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On the cutting edge
June 2020
by Jeffrey Bouley  |  Email the author
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Clinical trial protocol design is getting a boost from patient input thanks to Transparency Life Sciences (TLS), which in mid-May announced the debut of a novel patient-centric protocol builder for clinical trials called Transparency Protocol Crowdsourcing (TPC).
 
Describing the product as “a combination of technology and service,” the company says that TPC engages patients, physicians and researchers to contribute to the setup and design of trials using a proprietary online survey tool. The results are then analyzed using AI-enabled natural language processing and TLS’ proprietary advanced analytic tools to help sponsors draft protocols more relevant to patient needs and clinical practice.
 
Reportedly, the technology can also help understand patient behavior utilizing historical data, thereby enhancing engagement.
 
Further, citing research to support the need for such technology, TLS noted that a study in Therapeutic Innovation & Regulatory Science indicated that incorporating a diverse and broad patient voice early on in trial design can result in an increase in net present value over $60 million, while expediting time to market by up to 2.5 years.
 
“People are becoming more involved with their healthcare choices and have always been motivated to enroll in clinical trials to help find new treatment options that will benefit everyone, so it’s only appropriate that trial sponsors incorporate a diversity of patient voices and rethink their approach to protocols, design and other parts of the trial that could benefit from patient input,” said Harry Glorikian, CEO of TLS. “By using a tool like TPC, the pharma and biotech companies gain capabilities to help speed up the process while satisfying key guidelines and reducing the overall trial cost.”
 
Now, having covered some technology that’s a bit more novel in terms of function and approach, we have a few more things to cover among the workhorses of traditional day-to-day work of pharma and life sciences, so keep reading to see if it’s something you need in your lab.
 
Superior separation for high-order aggregates and macromolecules
KING OF PRUSSIA, Pa.—Tosoh Bioscience LLC, a provider of chromatographic solutions for the separation of biomolecules, announced recently the introduction of TSKgel UP-SW Aggregate size exclusion chromatography (SEC) columns.
 
As the company pointed out in the announcement, antibody therapeutics are enjoying high growth rates, with the major areas of therapeutic application being cancer and immune/inflammation-related disorders like arthritis and multiple sclerosis. With that in mind, Tosoh noted, “Today, new antibody formats are entering clinical phases, with some of the new formats having a higher molecular weight than conventional antibodies. The biological phenomenon of protein aggregation is a major issue in therapeutic protein development, since the presence of these impurities reduces the potency of the drug formulation, even if non-toxic. Monoclonal antibodies must be free from these aggregate impurities.”
 
And size-exclusion chromatography is a widely applied technique for protein characterization and quality control. The new columns feature high pore volume per unit column volume, low sample adsorption (due to the derivatization of the particle surface with ligands containing diol functional groups) and what Tosoh calls “excellent” column efficiency, all contributing to what it says is unsurpassed sample resolution.
 
“This newest line of UP-SW columns offers all the first-in-class qualities users have come to expect from TSKgel SEC SW columns, with the added advantage of the higher exclusion limit for analysis of high molecular weight proteins and impurities,” said Philip Hoang, technical marketing specialist for analytical chromatography at Tosoh.
 
Liquid-stable enzyme calibration verification
PROVIDENCE, R.I.—Verichem Laboratories has announced the availability of a ready-to-use, liquid-stable product expressly designed for the calibration verification of any “wet” chemistry testing system. Specifically, the Enzyme ER Verifier Kit is a multi-analyte, six-level verifier kit of liquid stable materials, comprised of nine separate clinical enzyme components and covering a total of 54 individual activities.
 
The enzyme components included within in the materials include amylase, ALT, ALP, AST, cholinesterase, CK, GGT, LD and lipase. According to the company, “The availability of this unique kit is certain to address the needs of a wide variety of medical laboratory professionals, including those involved with clinical testing, research applications, and in the development and manufacturing of in-vitro diagnostic products.”
 
The company says the new kit “represents the cutting edge in enzyme test calibration verification materials, as its proprietary formulation is specifically designed to include at least one set point for each enzyme in the normal range. Plus, the use of purified source components and liquid format eliminates matrix variations and reconstitution errors common with lyophilized or serum-based products. In addition, the material’s protein balance, pH and ion content are constant across concentration levels for optimum linearity.”
 
Reportedly, the linear relation for the set is included in the product insert so the kit can be used for reportable range verification of any automated wet chemistry method. Plus, for added convenience, a separate value assignment sheet is included with targets for popular Abbott, Beckman Coulter and Roche Diagnostics clinical chemistry systems.
 
Focused solutions for cell culture workflows
WAYNE, N.J.—ProCulture, a new workflow-minded product line for cell culture from Bel-Art and Wilmad-LabGlass brands (and available through SP Scienceware), covers multiple steps of the cell culture process from isolation to harvesting. Products include an array of shaker flasks and spinner flasks with a unique impeller that is said to increase aeration and eliminate dead spots, as well as an orbital shaker platform that converts an existing magnetic stir plate into an orbital shaker at a fraction of the cost of an orbital shaker.
 
“The ProCulture line includes products that can simplify researchers’ cell culture experiments,” explained Kathleen Hanek, portfolio manager for SP Scienceware. “There are tried-and-true items such as shaker flasks and storage racks, as well as products you can’t find anywhere else.”
 
Code: E062028

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