JSR Life Sciences (JLS) today announced that KBI Biopharma (KBI), a subsidiary of JSR Corporation (JSR), is expanding its biopharmaceutical manufacturing capacity and capabilities at both its Durham, North Carolina and Boulder, Colorado facilities. KBI is investing approximately $30M on the two site expansion projects, which will greatly enhance the offerings at each site and are scheduled for completion later this year. KBI is building commercial mammalian cell culture manufacturing capability within its Durham facility, which also houses CGMP cell…
Author Archives: BPI Contributor
Quantum ReNu SU Technology® Validation Guide and Performance Testing Summary
As the use of disposable systems within biopharmaceutical manufacturing has moved from niche preclinical applications to large scale commercial processes. This has led to the requirement for novel technologies that improve processing throughput and allow manufacturers to increase their output. To this end, WMFTG has developed a new pumping technology to enable end-users to meet their downstream processing needs for unit operations such as chromatography and tangential flow filtration (TFF). Quantum allows end-users to use novel peristaltic technology for their…
Achieving Continuous Downstream Bioprocessing Through Multi-Column Chromatography (MCC)
In recent years, improving downstream manufacturing has become an emerging challenge to the biopharmaceutical industry. Initially, the bottleneck in biopharmaceutical manufacturing existed in the output of bioreactors. Due to advances in cell line development and upstream process (i.e., perfusion), the output of bioreactors has increased at a much faster pace than downstream processing capacity. Therapeutic biologics, including monoclonal antibodies (mAbs), represent the fastest growing segment of the pharmaceutical market. By 2019, the biological market is expected to exceed 20% of…
BIOne – Single-Use Bioreactor System
Convert your existing benchtop glass bioreactor to a single-use bioreactor in seconds. Distek, Inc. has developed a benchtop scale single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production. The pre-sterilized BIOne system is engineered with a disposable headplate welded to a triple-layered liner that can be easily inserted into a non-sterile bioreactor glass vessel, converting it to a sterile, disposable SUB within a matter of seconds. Simply remove your existing headplate and place the preassembled and irradiated…
Continuous Processing Optimization With Smarter Tools
Single-use technology (SUT) has long been viewed as a viable solution to today’s biopharmaceutical manufacturing challenges. It offers the flexibility to change a production configuration to meet demand while also offering many other cost benefits, such as savings related to the elimination of clean-in-place (CIP) and sterilization-in-place (SIP) processes. However, traditional and fed-batch models fail when trying to adapt to single-use flexibility due to the required rewriting of code and revalidation. The best way to use the flexibility of single-use…
MilliporeSigma Develops Alternative CRISPR Genome Editing Method
MilliporeSigma has developed a new genome editing tool that makes CRISPR more efficient, flexible and specific, giving researchers more experimental options and faster results that can accelerate drug development and access to new therapies. This new technique, called “proxy-CRISPR,” provides access to previously unreachable areas of the genome. Most natural CRISPR systems, found in bacteria, cannot work in human cells without significant re-engineering. However, proxy-CRISPR provides a rapid and simple method to increase their usability without the laborious need to…
Impact of Single-Use Tangential Flow Filtration in Downstream Bioprocessing
This webcast features: Michael LaBreck, Sales Director, Repligen TagenX Products Single-use solutions are fast becoming platform in bioprocessing as a response to pressure to optimize process economics and process efficiencies. Implementing single-use alternatives in tangential flow filtration (TFF), a critical step in downstream bioprocessing for concentration and diafiltration (buffer exchange), is a major part of this transformation. Repligen TangenX™ SIUS™ Single-use Cassettes are the first purpose-built cassettes designed for tangential flow filtration. This webinar will demonstrate how deploying these innovative…
Sartorius Stedim Biotech Partners with Nova Biomedical
Sartorius Stedim Biotech (SSB), a leading international supplier to the biopharmaceutical industry, today announced an agreement with Nova Biomedical (Nova), a well-known US manufacturer of cell culture analyzers, to integrate their BioProfile® FLEX2 into the ambr® multi-parallel bioreactor systems for automated, at-line cell culture analytics. SSB and Nova are collaborating to combine two highly innovative technologies. Both the BioProfile® FLEX2 analyzer and the parallel bioprocessing functionality of the ambr® create a unique tool able to simultaneously run, sample and analyze…
MilliporeSigma Launches Industry’s First Off-the-Shelf Cell Culture Media for Perfusion Processes
MilliporeSigma, today took a significant step toward increasing manufacturing flexibility and enabling higher productivity with the launch of the EX-CELL® Advancedâ„¢ HD Perfusion Medium. This first off-the-shelf, high-density cell culture media supports perfusion processes and facilitates high productivity at low perfusion rates, increasing production yield and speed to clinic. Biomanufacturers are moving toward perfusion processes, the next generation in manufacturing, as they seek to cut costs while increasing quality and efficiency. Perfusion processes, however, require a new type of medium…
JSR Life Sciences Expands Amsphere™ A3 Production Capacity
JSR Life Sciences (JLS), the global life sciences focused division of JSR Corporation, today announced plans for expansion of its production capabilities of Amsphereâ„¢ A3 protein-A chromatography resin at JSR’s Belgium subsidiary, JSR Micro NV. This expansion will effectively increase its production capacity by six times and provide redundancy in its manufacturing capability. JLS’s Amsphereâ„¢ A3 has experienced rapid adoption as an alkali-stable, high-capacity alternative option for downstream purification in the biopharmaceutical industry since its launch in January 2016. Based…