Leverage this resource to accelerate biologic manufacturing of mAbs, vaccines, and novel biotherapies.
It is hoped that the development of biosimilars will lead to more competition, and therefore, more accessible, cost-effective treatments.
In Industry 4.0, cyber-physical systems control and monitor activity through computer-based algorithms. In bioprocessing, there are a plethora of possibilities that could be realized over time through this revolution.
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.
In this study, periodic counter current (PCC) chromatography and straight-through processing (STP) technologies were evaluated in a continuous three-step monoclonal antibody (MAb) purification process.
There is a lot of interest around continuous biomanufacturing, but could a hybrid of batch and continuous unit operations be the best solution for your process train?
How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.
Biomanufacturing requires large volumes of buffers, and preparation of these liquids can quickly become a bottleneck. Here, two options that can help intensify your large-scale buffer management are presented.
As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way.
Whether they be IP-,real-world-data-, or ongoing market-access-related challenges, biosimilar companies should expect a busy year ahead. Biosimilar Development's editorial advisory board members share the challenges they're keeping their eyes on.
Using a case study, the author demonstrates how comparative statistical analysis enabled his team to improve the yield of a component used in API synthesis by more than 2.5 x 108 U/batch.
Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.
In the first installment of this three-part Q&A, I asked the members of the inaugural Biosimilar Development editorial advisory board to share their thoughts on significant 2017 developments and how they expect these will impact the industry in 2018.
Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.
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.