PHARMACY MARKET, PHARMA TECH
prnewswire | April 18, 2023
Science and technology company Merck and XtalPi Inc., a pioneering pharmaceutical technology company powered by artificial intelligence (AI) and automation, have jointly published a study that highlights the benefits of combining computational workflows with wet lab experiments to advance drug development.
Traditional methods like milling and micronization, used to address undesirable crystal morphologies, can be disruptive and costly. In contrast, molecular dynamics simulations offer valuable insights for better crystallization experiment designs.
The collaboration between Merck and XtalPi focused on the impact of different polymer additives on the crystal habit of metformin HCl, a diabetes medication. By combining Merck's experimental capabilities with XtalPi's morphology prediction platform, a comprehensive screening approach for crystal morphology engineering was developed. XtalPi's custom-made force fields successfully predicted the influence of polymer additives on metformin HCl's crystal habits. The addition of HPMC led to a transformation from a needle-like to a prismatic morphology, in agreement with experimental observations. The publication demonstrates the potential of merging computational methods and experimental expertise for drug formulation optimization.
Dr. Peiyu Zhang, XtalPi's Chief Scientific Officer, said, "By integrating XtalPi's molecular dynamics predictions with Merck's experimental validation, we have taken a step towards the rational engineering of desirable crystal habits. We hope to continue improving this 'dry + wet lab' method with leading industry experts like Merck, in the production of novel therapeutics worldwide."
Dr. Jan Gerit Brandenburg, Head of Digital Chemistry at Merck, added, "Our collaboration with XtalPi is transforming pharmaceutical development. By seamlessly incorporating computer simulations with our experimental formulation expertise in a 'digital-first' approach, we are boosting drug development processes and positively impacting patients' lives."
About XtalPi
XtalPi is a quantum physics and AI-powered pharmaceutical technology platform that provides integrated drug discovery solutions for global pharmaceutical companies. XtalPi has pioneered a new model for drug R&D that leverages a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge. The company applies this three-pronged approach in its R&D platform to accelerate the drug discovery and development process and address unmet needs for patients worldwide.
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PHARMACY MARKET
Businesswire | May 11, 2023
Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced the release of a new integrated pulmonary software and services package. This targeted package will support pharmaceutical companies by streamlining their pulmonary drug development processes, enabling them to make better-informed decisions and bring therapies to market faster.
The pulmonary package offered by Simulations Plus is founded on the industry leading GastroPlus® modeling and simulation platform, which can be used to predict localized exposure in the lungs. That localized exposure data is then utilized to inform the ILDsym™ or IPFsym™ platforms for efficacy predictions. As client ventures launch and progress, Simulations Plus scientists will leverage their 40+ years of combined experience in pulmonary exposure and efficacy modeling to train in-house client experts on how to use the software and create models to accurately predict the exposure and efficacy of their pulmonary assets.
“Developing molecules intended to treat interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) is a daunting challenge; they are serious conditions with no known cures,” explained Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus. “We anticipate that the use of our targeted pulmonary package could lead to an acceleration in the development of treatments to slow or even halt progression of these diseases. By integrating the industry-leading platforms for PBPK/PCAT™, quantitative systems pharmacology (QSP), and the expertise of our scientists, along with the training of in-house scientists, we believe we can help our clients develop therapies that will improve and even extend the lives of patients worldwide.”
“Hiring and retaining skilled modelers is difficult, which is why many companies develop talent from within,” noted Vice President of Business Development Josh Fohey. “While we are always pleased to assist with our clients’ drug development programs as an extension of their team, we also want to empower them to engage with their models and data beyond what is typical with consulting relationships. As part of our Pulmonary Package, client teams benefit from a customized learning package using the tools in their program, implemented with support and guidance from our experts. Together, we can better understand lung absorption and efficacy, and find new treatments for respiratory disease.”
About Simulations Plus
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 artificial intelligence (AI)/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.
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PHARMA TECH
PR Newswire | May 26, 2023
Centrient Pharmaceuticals ("Centrient"), the global business-to-business leader in sustainable antibiotics, next-generation statins and anti-fungals, and Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, today announced they are expanding their existing partnership aimed at broadening Centrient's portfolio of environmentally friendly active pharmaceutical ingredients (APIs), following the success of previous work together.
Ginkgo's ongoing partnership with Centrient focuses on improving the sustainability of fermentation and enzymatic syntheses of beta-lactam antibiotic APIs. In the first phase of this project, Ginkgo delivered an enzyme with significantly improved efficiency, reducing the environmental footprint of enzymatic production of amoxicillin and cephalexin APIs. These semi-synthetic beta-lactam antibiotics are widely prescribed to both children and adults and are on the World Health Organization's List of Essential Medicines. Centrient aims to build on these improvements through ongoing strain projects on Ginkgo's platform which focus on reducing carbon emissions and waste production compared to traditional chemical routes.
"Our partnership with Ginkgo is fully aligned with our main purpose: to improve lives through innovative and sustainable manufacturing of medicines," said Jorge Gil-Martinez, Chief Scientific Officer at Centrient. "The initial success of this collaboration has led us to expand our joint efforts to design new ways of producing essential medicines, minimizing the environmental impact of antibiotic manufacturing. Moreover, as we design and execute our Open Innovation business model, this strategic collaboration creates synergies to accelerate the diversification of our portfolio, a strategic pillar for the future of our company. Access to external disruptive technologies, focusing on enzymes and fermentation, contributes to our vision to be a diversified and integrated partner of choice for generic medicines."
"Our partnership with Centrient, which began in 2021, underscores Ginkgo's commitment to supporting biopharma companies in bringing much-needed innovation to the field," said Kevin Madden, SVP of Platform Commercialization at Ginkgo Bioworks. "We are inspired by the early success we've already seen in our partnership and look forward to expanding our joint efforts to ultimately support better patient outcomes."
About Centrient Pharmaceuticals
Centrient Pharmaceuticals is the global business-to-business leader in sustainable, enzymatic antibiotics, next-generation statins, and anti-fungals. We are a pharmaceutical company with a clear Purpose: to improve lives through innovative and sustainable manufacturing of medicines - saving the lives of millions of people around the world annually.
Regarding our portfolio, we produce and sell intermediates and active pharmaceutical ingredients (APIs), as well as finished dosage forms (FDFs). Our world-leading proprietary enzymatic technology PureActives® ensures an unmatched eco-friendly production process for our high-quality products. Driven by our Purpose and Sustainability through our ESG vision, we aim to create value for Centrient and our stakeholders. Centrient is a Board Member of the AMR Industry Alliance and a long-time advocate for industry responsibility in manufacturing.
Founded 150 years ago as the 'Nederlandsche Gist- en Spiritusfabriek', our company was known as Gist Brocades and more recently DSM Sinochem Pharmaceuticals. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico. Centrient Pharmaceuticals is owned by Bain Capital Private Equity, a leading global private investment firm.
About Ginkgo Bioworks
Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats.
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