2019 proved to be an exciting year for biopharmaceutical developers and process engineers, filled with both advancements and lessons. Considering how far the industry has come, what direction will 2020 take? Join us as we explore the top Bioprocess Development Forum articles from 2019 for insight into what 2020 may have to offer.
Novel Molecules Generate the Need to Address Challenges
With the arrival of next-generation biologics comes the need to tackle bioprocessing challenges head on, especially when it comes to separation and purification. Bioprocess Development Forum’s top article of 2019 addressed challenges associated with developing affinity ligands and support systems for novel protein-based biologics, as well as for a myriad of other biomolecules.
Speaking of purification, new types of molecules such as bispecific antibodies (BsAbs) have also created issues in this area. Bioprocess Development Forum provided insights into “navigating the jungle” that is BsAbs purification, which proved to be of exceptional interest to readers.
FDA approvals announced during the year for cell and gene therapies prompted the need to consider manufacturing facility designs specific to cell and gene therapy workflows, as well as the need to explore just how much flexibility and dedication these workflows require compared with other biotherapeutics.
Following the high interest in cell and gene therapies, there is a big interest in viral vectors, especially for adeno-associated virus, but also adenovirus. In 2019, a novel production process for adenovirus vectors—used in cancer gene therapy trials and evaluated for use in vaccines—got attention for its technical and process economic advantages compared with more traditional methods, all the while staying within regulatory guidelines.
Efficiency Improved by New Technologies
Technological advances showcased during the year generated high interest in Bioprocess Development Forum and demonstrated improved efficiency for a range of applications, including perfusion processes and downstream processes using Fibro, a novel cellulose fiber chromatography technology. Readers were particularly interested in learning how Fibro technology can be used in conjunction with ÄKTA™ chromatography systems and autosamplers to reduce process time significantly when compared with conventional chromatography.
QbD, Regulatory, and Validation Considerations
Viral clearance is a topic on the minds of many in the biopharma industry, and for good reason. Considering the manufacturing challenges experienced in this area, it makes sense that readers often referenced Bioprocess Development Forum’s article on the basics of assessing viral safety when validating a biomanufacturing process with a focus on chromatography, as well as another article on chromatography column considerations.
Despite acknowledgment of how valuable process analytical technology (PAT) is to various biomanufacturing processes, the industry has been somewhat slow to adopt PAT-focused platforms and services for a host of reasons that include regulatory and cost issues. However, technological advancements made during 2019, as well as increased overall understanding of the concept, have sparked optimism that PAT will soon become a widespread reality for real-time release testing.
When it comes to raw material variability, process developers face a range of challenges as a result of molecular diversity and a need for higher productivity, such gaining a deeper understanding for sources of variability and set mitigation strategies. For this reason, readers showed great interest in an article providing insight into how raw material variability is a potential source for process variation.
Also Popular on Bioprocess Development Forum
Along with the previously mentioned pieces, the following articles were among the most popular published in 2019:
Are You in Control of the Quality of Your mAbs?
Supply Chain Challenges for Single-Use Systems
The Good and Bad of Biosimilars
Getting it Right from the Start in the Drug Development Process
Monitoring and Control of Inline Dilution Processes
Increase Efficiency in Experimentation with Design of Experiments
Four Steps Toward End-to-End Connected Manufacturing