Grant Playter

Thermo Fisher Scientific announced the launch of the Gibco OncePro Tumoroid Culture Medium Kit on June 28, 2023. According to a company press release, the kit is the first commercially available culture medium specifically developed for the expansion of patient-derived tumoroids, or cancer organoids, from multiple cancer indications. In an effort to improve ease of use, the kit includes a scalable, automation-compatible suspension culture method.

According to the release, patient-derived tumoroids hold promise in helping improve clinical trial success rates for cancer researchers seeking to better model disease and predict patient response to therapeutics 

; however, their use has been limited due to challenging cell culture requirements and a lack of commercially available media systems, according to the company in the release. The off-the-shelf modular tumoroid culture medium kit is designed to fill this perceived gap in the market.

“Cancer’s unpredictable nature presents a significant scientific and clinical challenge for future discoveries and in delivering life-saving treatments to patients,” said Brian Douglass, vice-president and general manager, Cell Biology, Thermo Fisher Scientific, in the release. “Globally, millions of patients and their families still await a cure for cancer despite the decades of advances in research, diagnostics, and treatments aimed at helping lower cancer mortality. We developed the new OncoPro Tumoroid Culture Medium Kit so the scientific community can take greater advantage of tumoroid models to help bring drug candidates to market faster and more cost-effectively.”

“It is well known that tumor organoids are more predictive of clinical outcomes, adverse events and resistance mechanisms than established 2D cell line counterparts,” said Erik Goka, vice-president, Biology, Revere Pharmaceuticals, in the release. “The OncoPro Tumoroid Culture Medium Kit allows us to seamlessly integrate tumoroids into our research and drug discovery processes. With the tumoroid media system, we can propagate all our organoid models in the same culture medium system irrespective of the tissue of origin. This media system has been instrumental in allowing us to bring tumor organoids into our lab for everyday use.”

In addition to the kit, Thermo Fisher Scientific offers services in tumoroid assay development to support outsourced screening and characterization. Customers may also access seven unique OncoProtumoroid cell lines, representing four different cancer indications including colorectal, lung, endometrial, and breast.

Articles

Thermo Fisher Scientific’s new tumoroid culture medium kit is designed to help cancer researchers better model the disease.

Thermo Fisher Scientific Releases Tumoroid Culture Medium Kit 

Eurofins Genomics Blue Heron, a biotechnology company specializing in advanced gene synthesis, announced the launch of its in-vitro transcription (IVT) messenger RNA (mRNA) synthesis service on June 29, 2023. According to a company press release, the new synthesis service is designed to offer a comprehensive solution for researchers seeking high-quality, customizable mRNA synthesis with fast turnaround times.

According to the release, the new synthesis service is equipped to handle various applications and includes customizable mRNA synthesis capabilities to meet specific research needs. It is designed for use in molecular biology, drug discovery, vaccine development, and gene therapy, among other fields.

Eurofins Genomics Blue Heron’s novel mRNA synthesis service is designed for customizable applications.

Eurofins Genomics Blue Heron Launches In-Vitro Transcription mRNA Synthesis Service 

The topic of “innovation” is an ephemeral, shapeshifting beast. While today the industry envisions concepts such as personalized vaccines or oral biologics, 10 years from now pharmaceutical leaders will have surely moved on to even bigger, brighter, and more compelling technologies. 

However, it is because of this continual evolution that innovation, as a concept, holds a sanctified status for members of the pharmaceutical industry. Consequently, any perceived diminution will be challenged with immediate furor. For instance, the 

, who’s price controls have received significant pushback from venture capitalists (1), has now resulted in Merck, known as MSD outside of the United States and Canada, suing the US federal government (2). Similarly, in the Amgen v. Sanofi Supreme Court case, which tested whether broad genus claims were legally permissible (3), both companies’ arguments centered around stifling innovation—just at different steps of the pharma lifecycle. 

I question to what end “stifling innovation” can serve as an effective argument when it can seemingly be applied anywhere, to any situation, without constraint. If any proposed rule change stifles innovation, then the industry’s structure will remain status quo; however, isn’t maintaining the status quo itself antithetical to the core ethos of innovation, indeed to that of the very concept of progress itself? Innovation is crucial, and strong efforts to protect it should be made. We should not conflate innovation with simple “change.” However, if we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal: real progress. 

