Pharmaceutical Technology Editors

Merck, known as MSD outside the United States and Canada, launched its Merck Digital Sciences Studio (MDSS) in June 2022, which is aimed at enabling the generation of innovative technologies for drug discovery and development.

The objective of MDSS is to support early-stage biomedical startups with direct investment, access to Azure Cloud computing, and opportunities to pilot their respective technologies in collaboration with discovery and clinical scientists at Merck. Merck opened applications on its website for 12 spots for the first MDSS cohort, and applications for startups developing artificial intelligence (AI) and machine learning (ML) will be prioritized, according to a June 29, 2022 company press release. The program currently plans to include six startups at each of MDSS’ Newark, NJ, and Cambridge, Mass., venues.

The MDSS is a collaboration between Merck and the New Jersey Innovation Institute (NJII), a New Jersey Institute of Technology corporation. Investments have come from the Merck Global Health Innovation Fund, Northpond Ventures, and McKesson Ventures. In addition, Microsoft for Startups will provide technology support, including Microsoft 365 and Azure, as well as provide expert business advice and technical support.

Digital technologies have enabled the innovation of biomarkers for use in drug discovery and development, specifically in the areas of target identification, lead discovery, preclinical development, and clinical development. MDSS will allow collaborators to selectively accelerate and pilot novel and innovative digital technologies that strategically align with Merck’s life science research.

“The biopharmaceutical industry has only just started to harness the tremendous opportunity presented by emerging technological developments in AI and ML,” said Fiona Marshall, senior vice-president, Discovery, Preclinical, and Translational Medicine, Merck Research Laboratories, in the company press release. “The MDSS will provide a collaborative and entrepreneurial setting where scientists have access to the tools and expertise to fuel important innovations that advance drug discovery and development.”

“Startups in the biopharmaceutical industry fuel innovation, create high-quality jobs and generate great opportunities for a stronger, more diverse and inclusive life-sciences ecosystem,” said Simon Nynens, CEO, NJII, in the release. “NJII looks forward to providing the programming, coaching, and connections to bring these ideas to life.”

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Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.

Merck Digital Sciences Studio Supports Early-Stage Startups

Touchlight, a biotechnology company specializing in enzymatic DNA production, entered into a non-exclusive patent license agreement with Pfizer on July 6, 2022. Under the agreement, Pfizer gains rights to Touchlight’s enzymatic doggybone DNA (dbDNA) patent portfolio. Pfizer will have rights to use dbDNA worldwide for the manufacture and commercialization of its messenger RNA (mRNA)-based vaccines, therapeutics, and gene therapies.

Through the agreement, Touchlight will receive an upfront payment as well as clinical and commercial milestone payments and royalties upon commercialization. The financial terms of the deal were not disclosed.

Touchlight’s dbDNA technology has been shown to produce a minimal, linear, double stranded, covalently closed DNA vector via an enzymatic manufacturing process. dbDNA enables the rapid, synthetic manufacture of good manufacturing practice (GMP)-compliant DNA product from a small, simple footprint. Furthermore, it is a scalable GMP manufacturing process.

The technology can manufacture genes >20 kb. It also has the added advantage of being able to accommodate sequences typically unstable as plasmid DNA in 

; these include sequences found in viral vector and mRNA production. Beyond mRNA vaccine production, the technology is suited for the development of DNA vaccines, advanced therapies, and other therapeutics, according to a company press release.

“We are delighted to establish this agreement with Pfizer to license our mRNA manufacturing platform. This agreement is an example of our technology’s potential to enable companies across the genetic medicine sector to simplify and accelerate DNA manufacturing through the clinic and towards commercialization,” said Jonny Ohlson, founder and executive chair, Touchlight, in the press release.

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

Pfizer and Touchlight Enter Patent License Agreement for Use of dbDNA

Wacker Biotech, a microbial contract development and manufacturing organization within the Wacker Group, announced on July 5, 2022, that it has begun the development of its biotech site in Halle, Germany, into a messenger RNA (mRNA) competence center. Moving forward, active drug substances based on mRNA, such as mRNA coronavirus vaccines, will be manufactured at this site.

Wacker is investing more than €100 million (US$100.5 million) into this expansion, which will triple production capacity and more than double the number of employees at the Halle site, according to a company press release.

