To quickly deliver their product to patients in need, Reneo Pharma teamed up with Thermo Fisher Scientific to take advantage of its Quick to Clinic for Oral Solid Dose program.
Today multiple suppliers offer commercial process solutions for continuous cell culture, continuous clarification, continuous chromatography, continuous virus inactivation and continuous filtration and their effectiveness is documented in the technical literature. So, what’s next? We have the tools; the technology is proven and early adopters are active.
Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.
The motivation for utilizing single use (SU) bioreactors is the reduced turn-around time and labor required for cleaning and autoclaving traditional glass vessels as well as the associated costs for maintenance and repair. Sartorius’ 2L UniVessel® SU has an option for an external water jacket system controlled by Sartorius’ BIOSTAT® controllers. In this study, we determined the feasibility of the UniVessel® SU and BIOSTAT® B-DCU II combination by performing detailed comparability studies of cell growth, viability, monoclonal antibody (mAb) productivity and product quality attributes (aggregation, charge variation and glycosylation) using three recombinant CHO cell lines.
Appropriating BPOG testing on single-use connectors to mitigate the risks of E&L, as demonstrated in this article, is crucial to delivering safe and effective drugs.
What is the difference between qualification and validation? This question comes up frequently with both internal and external clients.
CPC has an army of biopharma experts ready to provide you with highly-tested bio-pharma connectors and global support.
Watch the video to meet Patheon’s (part of Thermo Fisher Scientific) API drug substance team and get an inside look at their Florence, SC facility.
IASO supports stakeholders who are responsible for bringing innovation to market in the form of combination products for oncology.
The industry is looking for answers about the implementation of continuous bioprocessing. Pall Biotech is here to help you to find them. Watch our video for quick insights into bioburden control strategies in continuous bioprocessing.
When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection they are able to communicate what is unique about their offering to the right audience at the right time.
This video introduces Singota Solutions, a CDMO focused on getting products to patients faster by being agile, accountable and transparent. A team of industry experts help virtual to large pharma clients reach preclinical and clinical milestones faster with shorter lead times and agile onsite operations. Services in formulation development, finishing and supply chain support Singota’s flagship aseptic filling operations. A gloveless robotic isolator provides highly repeatable and precise filling for high value drug products.
Samsung Biologics is a full integrated CDMO with the largest capacity in the world. We provide development and manufacturing services for biopharmaceutical companies of any size.
The efficacy and safety of biopharmaceutical products, combined with their ability to address previously untreatable conditions is driving strong demand. Concurrently, to accelerate access to life-changing medicines, the number of breakthrough therapies and fast track designations are increasing, shortening drug development timelines considerably.
As the biopharma industry identifies faster and more efficient ways to deliver drugs to patients, such as break-through and fast track designations for accelerated approval, these progresses create pressure on both large and small drug manufacturers. As development timelines shorten, decisions related to drug commercialization need to be taken earlier, when key results are not yet available. And deciding on the scale and type of facility to build without complete data can create substantial risks with costly consequences.