Grant Playter

ChargePoint Technology, a company specializing in powder transfer, and Famat Sampling, a company specializing in sampling devices, announced a collaboration technology on May 16, 2023. According to a company press release, the companies’ new integrated valve solution allows operators to take a product sample for quality analysis during the course of production while maintaining optimal containment and sterile integrity.

The new product, a combination of ChargePoint’s split butterfly valve and Famat’s 125-Threaded Cap/Occupational Exposure Limit valve, is designed to create a secure and sterile environment for high-potency and sterile powder samples to be taken. According to the release, the interconnected system forms an airtight seal that prevents a dead zone and allows for sampling of highly potent, toxic, or sterile powders to be transferred while maintaining Occupational Exposure Band 4 (OEB4) and OEB5 level compliance.

“During processing, manufacturers must prioritize sampling so that the quality of drug products can be assessed at various stages of the production process,” said Christian Dunne, head of Sterile Solutions, ChargePoint Technology, in the release. “Famat Sampling shares our high standards for quality. Joining forces as two recognized industry leaders in our respective fields was a no-brainer for our team.”

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ChargePoint Technology and Famat Sampling’s combination technology is designed to allow for product sampling during the course of production.

ChargePoint Technology and Famat Sampling Collaborate on Novel Sampling Technology

Sony, a wholly owned subsidiary of Sony Group, which handles entertainment, technology, and services, and Astellas Pharma announced a collaborative research agreement on May 16, 2023. Under the agreement, the companies will work to discover a novel antibody-drug conjugate (ADC) platform in oncology based on Sony’s “KIRAVIA Backbone” organic polymer.

According to a company press release, both companies will jointly develop and optimize a new ADC platform using Sony’s organic polymer as a linker. Additionally, Astellas will conduct non-clinical trials of development candidates. The companies also indicated that they are continuing discussions to expand research partnerships on non-ADC drug discovery platforms.

"Sony's life science business has accumulated substantial knowledge in the field of cell analysis," said Katsunori Ogawa, head of Life Science & Technology Business Unit, Sony, in the release. "Through this collaboration, Sony is striving to contribute to the medical and drug discovery fields and provide further social value by leveraging Sony's technological capabilities in the development of anti-cancer drugs therapy, which are expected to grow."

"We are pleased to enter into a joint research agreement with Sony," said Yoshitsugu Shitaka, chief scientific officer, Astellas Pharma, in the release. "Astellas is working to create innovative drugs from a multifaceted perspective called the Focus Area approach, which identifies combinations of biology, therapeutic modality or technology, and diseases with high unmet medical needs. The partnership will further strengthen our ability to utilize suitable modalities. It is our expectation that the collaboration will lead to the continuous creation of innovative drugs for patients around the world."

Astellas and Sony will collaborate to discover a novel ADC platform for use in oncology.

Astellas and Sony Enter ADC Platform Collaboration

The Federal Trade Commission (FTC) announced on May 16, 2023 that the agency is filing suit against Amgen in conjunction with Amgen’s recent $27.8 billion bid to acquire Horizon Therapeutics. In an agency press release, FTC cited concerns that the acquisition would enable Amgen to use rebates on its existing blockbuster drugs to pressure insurance companies and pharmacy benefit managers into favoring Horizon’s two-monopoly biologics products. The biologics products in question are Tepezza (teprotumumab-trbw), a treatment for thyroid eye disease, and Krystexxa (pegloticase), a treatment for chronic refractory gout.

“Rampant consolidation in the pharmaceutical industry has given powerful companies a pass to exorbitantly hike prescription drug prices, deny patients access to more affordable generics, and hamstring innovation in life-saving markets,” said Holly Vedova, Bureau of Competition director , FTC, in the release. “Today’s action—the FTC’s first challenge to a pharmaceutical merger in recent memory—sends a clear signal to the market: the FTC won't hesitate to challenge mergers that enable pharmaceutical conglomerates to entrench their monopolies at the expense of consumers and fair competition.”

In response to the suit, Amgen released a public statement denying its intentions to bundle coverages.

“The medicines offered by Amgen and Horizon generally treat different diseases and patient populations, and there are no overlaps of competitive concern,” reads the statement. “The FTC's claim that Amgen might ‘bundle’ these medicines (offer a multi-product discount) at some point in the future is entirely speculative and does not reflect the real-world competitive dynamics behind providing rare-disease medicines to patients.”