1. Playter, G. The United States and the Global BioPharma Market. 

2. Merck. The Inflation Reduction Act’s Negative Impact on Patient-Focused Innovation, Value and Access. 

3. Wingrove, P. Amgen-Sanofi Patent Case Divides Makers of Antibody Drugs. 

When referring to this article, please cite it as Playter, G. Innovation Idolotry. 

If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.

Innovation Idolatry

Donaldson Company, a US-based provider of filtration products and solutions, announced its acquisition of Univercells Technologies, a Belgian biotechnology company specializing in biomanufacturing solutions for cell and gene therapy research, development, and commercial manufacturing, on June 29, 2023. According to a company press release, Donaldson acquired Univercells for €136 million (US$148 million) on a cash-free, debt-free basis.

Univercells’ current product line includes the scale-X single-use structured fixed-bed bioreactor, which is designed for the intensified production of viruses for use in cell and gene therapies, viral vaccines, and various other therapeutics. The company also has the automated NevoLine upstream platform, which uses industry-standard filtration to provide integrated up- and mid-stream processing capabilities.

“The acquisition of Univercells Technologies represents an important next step in Donaldson’s life sciences strategy, as we continue to expand our product portfolio aimed at providing customers with a comprehensive, differentiated offering,” said Tod Carpenter, chairman, president, and CEO, Donaldson, in the release. “Univercells Technologies’ engineered systems provide close adjacencies with our previous life sciences acquisitions as well as with our growing organic product suite.”

“We are extremely excited to join Donaldson as we grow our portfolio of ... biomanufacturing platforms and increase our market penetration and related installed base of equipment," said Mathias Garny, CEO, Univercells Technologies, in the release. “Our technology, complemented by Donaldson’s filtration excellence and existing life sciences capabilities is part of a larger vision to bring end-to-end solutions to market for advanced therapies.”

Donaldson Company’s €136 million (US$148 million) acquisition of Univercells is designed to broaden its portfolio of biomanufacturing solutions.

Donaldson Company Acquires Univercells Technologies for €136 Million 

In this video interview, Mason Ailstock, CEO of the Rowen Foundation, talked to Grant Playter, associate editor, on the topic of incubators and their potential to promote innovation. 

Rowen is a knowledge community in Metro Atlanta focused on fostering collaboration across industries, including those in the medical, environmental, and agricultural fields. In this interview, Mason touches on the current status of the Rowen Foundation, the importance of fostering collaboration in this manner, and how it can promote innovation in the biopharma industry.

Videos

Mason Ailstock, CEO of the Rowen Foundation, discusses incubators and their potential to promote innovation.

Investigating Incubators & Innovation with Mason Ailstock

FDA announced approval of Rystiggo (rozanolixizumab-noli) as a treatment for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive on June 27, 2023. Rozanolixizumab-noli is a subcutaneous administered, humanized monoclonal antibody injection designed to accelerate the catabolism of antibodies and reduce the concentration of pathogenic immunoglobulin G (IgG) autoantibodies. The approval was granted to Union Chimique Belge (UCB), a Belgian biopharmaceuticals company.

According to a UCB press release, gMG is a rare, chronic, autoimmune disease characterized by dysfunction and damage at the neuromuscular junction (NMJ). Pathogenic IgG autoantibodies can impair synaptic transmission at the NMJ by targeting specific proteins on the post-synaptic membrane, disrupting the ability of nerves to stimulate the muscle; this ultimately results in weaker muscle contractions.

FDA approval was based on data from the Phase III MycarinG study, whose primary efficacy endpoint was comparison of the change from baseline between treatment groups in the MG-ADL total score, a measurement tool which assesses the impact of gMG on daily functions, at Day 43. A statistically significant difference favoring rozanolixizumab-noli over placebo (-3.4 to -0.8) was observed in the MG-ADL total score change from baseline.

“No two people living with gMG experience the disease in the same way, so we can’t take a ‘one size fits all’ approach to disease management,” said Iris Loew-Friedrich, executive vice-president and chief medical officer, UCB, in the press release. “Disease management should be based on the clinical needs and preferences of the individual patient, and the aim of treatment is to help restore that patient’s ability to carry out activities of daily living. The approval of rozanolixizumab-noli means doctors have an additional approved treatment option for their gMG patients who have not yet found a treatment that meets their needs.”

FDA reviewed rozanolixizumab-noli under the priority review indication. The treatment is also currently being evaluated by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.