, like Pfenex, are ensuring longevity in the biosimilars space.
It takes more to enter the biosimilar business than simply being a leading innovator in the biologics space. As several Pfizer experts shared, there are some integral transitions, both in mindset and in terms of practice, that need to occur to fully embrace biosimilars.
In this e-book, you’ll find insight and advice from some of the industry’s top experts about current trends in biomanufacturing, modern process intensification techniques and the outlook for digital automation. We’ll explore innovative process approaches that can be applied at various scales and stages of development in hopes of providing you with a visionary guide of how to effectively manufacture your molecule.
How product design influences biopharmaceutical manufacturer extractable profiles.
Improved productivity using a Nunc High Density Cell Factory 52-layer system.
Helpful methodology that can be applied to the large-scale expansion of other cell types for use in various applications using Cell Factory systems.
Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.
As the need to accelerate biopharma development continues to grow, these case studies describe projects in which collaboration resulted in fast resolutions to common biomanufacturing challenges.
It is hoped that the development of biosimilars will lead to more competition, and therefore, more accessible, cost-effective treatments.
Currently, there is a transformation taking place that will pave the way for even more changes to how the industry approaches drug manufacturing.
Understand how in-line preparation of buffers from highly concentrated, single-component stock solutions saves both time and storage space.
The large buffer volumes required for biomanufacturing can be a bottleneck, especially when scaling up. Just-in-time buffer preparation can be the solution.
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.