Amgen’s statement also questioned whether any acquisition could be denied under a “bundling theory,” claiming that there was no such precedent.The company also announced its intent to work with the courts and complete the acquisition by mid-December 2023.

In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.

FTC Sues to Block Amgen’s $27.8 Billion Acquisition of Horizon Therapeutics

The National Science Foundation (NSF) awarded The Puerto Rico Science, Technology & Research Trust (Trust) $1 million as part of NSF’s Regional Innovation Engines program. The Trust is one of 44 unique teams to receive the first-ever NSF Engines Development Awards, which aims to help partners collaborate on economic, societal, and technological opportunities for significant growth in their regions. Bright Path Laboratories, a US-based advanced drug development and manufacturing company, will participate as a collaborator in this award.

According to a company press release, the “Advancing Biopharmaceutical Technologies and Manufacturing Practices (P.R.)” award aims to lay the groundwork for establishing a NSF Regional Innovation Engine in Puerto Rico. This includes developing its structure and scope, as well as establishing partnerships to advance biopharmaceutical technologies and manufacturing practices. If sufficient progress is made after two years, the Trust will be eligible for an NSF Engines Award of up to $160 million for up to 10 years.

“The necessity to invest in innovative pharmaceutical manufacturing in the United States has never been greater. Bright Path’s … continuous flow advanced manufacturing platform is an integral part of our nation’s supply chain readiness initiative,” said Tony Quinones, co-founder and CEO, Bright Path Laboratories, in the release. “We are very pleased that NSF has chosen the Trust as an awardee and excited to expand and solve the immediate and long-term challenges in our medicinal supply chain through our transformative technology.”

The NSF-sponsored program aims to help partners collaborate to create opportunities for significant economic, societal, and technological opportunities for growth in their regions.

Bright Path Laboratories to Collaborate in NSF Engines Development Program

Data from a Phase I clinical trial of BioNTech and Roche’s personalized cancer vaccine candidate, adjuvant autogene cevumeran, was published in 

 on May 10, 2023. The study evaluated the vaccine’s ability to fight pancreatic ductal adenocarcinoma (PDAC), an aggressive form of pancreatic cancer that the study noted is the third leading cause of death from cancer in the United States and lethal in approximately 88% of patients.

The treatment is an individualized neoantigen vaccine based on uridine messenger RNA (mRNA)–lipoplex nanoparticles, which was developed using mRNA neoantigen vaccines in real time from surgically resected PDAC tumors. When treated with adjuvant autogene cevumeran, in combination with atezolizumab and mFOLFIRINOX, eight of the 16 patients developed T cells that could potentially fight PDAC. Vaccine-expanded T cells were durable, persisting up to two years after injection.

“High-magnitude vaccine-induced T-cell responses, the focus of our immune response analysis that included a new method to track vaccine-expanded clones, correlated with delayed PDAC recurrence,” reads the study. “Despite the limited sample size, these early results warrant larger studies of individualized mRNA neoantigen vaccines in PDAC.”

The data, published in the scientific journal Nature, demonstrated that half of patients developed T cells that could potentially fight pancreatic ductal adenocarcinoma.

BioNTech and Roche Publish Personalized Vaccine Data

Agilent released an announcement of its Agilent 8697 Headspace Sampler -XL Tray, which features 120-vial capacity, in addition to their existing 48-vial capacity tray. In addition to the capacity increase, the new tray includes new instrument intelligence features that are designed for increased uptime and operator ease-of-use relative to its predecessor.

According to a press release from May 1, 2023, the device’s intelligence features are enabled through self-monitoring operations and guiding operators that use various troubleshooting and maintenance procedures. The system performs automated system checks, including leak checks, early maintenance feedback, and self-diagnostics. Additionally, the new tray can be run with alternate carrier gasses due to the separation of vial pressurization and the sample loop for added method flexibility.

“Labs that run headspace GC [gas chromatography] systems know that if they encounter problems during a sequence, and the vials are punctured, they may have to rerun or recollect samples,” said Mike Zhang, vice-president and general manager of Agilent’s Gas Phase Separations Division. “The 8697 and now the 8697 Headspace Sampler-XL Tray virtually eliminate that problem. The complete GC headspace system checks to ensure that the system and data quality are up to SOP [standard operating procedure] standards, avoiding recollection of samples and reruns.”

The Agilent 8697 Headspace Sampler-XL Tray has a 120-vial capacity.