Feliza Mirasol is the science editor for 

Feliza Mirasol

On Dec. 5, 2023, MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt Germany, launched AIDDISON, a drug discovery software touted as the first software-as-a-service platform. The platform aims to bridge the gap between virtual molecule design and real-world manufacturability using Synthia retrosynthesis software application programing interface (API) integration.

The platform combines generative artificial intelligence (AI), machine learning, and computer-aided drug-design designed to speed up drug development. The AIDDISON software is trained on more than two decades of experimentally validated datasets from pharmaceutical R&D, and, as a result, it can identify compounds from more than 60 billion possibilities having the key properties of a successful drug: non-toxicity, solubility, and stability in the body, according to a company press release. Upon identification, the platform then proposes ways to best synthesize these drugs.

According to MilliporeSigma, AI and machine learning models such as its AIDDISON software can extract hidden insights from large datasets. In doing so, these models can increase the success rate of delivering new therapies to patients. “AI has the potential to offer more than $70 billion in savings for the drug discovery process by 2028, and to save up to 70% time and costs for drug discovery in pharmaceutical companies,” the company stated in its press release.

“With millions of people waiting for the approval of new medicines, bringing a drug to market still takes, on average, more than 10 years and costs over $2 billion,” said Karen Madden, chief technology officer, Life Science business sector of Merck, in the press release. “Our platform enables any laboratory to count on generative AI to identify the most suitable drug-like candidates in a vast chemical space. This helps ensure the optimal chemical synthesis route for development of a target molecule in the most sustainable way possible.”

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MilliporeSigma’s new platform combines generative AI, machine learning, and computer-aided drug-design aimed at increasing the success rate of new drugs and therapies.

MilliporeSigma Launches AI Solution for Integrating Drug Discovery and Molecule Synthesis

On Nov. 24, 2023, Novartis issued a voluntary nationwide recall at the consumer level in the United States of two lots of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to the formation of crystals, which was observed in some bottles. Crystallization could potentially result in incorrect dosing.

The crystallization issue was identified during an investigation of crystallization in a different lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. According to a company statement, no other Sandimmune formulations are impacted.

The product, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It may also be used to treat chronic rejection in patients previously treated with other immunosuppressive agents.

The company released the following risk statement: “Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues. Novartis has not received any reports of adverse events related to this recall, to date.”

The lot numbers and expiration dates affected by this recall are: FX001500 (expiration date 09/2024) and FX001582 (expiration date 09/2024) NDC 0078-0110-22. The company has stated that these lots were only distributed in the US and that they were distributed nationwide to wholesalers across the country starting in January 2022 and September 2022, respectively.

The company is notifying distributors by letter and is arranging the return of the recalled lots from distributors, retailers, and consumers. Novartis is also notifying health care providers to contact patients who have been prescribed this medication. Consumers who obtained bottles from the affected lots should contact their individual health care provider.

In the event of an adverse reaction or quality problem involving this product, patients are encouraged to immediately contact their health care provider and Novartis to report the event or finding. Patients or health care providers can contact the Novartis customer interaction center at 888-NOW-NOVA (888-669-6682) or may report an adverse event through https://www.novartis.com/report or usdrugsafety.operations@novartis.com.

In addition, adverse reactions or quality problems experienced with this product can be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

. For regular mail, download the form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, which should be completed and returned to the address on the pre-addressed form. If reporting by fax, submit to fax number 1-800-FDA-0178.

Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.

Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL

Novo Nordisk announced on Nov. 23, 2023 that it will invest more than DKK 16 billion (US$2.3 billion), starting in 2023, to expand its existing production site in Chartres, France. The company plans to significantly increase the capacity of the manufacturing site by adding aseptic production and finished production processes, as well as an extension of the site’s current laboratory for quality control.

With the expanded facilities, the site’s footprint will be more than doubled. The investment includes capacity for glucagon-like peptide-1 products, according to a company press release. Construction projects for the expansion have been initiated and will gradually be finalized between 2026 and 2028. More than 500 new jobs are expected to be created, and production activities are expected to run 24/7 upon completion of construction.

“This significant investment announced today confirms the importance of our French manufacturing site, one of our strategic production sites, as a cornerstone of the growth we are experiencing as a company. By maximizing the skills and infrastructure we already have on the site, we are expanding our capacity in an efficient way,” said Lone Charlotte Larsen, corporate vice-president of Novo Nordisk Production Chartres, in the press release.

“Our continued investments in our manufacturing sites across the globe demonstrate the belief we have in our current and future product portfolio and its relevance for people living with serious chronic diseases,” said Henrik Wulff, executive vice-president, Product Supply, Quality & IT, Novo Nordisk, in the release.

Novo Nordisk will invest more than DKK 16 billion (US$2.3 billion) to expand its production facilities in Chartres, France.

Novo Nordisk to Make Multi-Billion Dollar Investment in Expansion of Production Facilities in France

TAU Systems, a US-based producer of compact laser-driven plasma accelerators and light sources, announced on Nov. 21, 2023 that it has signed a lease for a state-of-the-art building in Carlsbad, Calif., in which it will establish TAU Labs. The facility will be the first of the company’s light source applications and R&D centers, which will give users easier access to the latest particle and imaging systems. The first phase of construction is expected to be complete in 2024, according to a company press release.