The expansion will include four new production lines for mRNA vaccine production, among other products. Under pandemic preparedness contracts, part of the new capacity at Halle will be made available to the German federal government as and when required. The expansion will also include new storage areas and quality control laboratories. The company intends to hire around 200 new employees as part of the expansion. Production is expected to start in 2024.

“We are happy that our expertise in making mRNA vaccines will contribute to the fight against future pandemics. The expansion of our Halle site will create capacity to prepare for pandemics and beyond,” said Christian Hartel, CEO, Wacker, in the press release.

“With this expansion into a competence center for mRNA actives, W[acker] is bringing a technology of the future to Halle,” said Melanie Käsmarker, managing director of Wacker Biotech in Halle, in the release. “mRNA actives are not only used as vaccines, for example to protect against coronavirus, but the mRNA technology also allows completely new treatment options, such as in cancer therapy. We see a lot of potential here and going forward want to serve the increasing demand for mRNA actives from Halle.”

Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.

Wacker Biotech Expands Germany Site with Construction of New mRNA Competence Center

Coya Therapeutics, a clinical-stage biotechnology company, secured an option agreement in June 2022 for exclusive worldwide rights to a novel technology platform from Carnegie Mellon University. The technology platform enables exosome engineering.

The agreement will grant Coya intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids (EPHs), according to a June 15, 2022 press release. The company will use a tether-based exosome strategy that enables regulatory T-cells (Tregs) exosomes to be homed to proteins of interest while delivering select payloads into the targeted cells.

According to the release, the use of EPHs differs from traditional techniques that modify exosomes via complex molecular biology tools or degradation of exosomes' innate functionality; EPHs overcome these limitations by modifying exosomes with a DNA-cholesterol tether. By leveraging single stranded synthetic DNA with attached cholesterol, this approach binds a complementary strand of DNA to a bioactive agent. Ultimately, this allows a number of different types of cargos to be attached to the exosome surface while also tethering immune modulating cargos inside the exosome.

“This collaboration with Carnegie Mellon University further solidifies Coya’s thought leadership in the global exosome therapeutics field, beyond Treg-derived exosomes alone,” said Howard Berman, CEO, Coya Therapeutics, in the press release. “Nanoengineering exosomes with such manufacturing efficiency to produce EPHs that can be customized to any surface protein, delivering growth factors or drugs, while enhancing cellular uptake and bioactivity is the future of targeted therapies.”

Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.

Coya Therapeutics Secures Rights to Exosome Engineering Technology from Carnegie Mellon University

Bio-Rad Laboratories has launched its EconoFit Low-Pressure Prepacked Chromatography Column Packs. The EconoFit columns are designed for resin screening, allowing customers that are developing protein purification workflows to select the optimal chemistry for different targets.

The columns offer various resins in a prepacked format, including mixed-mode, cation, and anion exchange resin columns, as well as a pack designed for polyhistidine protein purification. According to a June 28, 2022 press release, they are fully compatible with Bio-Rad’s next-generation chromatography systems in addition to other commonly used chromatography systems. The columns are available in 1 mL and 5 mL sizes.

“Similar resins can give different results for different target molecules, and with Bio-Rad’s EconoFit Column Packs our customers can easily perform resin scouting to identify the one [that] yields the best outcome for their chromatography application,” said Ertan Ozyamak, global product manager for lab-scale chromatography products, Bio-Rad, in the press release. “Our columns deliver run-to-run uniformity to support preparative scale purifications and/or method development for new target proteins, as well as to improve existing workflows.”

Bio-Rad’s EconoFit Chromatography Column Packs support resin screening experiments in the development of protein purification workflows.

Bio-Rad Launches New Chromatography Column Packs

VeriSIM Life (VeriSIM), a US-based artificial intelligence (AI)-enabled company that provides drug discovery and drug development services, has entered into a collaboration with Mayo Clinic to improve the preclinical translation of promising drug candidates for development.

Under the agreement, VeriSIM will use its proprietary BIOiSIM platform and Translational Index technology to reduce the number of outsourced preclinical experiments. These platforms are also expected to help de-risk R&D decisions early on to ensure expedited development of novel, safe, and highly efficacious drugs, according to a June 28, 2022 company press release. Mayo Clinic physician researchers will work with VeriSIM in key disease areas, including oncology, hematology, bone/joint-disorders, and neurological diseases.

“This collaboration will explore the full potential of our combined approach to developing best-in-class drug candidates to serve patients’ unmet needs,” said Jo Varshney, founder and CEO of VeriSIM Life, in the press release.

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.