BUSINESS INSIGHTS, PHARMA TECH
Dalton Pharma Services | February 17, 2023
On February 16, 2023, Dalton Pharma Services, a leading cGMP pharmaceutical firm, announced a significant strategic expansion of its sterile filling and pharmaceutical manufacturing capabilities. The capital expansion plan includes a brand-new, state-of-the-art, and fully automated cGMP sterile filling line that can fill syringes, vials and cartridges under isolator technology. The sterile fill line is integrated with a new cGMP lyophilizer to provide customers with complete sterile finished dosage form manufacturing capabilities.
In compliance with cGMP aseptic filling regulations, the newly launched sterile filling line supports small-scale commercial production to cater to the global market. Additionally, the capital expansion plan comprises further cGMP non-sterile powder filling capacity, enhanced multi-kilogram API manufacturing capabilities, and a better infrastructure for handling and storing organic solvents.
The company's capital expansion plan supports the goal of establishing it as a leading Contract Development and Manufacturing Organization (CDMO). As part of the Seikagaku Group, Dalton's long-term strategy is to provide pharmaceutical and biotechnology customers with high-quality integrated drug discovery, development, and manufacturing services through its North American facility.
Dalton Pharma Services CEO Peter Pekos commented, "This major investment in the expansion of our sterile manufacturing capabilities enables us to meet the needs of our customers as their critical products advance to commercialization." He added, "It also represents a leap forward in both scale and technology for us, placing Dalton at the leading edge of sterile manufacturing capabilities."
(Source – PR Newswire)
About Dalton Pharma Services
Founded in 1986, Dalton is a leading contract pharmaceutical manufacturer that offers integrated chemistry, development, and manufacturing services to biotechnology and pharmaceutical clients worldwide. The company operates from a 42,000 sq. ft. facility where they provide cGMP manufacturing of APIs, sterile injectables, finished drug products, and solid oral dosage forms. It has the capability to produce APIs in gram-to-kilogram quantities, including sterile APIs, and supports clients at any stage of the regulatory process. Dalton's development services include analytical method development, formulation, and polymorphism screening, among others. Additionally, the company offers over 2,500 reference standards, building blocks, metabolites, and impurities via its Dalton Research Molecules business to support the industry's pharmaceutical research programs.
BUSINESS INSIGHTS, PHARMACY MARKET
Caris Life Sciences and Xencor | January 06, 2023
Caris Life Sciences®, a molecular science and technology company, and Xencor, Inc., a clinical-stage biopharmaceutical company, have announced that they will work more closely together to research, develop, and sell new bispecific and multispecific XmAb® antibodies.
This expanded relationship will boost the number of targets and cancer types that Caris will investigate with Caris Discovery, a proprietary multi-omics discovery engine platform. The foundation for drug candidate development on Xencor's XmAb platform will be novel targets and their accompanying validation packages.
Under the terms of the new contract, Xencor will receive worldwide commercial rights to study, develop, and market products aimed at up to three targets discovered through collaboration. In addition, Caris will get an upfront payment and may receive up to $187 million in commercial milestone payments and development. The company will also be eligible for royalties on the net sales of products commercialized as a result of the agreement, as well as future rights for molecular profiling and companion diagnostics.
Caris Discovery leverages the collective force of its unmatched platform by combining the data generated from the primary patient tissues' molecular interrogation using ADAPT™, which integrates the company's extensive catalog of molecular and clinical data.
About Caris Life Sciences
Caris Life Sciences® is a Texas-based molecular science firm revolutionizing healthcare. Its market-leading molecular profiling products analyze DNA, RNA, and proteins to produce a molecular blueprint. This plan shows how patients, doctors, and researchers can use the information to improve outcomes and save lives. The company also uses cutting-edge algorithms for artificial intelligence (AI) and machine learning (ML) to improve precision medicine.
Xencor develops modified antibodies and cytokines for cancer and autoimmune illnesses. More than 20 XmAb® candidates are in clinical development while three are sold by partners. The company’s XmAb technology modifies protein structures to create new therapeutic pathways.
BUSINESS INSIGHTS, PHARMA TECH
Businesswire | March 29, 2023
Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that it established a strategic research collaboration with the Sino-American Cancer Foundation (SACF). This collaboration will leverage Simulations Plus’ staff and Artificial Intelligence-driven Drug Design technology in the ADMET Predictor® software platform to support the discovery and design of novel inhibitors of methylenetetrahydrofolate dehydrogenase 2 (MTHFD2), an emerging cancer target.
Per the terms of the collaboration, Simulations Plus will develop quantitative structure-activity relationship (QSAR) models for efficacy against MTHFD2, using information from SACF as well as academic and patent literature. The biologists, computational and medicinal chemists in the Early Drug Discovery Services team at Simulations Plus will work with the researchers at SACF to define the multi-objective parameters against which the lead molecule(s) will be optimized. The new AIDD Module in ADMET Predictor® will then be employed to generate libraries of virtual compounds that are optimized for potency and other chosen parameters. The teams will select promising candidates for synthesis and testing, and ensuing rounds of QSAR model building and AIDD optimization will be performed until the milestone criteria in the collaboration agreement are achieved.
“We value the trust and confidence SACF has in our team and AI technology to complement and accelerate conventional drug design and lead optimization processes,” said Dr. Jeremy Jones, Principal Scientist at Simulations Plus and project lead. “By combining their drug discovery expertise with our algorithmic and data science know-how, we are confident we will successfully support their hit-to-lead target development activities.”
As part of this agreement, SACF will provide upfront funding to Simulations Plus to design a set number of compounds for efficacy against MTHFD2 which will be exclusive to SACF. Subsequent milestone payments will be made as key research and development goals are met.
“SACF has had an active interest in AI for de novo design for some time, and we have found a trusted partner in Simulations Plus to help us integrate this into our research,” added Dr. Frank Luh, CEO of SACF. “Scientists from the two organizations will work side-by-side to combine SACF’s data with all that Simulations Plus offers to identify the next generation of compounds that could help in the treatment of cancer.”
John DiBella, SLP Division President, said, “The Early Drug Discovery Services offering at Simulations Plus is tailor made for this type of partnership, where our team of experts, including computational, medicinal, and cheminformatics specialists, provide end-to-end AI-driven drug discovery and optimization support to complement the SACF team. Simulations Plus continues to invite future collaborations which benefit organizations and, most importantly, the global communities we serve.”
About Simulations Plus, Inc.
Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.