Bioprocess and Process Analysis

Bioprocess Analysis

Company Announcements

Hamilton Bonaduz announced in March the appointment of Dr. Clara Caminada as vice President of the Business Unit Process Analytics. She previously led the Unit’s marketing department.

In March, MilliporeSigma signed a memorandum of understanding with Schneider Electric that aims to automate biopharmaceutical processes for China’s biopharmaceutical industry. The memo includes comarketing.

In May, MilliporeSigma opened its first BioReliance End-to-End Biodevelopment Center in North America to help customers with biopharmaceutical manufacturing processes. The Center provides cell line–development services, upstream and downstream process development, and non-GMP clinical production for drug manufacturers. The company also announced the expansion of its Advance Biotech Grant Program. Every six months, three recipients will be awarded a total of €200,000 ($234,000) in free services and products to address their process development challenges. In total, six companies will benefit from MilliporeSigma’s Advance Biotech Grant Program each year.

In April, Pall entered into a strategic collaboration involving its Biotech business unit and Artesyn Biosolutions, a innovator in single-use components and fluid management technologies. The companies will codevelop complete solutions from clinical to commercial scale for single-use automated bioprocessing systems. The partnership furthers Pall Biotech’s expansion of its Allegro single-use solution portfolio from upstream through downstream, and to final filling.

 

Product Introductions

In February, ABEC announced large-scale single-use microbial fermentation capability, demonstrating its CSR technology’s performance with working volumes up to 1,000 L.

In March, Sartorius Stedim Biotech launched the ambr 250 high throughput (ht) perfusion, a new automated parallel bioreactor system designed for rapid cell culture perfusion process development to optimize production of therapeutic antibodies. It combines 12 or 24 single-use perfusion mini bioreactors (100–250 mL working volumes) with associated single-use perfusion components, all controlled by one automated workstation.

In April, Sartorius Stedim Biotech introduced a new mini bioreactor vessel for the ambr 250 ht system for cost­ effective, scalable process development of vaccines in cell culture.

Aquila biolabs released in March the Cell Growth Quantifier BioR (CGQ BioR), which allows for noninvasive online biomass monitoring in all scales and types of bioreactors. It attaches to the outside of the bioreactor and uses backscatter measurements.

In April, aquila biolabs debuted the is LIS (liquid injection system) Software for the wireless control and monitoring of feeding experiments.

 

Process Analysis

Company Announcements

Earlier this year, Gasera expanded its operations in Germany, opening a local sales office in Nürnberg.

In March, Keit joined CAMO Software’s OEM Partner Program. CAMO’s chemometric software can now be integrated with Keit’s IRmadillo on-line sensor for real-time process monitoring.

In May, Princeton Instruments and the Center for Structured Organic Particulate Systems (C­-SOPS) entered into six-­month collaboration on a novel pharmaceutical technology that enables close monitoring and control of drug manufacturing processes. The project will use Raman spectroscopic measurements to monitor the formation of thin oral films, which contain medicine and dissolve in the mouth without the need for water, including in the drying process during manufacturing, in order to determine drug amount, uniformity and form. In addition, it will investigate the degradation processes of APIs in solid ­dose drugs.

Picarro announced in June a partnership with Challentech International  to distribute its latest gas analyzers, the SI2000 analyzer series, in China and Taiwan.

 

Product Introductions

In February, Modern Water debuted the Microtrace OVA 7100 Series for on-line trace-metal monitoring. It can be configured to measure up to 23 different metals with detection limits as low as 0.1 µg/L.

In March, In-Situ released the wireless-enabled Aqua TROLL 500 multiprobe for both surface-water spot checks and long-term monitoring.

Picarro added in March new capabilities to all of its cavity ring­down spectroscopy-based  SI2000 Series gas analyzers. For hydrogen fluoride, ammonia and hydrogen chloride, the new SI2000 Series analyzers provides extended measuring range from mid-ppb to ppm concentration levels.

In April, Thermo Fisher Scientific introduced the new Thermo Scientific SOLA iQ total sulfur analyzer. The online analyzer offers an updated modular design that eases routine maintenance and features measurement ranges from 2 ppm to 100% and limits of detection as low as 25 ppb.

Schneider Electric released its new FXI Series 7 Process GC in June. The FXI Series 7 GCs enable multiple detectors and ovens to be utilized simultaneously to decrease analysis time, and are geared towards petrochemical, refining and chemical plant applications.

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