Our newsletter focused on the bioprocessing of biologics-based therapeutics and vaccines. In each issue, we’ll provide you with the latest news and topics of interest focused on optimizing your process and mitigating risk.
7 things to know about biosimilars
7 things to know about biosimilars The fast-growing biosimilars market is making significant strides in the industry as it continues to expand. Since 2015, the FDA has approved four biosimilars, which are sure to be the first of many more. However, with all the buzz around biosimiliars, there are some misconceptions that should be cleared up.
Productivity—doing more with less
The industry continues to drive to find process efficiencies and reduce costs. Here are some of our innovations that are helping our customers maximize their resources.
Improve capacity with fewer required vessels
We developed the Thermo Scientific HyPerforma 5:1 Single-Use Bioreactor (S.U.B.) to satisfy end-user interest in operating S.U.B.s at lower working volumes. This helps realize improved seed-train utilization and better mixing throughout drainage.
Efficient downstream processing of AAV viral vectors
Manufacturers of products for gene therapy face challenges developing efficient commercial capabilities. Thermo Scientific affinity chromatography for purification of these adeno-associated virus vector-based therapies offers clear advantages for obtaining high purity and high yield in a single step.
Outsource bioprocessing bulk liquid capabilities
Free up capacity and resources by partnering with us to help with your bulk liquid needs. We provide ready-to-use cell culture media, media supplements, buffers, and other process liquids, which are packaged in standard and BioProcess Containers (BPCs) from 1 L to 1,000 L.
A day in the life: focused on risk mitigation
Meet Janelle Halesworth, our business continuity management systems manager. “We are dedicated to developing, maintaining, and continually improving our business continuity management system in order to ensure personnel safety, a continuous supply chain for customers, and reduced risk and loss from business interruption events.”
Featured video: Novel methods for glycan analysis
Learn about the first glycan analysis method to combine both high throughput and high quality. View video ›
Join the conversation
Check out our weekly blog for the latest news and trends in the industry.
By the numbers: 14
Not-approved complete response letters issued by FDA in 2016, compared to 2 in 2015. The most common reason cited was non-compliance with cGMP regulations.*
* Mullard, Asher “2016 FDA drug approvals.” Nature Reviews Drug Discovery. February 2017. Pages 73–76.
Upcoming events
We look forward to connecting with you at an upcoming event to understand how we might partner together to optimize your process from reducing risk to increasing efficiency. A list of our upcoming events is included below or
| Dates | Event | Location |
|---|---|---|
| July 16-19 | PREP | Philadelphia, PA |
| Aug 22-24 | P-mec | Seoul, Korea |
| Sep. 12–13 | Bioanalytical/Analytical Summit | Prague, CZ |
| Sep. 17–20 | CE Pharm | Boston, MA |
| Sep. 25–28 | BPI Boston | Boston, MA |
Tell us what you think
We’d love to hear from you about suggestions and topics that you’d like to see featured in our newsletter or our weekly blog. We’re listening – send your feedback.