Effectively Managing Data In Process Development
Addressing data management challenges during drug development calls for a deeper understanding of the shortcomings of today’s methods and the factors you need to consider when adopting a solution to overcome them.
The Top 5 Biosimilar Developments Of 2020
Though 2020 felt like an endless descent into Dante’s Nine Circles of Hell, I wanted to end the year as I typically do: with a column highlighting the most important and positive biosimilar developments from the past 12 months.
Process Considerations For Closed Connected Processing
Closed connected processing poses new challenges with respect to process development, planning, and execution. This white paper reviews the benefits and challenges with closed processing and connected processing. By giving examples for the implementation of closed, connected processing in large-scale manufacturing, you will be able to explore and assess options that work for your objectives.
Lessons Learned Executing A Closed Connected Processing From Start To Finish
Biomanufacturing is under increased pressure to adapt to market demands, such as reducing costs and bringing life-saving therapies to the people who need it faster. We performed an evaluation of biomanufacturing technologies, which can potentially improve efficiencies, and offer our findings as additional data for consideration when adopting these methods. Read our recommendations from our execution of a closed and connected mAb process from design considerations to scale-up, including the small-scale modeling that directed our process at manufacturing scale.
The Second Wave Of Biosimilars: New Scenarios, New Rules
The arrival of what we could call the first “bio patent cliff” has revealed important lessons that should be taken into consideration when selecting new candidates for the second and third waves.
Biosimilar Experts Reflect On 2020’s Greatest Biosimilar Achievements
As the amazing members of the Biosimilar Development Editorial Board emphasize here, there is a lot to be thankful for in the biosimilar world. Check out the first of what will be a four-part series showcasing the editorial board’s thoughts on the past year and the year(s) ahead.
Is Biopharma Suffering From Thalassophobia? FDA Regulator Says Yes
As an FDA regulator explored in a recent presentation, biopharmaceutical manufacturing innovation has not kept pace with R&D. He shared several thoughts on why this may be the case, offering a call-to-action for the industry to reevaluate its notions of value to encourage greater manufacturing innovation.
A Model To Increase Yield In mAb Cell Culture Perfusion At Large Scale
As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows.
Using In-Line Sensors For Real-Time Control
There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.
Developing A Closed Connected Single Use mAb Purification Process
This article provides an overview of a successfully designed closed and physically connected mAb process at the pilot scale with single-use components.
Three Options To Viral Vector Manufacturing Capacity
A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.
A Modern Take On Cell Therapy Logistics
Here are my highlights on an International Society of Cellular Therapy (ISCT) 2020 session that introduced a new way to ship and transport cellular materials, putting patients front and center.
Key Considerations For Cryogenic Preservation And T Cell Viability
Illustrating how mammalian cells change when frozen, we offer cryopreservation strategies and identify temperatures at which it's safe to stop controlled cooling and transfer drug product to cryogenic storage.
Raise Your Upstream IQ: Process Development Optimization Considerations
How can you intensify your cell culture processes, in order to keep pace with today’s industry and regulatory expectations?
Biosimilars, Oral Biologics, & Continuous Processing: One Virtual Biotech’s Strategy
The (re)emergence of small biotechs in the biosimilar world has caught my eye in the last year. I sat down (virtually) with the CEO of one such company, BiosanaPharma, to discuss the advantages and challenges of being a virtual biotech pursuing biosimilar and novel biologic development.
ABOUT BIOSIMILAR MANUFACTURING
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.