Using a shared biomanufacturing facility, a biomanufacturer can minimize its investment while mitigating the risks of demand uncertainty and maximizing time to market.
Trevor Marshall of Zenith Technologies discusses the impact that multi-product manufacturing facilities, single-use technologies, continuous manufacturing and industry 4.0 will have on automation.
Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.
As Pfizer began its pursuit of delivering two biosimilar monoclonal antibodies (mAbs) in China, it sought a partner that could mitigate the risks of expanding into this region while also significantly reducing the development timeline. By leveraging the expertise of an experienced partner and the benefits of single-use technology (SUT), Pfizer was able to quickly establish a global footprint while also gaining a competitive advantage in an emerging market.
Scaling up a bioprocess doesn’t need to be a headache – especially when there are firms out there that can lend a helping hand.
One solution to drug development challenges is adopting a parallel operations business model. This article offers recommendations for how parallel operations can be leveraged in a biomanufacturing strategy.
By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.
Adenoviruses are commonly used as gene transfer vectors in gene therapy and clinical trials. However, their large size, complexity, and acid labile nature lead to challenges in their downstream purification.
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).
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.