INDUSTRIAL IMPACT, MEDICAL
Kymanox | February 06, 2023
Kymanox, a leading life science-focused professional services firm, recently announced the acquisition of anteris medical GmbH and anteris helvetia AG (collectively anteris). Anteris specializes in assisting the commercialization and development of medical equipment, combination and in-vitro diagnostic products.
This acquisition enables both firms to achieve their common organizational goal of geographic expansion while enhancing their service capabilities by offering clients a greater range of highly specialized services. Customers who bring essential biologics, such as pharmaceuticals, cell and gene therapies (C>s) and biosimilars, medical devices, and drug/device combos to global markets will benefit significantly from the combined service offerings and office locations of the combined firms. In addition, by merging the technological, scientific, and regulatory expertise of both organizations, customers will actually benefit from this synergy to ensure FDA, EMA, Notified Bodies, and other health authorities' compliance and submission excellence.
Anteris, with its offices in Holzkirchen, Germany, and Küssnacht a.R., Switzerland, offers resource-efficient and innovative solutions for end-to-end development, technical documentation, and compliance to the life science and medical device sectors. Members of Anteris' technical, quality, and regulatory teams have decades of collective expertise in combination product and device development, with a focus on biosimilar development and registration, MDR, EU, CE marking, 510(k) submissions, and quality systems regulations across all key markets.
Founded in 2004, Kymanox is a life science professional services firm that provides scientific, engineering, project management, quality, human factors, testing/CQV, QC, and regulatory assistance to firms in the biotechnology, pharmaceutical, medical device, and combination product sectors. It assists in getting products from the bench to the patient and distinguishes itself by providing a wide variety of technical services and products as well as comprehensive project implementation. The company offers its services to clients worldwide from its headquarters in Raleigh (RTP), North Carolina, as well as offices throughout the United States.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Aldevron | January 20, 2023
Aldevron®, a worldwide leader in the custom development and production of plasmid DNA, RNA, and proteins for the biotech sector, recently announced the launch of Eureca-V™ nuclease.
Eureca-V™, licensed from Inscripta®, is the wild-type MAD7® CRISPR Type-V nuclease at research grade, with GMP to follow.
The launch of Aldevron's Eureca-V nuclease at advanced therapies week expands the toolkit of accessible CRISPR nucleases for therapeutic, diagnostic, and agricultural workflows. In addition, a pass-through license for research use is conveyed with the purchase of Eureca-V nuclease, allowing customers to thoroughly examine the product without committing to a long-term licensing agreement.
Vice President and General Manager of Aldevron's Protein Business Unit, Tom Foti, said, "The availability of Eureca-V drives forward the entire genomics medicine industry and enhances Aldevron's position as a supplier of choice for CRISPR drug substances and drug products." He added, "We are proud to work alongside our partners at Inscripta to bring the innovative, off-the-shelf catalog product to market now as well as provide a clear path to GMP in 2023."
(Source – Cision PR Newswire)
Eureca-V at the research grade level ensures the acceleration of CRISPR translational research. In addition, the product will assist academic and commercial scientists seeking a wild-type Type-V CRISPR nuclease that targets T-rich regions of the genome.
Venkata Indurthi, Chief Scientific Officer at Aldevron, expressed, "We are thrilled to offer Eureca-V product at research grade starting today, and later this year, our clients can expect a smooth transition to our GMP product." He further added, "Aldevron's extensive history in CRISPR nucleases allows researchers to develop therapies that will eventually address global health issues."
(Source – Cision PR Newswire)
It will be the third GMP CRISPR nuclease by Aldevron and the first Type-V nuclease available as a GMP catalog product. It is a leader in supplying vital raw materials and reagents used for cell and gene therapy manufacturing. The company's portfolio of CRISPR nucleases is applied globally in preclinical and clinical research applications.
Aldevron is a pioneer in advancing biological science. Its custom development and manufacturing services have provided scientists all across the world with the components they need to accelerate research and create labs for revolutionary science and breakthrough discoveries. The company aims to deliver products and services that contribute significantly to global biological research. It seeks to be the partner of choice forproducing high-quality plasmid DNA, proteins, enzymes, and other biologicals to support its clients' goals.
Premier Research | March 14, 2023
Premier Research has partnered with InSilicoTrials, a leader in using artificial intelligence (AI) and computational modeling and simulation (CM&S) to speed up the development of new therapies and medical devices. Premier Research helps biotech and device companies take their ideas from the idea stage to the commercialization stage. The aim of the partnership is to make it easier, faster, and safer for treatments for rare diseases to get approval from the government.
CM&S and AI have made it possible to use virtual patients in clinical trials in whole or in part, which the FDA approves of in some cases. In silico trials make it possible to create fake control or treatment arms, help figure out how to sign up patients, and predict the safety and effectiveness of new drugs and medical devices more accurately.
The use of synthetic control arms generated using in silico CM&S techniques represents a powerful tool for enabling non-feasible rare disease research, both preclinical and clinical research. In the last five years, Premier Research has been in charge of more than 240 rare disease studies for a wide range of indications. This shows that the company is committed to orphan drug development for a long time. Premier Research is continuing to put money into trials for rare diseases by partnering with InSilicoTrials.
One major advantage of in silico simulation is the ability to investigate 'what if' scenarios, particularly in rare diseases where a larger patient population does not exist. By using biological, molecular, or genetic data to describe rare diseases, in silico models can make synthetic control arms. This, along with Premier Research's expertise in clinical and preclinical development, execution, and regulatory aspects of small population trials, can shorten the time it takes to make effective treatments for rare diseases.
The partnership between Premier Research and InSilicoTrials will focus on smarter in silico study design, leading to a more effective pre-clinical review of trial design parameters and faster submission-ready studies. CEO of InSilicoTrials Luca Emili says that combining modeling and simulation with AI is the best way to improve the R&D process in drug development. This is because it allows sponsors to speed up the development of new treatments, make medical products safer, and lower R&D costs.
About Premier Research
Premier Research is a global company that does clinical research, product development, and consulting. It focuses on using new technologies to design and run smart studies and trials. With more than 2,500 employees in 75 countries, it has a lot of experience in certain therapeutic areas and uses. The company is committed to empowering its customers to meet the unmet needs of patients and offers great benefits and flexible working conditions.