Pharmaceutical Technology Editors

Medigene AG, an immuno-oncology company focused on the development of differentiated, T Cell Receptor engineered T cell (TCR-T) therapies, announced on Jan. 18, 2023, that it has received a $3 million payment from partner 2seventy bio as a part of its T cell receptor agreement in cancer immunotherapy, which may lead to further historical payments in the future.

This payment comes after the strategic alliance between 2seventy bio and JW Therapeutics with a focus on the development of 2seventy bio’s MAGE-A4 program, which services a highly potent TCR discovered in collaboration with Medigene’s proprietary end-to-end technology platform.

Recently, 2seventy bio announced the initiation of a strategic partnership with JW Therapeutics aiming at the collaboration being the development of 2seventy bio’s MAGE-A4 cell therapy in mainland China, Hong Kong, and Macao.

“We are delighted that Medigene’s partnership with 2seventy bio has led to the progress of cell therapies in China through 2seventy bio’s strategic alliance with JW Therapeutics,” said Selwyn Ho, PhD, chief executive officer of Medigene, in a press release. “This alliance, and recent milestone payment to Medigene, further validate our end-to-end technology platform and its potential to deliver differentiated, best-in-class TCRs. We look forward to the commencement of the MAGE A-4 TCR program in mainland China, Hong Kong, and Macao, and the benefits this could mean for patients.”

“We are excited about the ability to accelerate the development of the MAGE-A4 program; made possible in part by the important contributions of our collaboration with Medigene,” said Steve Bernstein, chief medical officer of 2seventy bio, in a press release. “This is a powerful program, supported by our collective areas of expertise and designed to create potentially transformative treatments for patients with solid tumors.”

This recent payment does not alter guidance on the cash runway of Medigene, which is based on current planning into Q4 2024.

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Medigene Receives Historic $3 Million Payment from 2seventy Bio

Cambrex, a global contract development and manufacturing organization (CDMO) providing drug substance, drug product, and analytical services, announced on Jan. 18 2023 that it has acquired Snapdragon Chemistry, a US-based provider of chemical process development services to a broad range of emerging and established biopharma customers.

“Today, we welcome our new colleagues from Snapdragon to Cambrex,” said Tom Loewald, CEO of Cambrex, in a press release. “With Snapdragon’s depth of scientific expertise in API process development, I’m certain our customers will see the benefits of this combination and be delighted to work with Snapdragon’s team.”

“I am extremely proud of what our team at Snapdragon has built over the years,” said Matt Bio, CEO of Snapdragon, in a press release. “With Cambrex, we have found an ideal home for our customers and employees, and I look forward to continued success as part of Cambrex.”

Snapdragon Chemistry concentrates in API batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges.

Cambrex is aiming to expand its portfolio of specialized solutions for pharmaceutical development and manufacturing, especially with Snapdragon’s expertise in continuous flow manufacturing and complementing recent investments in continuous flow process development capabilities.

Cambrex Acquires Snapdragon Chemistry

Agilent Technologies announced a $725 million investment in nucleic acid-based therapeutics on Jan. 9, 2022. Therapeutic nucleic acids, also known as therapeutic oligonucleotides or oligos, are short DNA and RNA molecules that serve as the active pharmaceutical ingredient (API) for various drugs. The investment will be used to double manufacturing capacity to produce APIs.

According to a company press release, the investment will add two new manufacturing lines (Trains C and D) to Agilent’s Frederick, Colo., facility. The expanded facility will employ advanced automation and engineering enhancements such as water reduction and solvent capturing and recycling. Customer shipments from the expansion are expected to begin in 2026.

“One of our strategic priorities is to help existing and new biopharma customers develop, globally commercialize, and accelerate growth of oligo-based therapeutics,” said Sam Raha, president, Diagnostics and Genomics Group, Agilent, in the release. “This additional capacity will enable us to meet strong demand for siRNA [small interfering RNA] and antisense molecules and also significantly increase the number of CRISPR [clustered regularly interspaced short palindromic repeats] guide RNA programs we can take on.”

