Pharmaceutical Technology Editors

OGT, a Sysmex Group company and supplier of clinical and diagnostic genomic solutions, announced the launch of the SureSeq Myeloid Plus panel and OGT Universal Next Generation Sequencing (NGS) Complete Workflow on Oct. 5, 2022. The SureSeq is designed to detect aberration in genes implicated in various myeloid disorders, while the workflow is designed to significantly reduce hands-on-time when working with hematology, inherited, and rare disease panels.

According to a company press release, the new SureSeq panels is able to detect single nucleotide variants (SNVs), insertion–deletion mutations (indels), internal tandem duplications (ITDs), and partial tandem duplications (PTDs) within 49 genes. These genes are associated with myeloid disorders, including acute myeloid leukemia (AML), myeloproliferative neoplasms, and myelodysplastic syndrome, among others.

The product is designed to deliver coverage uniformity for low-frequency variants, even in difficult-to-sequence adenine-thymine/guanine-cytosine (AT/GC)-rich regions and regions covering ITDs and PTDs. According to the release, these are common somatic variants in AML and are often associated with poor prognosis and an aggressive form of the disease.

The NGS Workflow is designed to complement the panel, which is designed to be more amenable to automation. According to the release, the Workflow has been upgraded with improvements in copy number variant interpretation, annotation, visualization, and sample data import and display.

“Thanks to our unmatched expertise in bait design, and through partnering with leading cancer experts, we have developed a powerful tool for myeloid research with a highly efficient workflow,” said Adrian Smith, CEO, OGT, in the release. “This enables clinical researchers to quickly and confidently detect all relevant variants in one simple assay. NGS is a key area of expertise for OGT, and we have exciting plans and possibilities for the future.”

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OGT has launched the SureSeq Myeloid Plus panel and OGT Universal NGS Complete Workflow.

OGT Launches New Panel and Workflow Solutions

Thermo Fisher Scientific recently announced the DynaSpin Single-Use Centrifuge system, a centrifuge that is specifically designed to provide optimal single-use solution for large-scale cell culture harvesting. The system aims to improve and streamline the process by reducing the number of depth filtration cartridges required to complete the harvest process.

According to a Sept. 28, 2022 press release, by reducing the number of filters required for harvesting, the DynaSpin offers upwards of six-fold reduction in material requirements. This is estimated to eliminate approximately 70% of waste compared to traditional harvest systems.

“We developed the DynaSpin system with an eye on efficiently harvesting biologics at large-scale,” said Srini Paluri, vice-president and general manager, Bioprocess Equipment & Automation, Thermo Fisher Scientific, in the release. “It was critical that the solution also consider the environment while outperforming traditional harvest solutions and delivering consistent product yields to our customers.”

The DynaSpin is designed for scalability, rapid changeover, reduced downtime, and lower risk of contamination to the workflow, according to the release. It also features configurable user access, audit trail, and batch reporting.

Thermo Fisher’s new centrifuge technology is designed to enable efficient, sustainable cell culture harvesting.

Thermo Fisher Scientific Launches Large-Scale Cell Culture Harvesting Solution

Freudenberg Medical, a medical and pharmaceutical devices, components, and tubing manufacturer, announced the launch of the HeliFlex Thermoplastic Elastomer (TPE) tubing on Sept. 29, 2022. The Heliflex is a high purity TPE designed for biopharmaceutical fluid transfer applications.

According to a company press release, the HeliFlex is ideal for bioprocessing applications because it can be heat-sealed to allow for easy, fast, and safe fluid transport and transfer. Additionally, the product can be welded to existing tubing lines, is sealable, translucent, and can be used in peristaltic pumping applications.

The tubing is offered with various sterilization options, including autoclave, gamma irradiation, x-ray, and e-beam. According to the release, it is a more environmentally friendly option than silicone, as it can be recycled.

“Silicone has always been the gold standard for biopharma applications,” said David Schwass, director, Sales & Marketing Biopharm, Freudenberg Medical, in the release. “But with silicone material in short supply over the past few years, Freudenberg wanted to offer global customers another single-use tubing alternative.”

Freudenberg Medical’s Heflix TPE tubing is a high purity TPE intended for bioprocessing applications.

Freudenberg Medical Launches HelixFlex TPE Tubing 

Colonis, a subsidiary company of the Clinigen Group, announced on Oct. 4, 2022 that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its melatonin 1mg/mL oral solution for sleep onset insomnia in children and adolescents aged 6–17 years with attention-deficit hyperactivity disorder (ADHD).

According to a company press release, melatonin has the potential to decrease sleep latency and increase sleep efficiency in children with ADHD and chronic sleep onset insomnia. Children with ADHD are statistically more likely to have sleep onset insomnia than non-ADHD children. The prevalence of sleep onset insomnia in children with ADHD ranges from 25–50% and can affect their mood, attention, behavior, and school performance.

“We welcome the MHRA’s approval for a condition that negatively affects the quality of life for children and adolescents diagnosed with ADHD and increases the burden for support networks,” said Henno Welgemoed, director of medical affairs at Colonis, in the release. “This approval provides a valuable treatment option for children and adolescents suffering with ADHD and sleep onset insomnia, adding further breadth to Colonis’ growing pediatric portfolio while supporting Clinigen Group’s mission to deliver the right medicine to the right patient at the right time.”

The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.

UK Approves Treatment for Sleep Onset Insomnia in Children and Adolescents

H.I.G. Capital, a global alternative investment firm, announced on Oct. 3, 2022 that its portfolio company Aspire Pharma has acquired Morningside Healthcare and Morningside Pharmaceuticals, a UK provider of niche generic and branded specialty pharmaceuticals. The financial terms of the transaction have not been disclosed.

Morningside is focused on developing and licensing niche generic pharmaceutical products, marketing over 160 stock keeping units across more than 80 product families and multiple therapeutic areas. According to a company press release, H.I.G. is combining Morningside with Aspire Pharma to build growth, product development, and support new initiatives, such as international expansion.

“We are excited to welcome the Morningside team to the Aspire family,” said Richard Condon, CEO of Aspire, in the release. “This is a transformative opportunity for both companies to expand and enhance our market position as a result of both companies highly complementary product portfolios. The combination will create one of the largest and fastest growing UK pharma companies and see further accelerated growth potential in our current and future product portfolio, in the UK and internationally.”

H.I.G. Capital’s portfolio company Aspire Pharma has acquired Morningside Healthcare and Morningside Pharmaceuticals.

H.I.G. Capital Acquires Morningside Healthcare and Morningside Pharmaceuticals

Ashland announced the introduction of Klucel xtend hydroxypropyl cellulose (HPC) controlled release matrix former on Oct. 3, 2022. It is designed to deliver process versatility and release profile efficiency.

According to a company press release, Klucel xtend HPC has been shown to match the release profile of widely used Hypromellose controlled-release formulations at half the polymer concentration. Prior to this product launch, Ashland claims that there were limited options for managing the release profile of controlled release formulations, especially high dose. 

The reduced polymer concentration offers the possibility of smaller pills or higher dosage, presenting an option for easier tablet swallowability or a reduction in the number of tablets required for frequent medication. According to the release, this feature is intended to improve patient compliance with drug regimens.

Klucel xtend HPC is the latest addition to the company’s Klucel product line and further expands their controlled-release portfolio.