January 31, 2019

Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions

process developmentThe biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back at some of the most popular Process Development Forum articles from 2018 for clues about what may unfold in 2019.

Interest in Cutting-Edge Therapies Continues to Grow
With FDA’s first approvals of cell and gene therapies now more than a year old, activity in these areas shows no signs of slowing down. Process Development Forum readers were clearly interested in keeping abreast of the latest news surrounding the manufacturing of these important therapies. In fact, two out of five of the most popular 2018 articles related to cutting-edge therapies.

One piece focused on regulators’ efforts to address the “challenges of developing and validating relevant manufacturing processes” and expediting standards for the research and development of cutting-edge therapies.

Readers also wanted to learn about specific solutions for downstream processing, with another hot article being an application note describing the development of downstream chromatography steps for the purification of adenovirus from HEK293 cell culture harvest.

Single-Use Technologies Are Still Growing—But Not Without Challenges
Single-use technology is said to offer a plethora of benefits in the production of biopharmaceuticals and biosimilars, including cost savings, increased efficiency, accelerated development, production flexibility, and more. Clearly, industry members (including Process Development Forum readers) are extremely interested in learning about what these solutions have to offer, but the adoption of single-use systems is still considered to be low. Such was the viewpoint of one popular article, which explored some stumbling blocks to wider spread adoption of single-use systems in the biomanufacturing arena and how capacity needs are changing.   

Of note, hybrid single-use systems still dominate biopharmaceutical production. Readers were particularly interested in the perspective of one writer who explained why he believes single-use technologies will not completely replace reusable systems in the near future.

Process Intensification
Process Development Forum readers spent a fair amount of time exploring ways to bring process intensification to their lines. 

Continuous processing and scalability, for instance, seems to be a key concern for Process Development Forum readers, many of whom downloaded a poster showing that periodic counter current chromatography is a robust and scalable technology. Numerous readers also explored semi-continuous processing, specifically an application note about how various unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.   

Readers also wanted to dig into other tools for process intensification such as buffer management. One hot article answered two commonly asked questions about in-line buffer preparation, which were “Will our buffers work?” and “How can we be convinced that buffers are made to specification?”   

Also popular in 2018 was an article covering the optimization of fed‑batch culture conditions, which describes a broadly applicable and efficient workflow for finding the optimal feed combination for the best-performing fed-batch processes.

Understanding the Regulatory Environment
Regulatory-focused articles were the most popular 2018 posts on the Process Development Forum, with validation and tech transfer being especially important topics for readers. In fact, the top 2018 article was the first of a three-part series covering process validation, defining key terms and exploring why process validation is necessary. The other two parts of this series (Part 2 | Part 3) were also among the top dozen articles of 2018. 

The second most popular article of the year gave readers the chance to learn about ways to prevent bioburden entry and proliferation. 

It’s interesting to note that even older articles related to these topics (like a 2013 article on cleaning validation and a 2017 article on preparing for an FDA bioburden inspection) were still engaging readers 1–5 years after their initial publication.

Other Top Process Development Forum Articles of 2018

In addition to the aforementioned articles, the follow pieces were among the most viewed Process Development Forum articles published in 2018:

•  Chromatography Scale-Up: Don't Get Tied Down by Bed Height

•  Combine Chromatography Techniques: Get the Right Purity/Yield of Protein 

•  Impurity Testing of Biologic Drug Products 

•  Tools and Solutions for Separation of Charged mAb Variants 

•  Modern Manufacturing Key to More Effective Vaccines 

•  Evaluation of Performance of a Disposable mAb Affinity Chromatography Column Used Over Multiple Process Cycles 

•  Optimization of Fed‑Batch Culture Conditions for a mAb‑Producing CHO Cell Line 

•  How to Determine Dynamic Binding Capacity (DBC) of Chromatography Resins

Tags: biopharma, manufacturing, 2018, process development