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.

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.

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.

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 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.

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.

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.

As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows. 

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.

This article provides an overview of a successfully designed closed and physically connected mAb process at the pilot scale with single-use components.

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.

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.

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.

How can you intensify your cell culture processes, in order to keep pace with today’s industry and regulatory expectations?

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.