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On the cutting edge
September 2018
by Jeffrey Bouley  |  Email the author
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Starting off our monthly check-in around new hardware and software in pharma, biotech and the life sciences is news from Goettingen, Germany-based Sartorius Stedim Biotech (SSB), a global supplier for the biopharmaceutical industry, which recently announced the launch of a new mini bioreactor vessel for its ambr 250 high throughput (ht) system. This new vessel, which was designed for optimal growth of adherent cells on microcarriers is expected to enable rapid, scalable cell culture process development of vaccines.
 
The single-use mini bioreactor for microcarrier culture has a working volume of 100 to 250 mL and features a single elephant ear impeller. This impeller type reportedly generates optimum mixing and suspension of microcarriers, allowing adherent cells to grow over the entire microcarrier surface. The new mini vessel is based on cell culture bioreactors in the ambr 250 ht system. Utilizing this bioreactor on the ambr 250 ht system is said to allow rapid scale-up of optimized adherent cell culture processes to SSB’s BIOSTAT STR range of pilot and manufacturing scale stirred bioreactors, resulting in shorter process development timelines than would be achieved by scientists using benchtop bioreactors and spinner flasks.
 
With up to 24 bioreactors per ambr 250 ht system, the technology is ideal for design of experiments studies to optimize process development for vaccine manufacturing using a quality by design approach, according to the company.
 
“There has been increasing interest in using microcarriers for culturing adherent cell lines in single-use stirred bioreactors as they offer a cost-effective alternative to two-dimensional approaches for vaccine production using T-flasks and roller bottles,” said Dr. Barney Zoro, ambr product manager at Sartorius Stedim Biotech. “We are proud to [have introduced] our new ambr 250 mini bioreactor for culturing adherent cells at the BPI European Summit. Scientists ... will find out how they can use our new mini bioreactor as a predictive model to help shorten their process development timelines and reduce their vaccine manufacturing costs.”
 
Helping eliminate inconsistent western blot results
 
MANSFIELD, Mass.—Scientists seeking reproducible data in their experiments are often confounded with the results from western blot assays, notes Precision Biosystems, as the steps for processing western blots require precise performance of blocking and antibody incubation. When these steps are performed manually, any error or variation that occurs is directly responsible for inconsistent results (Koller and Wätzig, 2005, Precision and variance components in quantitative gel electrophoresis, Electrophoresis, 26 (12):2470-2475). The BlotCycler, according the company, is “a simple and elegant system” designed to perform blocking, addition and incubation of primary and secondary antibodies and washing steps automatically.
 
BlotCycler is equipped with trays that can be configured to process up to 24 blots with six different primary and secondary antibodies simultaneously. Users simply add their antibodies and fill the BlotCycler tank with buffer solution, add blot membranes to processing trays and select the protocol for blocking, incubation and washing.
 
According to Precision Biosystems, “With precise timing, BlotCycler distributes buffers and antibodies, and performs controlled agitation for consistent processing. When blots are removed the automatic cleaning protocol is employed for thorough cleaning. The system accommodates most blocking and incubation protocols, and laboratories can continue using the same reagents.”
BlotCycler is capable of running multiple western blots using two different protocols simultaneously.
 
“People appreciate BlotCycler’s ‘walk-away’ capability for processing western blots,” said Dr. Russ Yukhananov, CEO of Precision Biosystems, “but the real value they find is BlotCycler’s ability to consistently deliver precise results. We have recently upgraded and tweaked BlotCycler. Our new 4 cm x 9.5 cm tray allows users to perform blots using even smaller volume of primary antibodies. We’ve also improved the tank design and material.”
 

Illumina receives approval for MiSeqTMDx in China
 
SAN DIEGO—Illumina Inc. announced in late August that its MiSeqTMDx Sequencing System received the approval certificate from the China National Drug Administration (CNDA). This is Illumina’s first CNDA-cleared, next-generation sequencing (NGS) system in China. In accordance with the clearance, Illumina can now market and sell the MiSeqDx Sequencing System to hospitals and other medical institutions for in-vitro diagnostic (IVD) testing throughout China.
 
Designed specifically for the clinical laboratory environment, the MiSeqDx is a benchtop sequencer that incorporates an easy-to-use workflow and data output tailored to the diverse needs of clinical labs. Taking advantage of proven Illumina sequencing by synthesis chemistry, the MiSeqDx is designed to provide IVD developers the tools to create accurate diagnostic tests. Additionally, integrated software enables run setup, sample tracking, user management, audit trails and data interpretation.
 
“The clearance of the MiSeqDx in China is a significant milestone for Illumina because it provides more opportunities for NGS,” said Garret Hampton, executive vice president of clinical genomics at Illumina. “More medical institutions and patients will now have access to the latest NGS technology. We are encouraging more clinical companies to select the MiSeqDx System to develop new clinical assays and to help provide needed solutions to some of China’s greatest health challenges.”
 
Looking more broadly, the company notes that the MiSeqDx Sequencing System now has regulatory approval in the United States, China, Canada, Argentina, European countries recognizing the CE-IVD mark, Australia, South Korea, Singapore, Thailand and the Philippines.
 

Looking to save researchers money
 
PISCATAWAY, N.J.—GenScript, a global gene synthesis provider, recently test-launched its new open-access plasmid platform, MolecularCloud. The platform aims to accelerate innovation in biology by promoting sharing of wisdom and supporting conversation among researchers.
 
“Today we reached an important milestone on our way to revolutionize how research is done,” said Eric Wang, vice president of marketing at GenScript. The new platform originates from a popular service offered by GenScript since 2015, known as CloneArk. This free service allows clients to archive clones from past orders at GenScript for future reuse. Three years into its launch, there are about one million clones in CloneArk system with deposits growing fast every day.”
 
“There are many benefits to use CloneArk,” added Dr. Lihua Zhang, senior product manager in charge of MolecularCloud project at GenScript. “For example, a researcher may repeatedly need the same piece of sequence during his/her project. For a 1500 bp gene, the cost of de-novo synthesis is about $525 while CloneArk-based synthesis would only cost about $125; up to $300 saving per clone, not to mention the time saved in the process.” According to Zhang, in 2018 requests for CloneArk-based synthesis will reach 45,000, indicating that GenScript will save as much as $13 million in funding for the global research community.
 
Before 2017 technical support at GenScript manually designed the right cloning strategy by blasting against client’s CloneArk database for selected customers. With the increase in CloneArk usage, GenScript developed GenSmart Ordering System, which automatically analyzes target sequences not only against previously-synthesized genes for the same client, but also in GenScript’s ORF clone collection to find the most time and cost efficient route for creating desired DNA constructs. In addition, GenSmart automatically detects and reports common errors in the design, including frame shifts, premature stop codons or insert direction issues in most commercial vectors. In 2018, the team took one step further to launch MolecularCloud, which allows reuse of clones made by other scientists who have decided to share their constructs in this public platform.
 
“We realized that there are still many scientists constructing clones in their lab although someone else had already published the same clone. This is not efficient. Obviously, CloneArk is not enough because it only provides access to reuse your own clones. So we decided to do something,” said Wang. “We designed a free platform for the community to share plasmids, which are then searchable through GenSmart and can be reused conveniently by everyone.”
 
Code: E091829

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