Agilent’s $725 million investment is designed to double its capacity to produce APIs.

Agilent Invests $725 Million in Nucleic Acid-based Therapeutics

Nova Biomedical, a life sciences instrument provider, recently announced the launch of the BioProfile FAST CDV, a high-throughput, fully automated viable cell density and viability analyzer. The device uses trypan blue dye exclusion methodology for determination of live and dead cells, as well a high-resolution camera/optics to provide cell density and cell viability measurements.

According to a press release from Jan. 3, 2023, the analyzer is capable of producing results in less than 70 seconds with 100 microliters of sample volume. It also performs all sample dilutions internally, which allows cell culture samples up to 140e⁶ c/mL to be analyzed without external sample dilution. The device can sample cell cultures via an external 36-position loans-and-go tray or via a 96-well plate option.

The software associated with the device has a built-in touch screen display and icon-based navigation. Its software and networking capabilities are 

 compliant and have also been designed to meet FDA’s new cybersecurity guidelines.

“We at Nova Biomedical are excited to launch the next addition to the BioProfile platform with the FAST CDV Analyzer,” said Matt McRae, Biotechnology Sales Product line manager, Nova, in the release. “The FAST CDV is a significant advance in automated cell density analyzers and breaks the boundaries of existing technologies. It will enable even faster evaluation of cell lines and physicochemical parameter optimization, ultimately bringing products to market faster.”

The BioProfile FAST CDV is a fully automated viable cell density and viability analyzer.

Nova Biomedical Launches Cell Density and Viability Analyzer

Vetter announced on Jan. 18, 2023 that it had achieved gold status in the EcoVadis sustainability ranking, with 72 points out of a maximum of 100. This makes the company among the top 5% of all participating companies in the industry. The new ranking adds to the company’s commitment to implementing improvements in the rating criteria of Environment, Labor & Human Rights, Ethics, and Sustainable Procurement.

"We are very proud that our far-reaching initiatives in many areas around sustainable corporate governance have had a significant impact on the EcoVadis rating, and that we were, once again, able to demonstrate improvement over previous years. The positive external evaluation is a strong achievement and further motivates us to continue this great development in a transparent manner among our employees, customers, and partners, as well as the patients and society," said Peter Soelkner, managing director at Vetter.

"Simply talking about this topic is never enough in our opinion," added Thomas Otto, managing director at Vetter. "With our activities involving social, economic and ecological sustainability, we want to have a positive impact on the regions with our sites."

Vetter significantly increases its sustainability ranking by achieving gold status in EcoVadis ranking. 

Vetter Wins Gold in EcoVadis Ranking

Pfizer and Gero, a Singapore-based preclinical-stage physics-enabled biotechnology company, have entered into a research collaboration in which Pfizer will apply Gero’s machine learning technology platform to discover potential therapeutic targets for fibrotic diseases. The collaboration will use large-scale human-based data.

Under the agreement, Gero will receive an upfront payment. The company is also eligible to receive discovery milestone payments if the project progresses. The collaboration will leverage Pfizer's expertise and Gero’s technology platform to identify genes and pathways that are linked to fibrotic diseases. Pfizer may advance the potential therapeutic targets and would be responsible for any further preclinical and clinical development.

“Human data-driven drug discovery avoids the ‘preclinical trap’ and has the potential to identify clinically relevant targets against human (not rodent) diseases. However, genetics-based target identification against age-related diseases is hindered by the irreversible component of human aging,” said Peter Fedichev, CEO of Gero, in a Jan.6, 2023 company press release. “Our technology platform allows us to separate irreversible effects of aging from reversible disease phenotypes to potentially identify the most actionable therapeutic targets.”

“We are excited to work with Pfizer … to potentially identify targets against fibrotic diseases, which have a large unmet need. We believe that combining our platform technology with Pfizer’s extensive disease expertise has the potential to identify high-value targets in this disease area,” said Alex Kadet, chief business officer, Gero, in the release.

Pfizer and Gero have partnered to discover potential therapeutic targets for fibrotic diseases using machine learning technology.