The company is developing compact particle accelerators and specialized X-ray sources that combine the capabilities of large accelerators with a small footprint. This design is meant to provide easy and affordable beam-time access for any company or research institute, and, by doing so, the facility democratizes accelerator access, allowing for the progress of semiconductors, space-bound electronics, battery technology, biotechnology, and nuclear energy, among other industries, according to the press release.

TAU Systems' particle and light sources comprise the electromagnetic spectrum—from ultraviolet (UV) to gamma wavelengths—and will be installed in a 22,300-ft

 building located at the Carlsbad Research Center. The lab space will house several laser-driven particle and light sources as well as broad technical expertise. Industrial users will have wide access to extreme UV and X-ray light sources as well as million electron volt electrons and other particle beams.

"Laser-driven particle accelerators are incredibly powerful tools that enable unprecedented advances in a wide range of fields, from next-generation semiconductors and batteries, and custom-designed medicines to the advancement of fundamental physics. However, getting beam time on the very few facilities available globally is stifling progress,” said Bjorn Manuel Hegelich, CEO, TAU Systems, in the press release. “TAU's application centers will democratize access to these exciting machines and expedite crucial technological breakthroughs."

"Our high-repetition-rate laser driver also makes TAU Labs an ideal location to test the resistance to space radiation of satellite electronics. It will help make space systems more robust and prolong the life of satellites," said Jerome Paye, chief operating officer, TAU Systems, in the press release.

TAU Systems plans to establish TAU Labs, a new next-generation, laser-driven plasma accelerator laboratory, in Carlsbad, Calif.

TAU Systems to Establish TAU Labs, a New Laser Plasma Accelerator Application Center

On Nov. 21, 2023, Genentech, a member of the Roche Group, announced that it has entered into a multi-year strategic research collaboration with NVIDIA, a US-based computing company. The companies plan to combine Genentech’s artificial intelligence (AI) capabilities, extensive biological and molecular datasets, and research expertise with NVIDIA’s accelerated computing capabilities and AI to speed up drug discovery and development.

The collaboration is meant to significantly enhance Genentech’s advanced AI research programs by turning the company’s generative AI models and algorithms into a next-generation AI platform, which would be designed to expedite the discovery and delivery of novel therapies. Under the agreement, the companies aim to accelerate and optimize Genentech’s proprietary machine learning algorithms and models on the NVIDIA DGX Cloud. The cloud provides a training-as-a-service platform that has been built on dedicated NVIDIA AI supercomputing and software, including NVIDIA BioNemo for generative AI applications in drug discovery.

Also under the agreement, NVIDIA will share its computing expertise with Genentech’s teams of computational scientists, under which Genentech’s models will be optimized and scaled. This process may also improve or enhance NVIDIA’s platforms.

The collaboration will also help accelerate Genentech’s “lab in a loop”, in which extensive experimental data will feed computational models to uncover patterns and make new, experimentally testable predictions. Scientists can then quickly assess these predictions in the lab, and the results are fed back into the models to improve the underlying computational model. This loop is expected to allow for the iterative development of better therapies, according to a company press release.

“By harnessing the power of AI models and algorithms with our unique data and experiments, we're unlocking scientific discoveries with incredible speed and generating insights at an unprecedented scale,” said Aviv Regev, executive vice-president and head of Genentech Research and Early Development (gRED), in the press release. “Bringing science and technology together has always been a foundation of biomedical breakthroughs at Genentech. We are thrilled to join forces with NVIDIA to further optimize our drug discovery and development to deliver treatments that transform people’s lives.”

“The greatest impact of generative AI is to revolutionize the life science and healthcare industry,” said Jensen Huang, founder and CEO of NVIDIA, in the release. “Our collaboration to create Genentech’s next-generation AI platform will dramatically accelerate the pace of drug discovery and development.”

Under this multi-year collaboration, Genentech and NVIDIA will use AI to optimize and accelerate each company’s platforms to discover and develop innovative therapeutics.

Genentech and NVIDIA Form AI Research Collaboration for Drug Discovery and Development

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, announced on Nov. 21, 2023 that it has opened the second phase of its new €29 million (US$43 million) Biologics Testing Center in Shanghai, China, which opened in 2022. The expansion includes an added 1500 m2 of lab space, which are the first biosafety laboratories for the company in the Chinese market. This expansion enables the company to serve local clients, according to a company press release.

The new lab space offers testing services for cell line characterization and lot release from pre-clinical development to commercialization. MilliporeSigma can now offer biosafety testing services for monoclonal antibodies, other recombinant proteins, and cell and gene therapies to the local market.

The first phase of the new testing center allowed the company to provide testing services for viral clearance studies, while the second phase adds capabilities for cell line characterization to help ensure the safety, purity, and identity of cell banks. The testing center also offers current good manufacturing practice-compliant lot release testing for unprocessed and purified bulk harvest for meeting the requirements for biologics that are entering preclinical and clinical studies and for licensed biologics.

“The opening of the facility deepens our partnership with our Chinese clients who are at the forefront of shaping modern medicine,” said Dirk Lange, head of Life Science Services, Life Science business sector of Merck KGaA, Darmstadt, Germany, in the press release. “The Biologics Testing Center in Shanghai now provides critical local services backed by our more than 75 years of global experience in the testing market.”

MilliporeSigma has expanded its biosafety testing laboratories in Shanghai, China, with the completion of new lab space at its new €29 million (US$43 million) Biologics Testing Center.