Renewal Bio’s Post

Considerate perspective from Marcus Schindler of Novo Nordisk in Endpoints News as he discusses the next innovation hurdle for their programs - scalability. "When we’re starting our programs, we’re now thinking about — is it scalable, how can we ever get to tens, or hundreds, of millions of patients with the chemistry?” he said. Bit more background from the operator's perspective is covered by eloquent Rodney Lax's article, "Nice drug... if you can get it" which offers insightful commentary on the topic. Another great read is Boston Consulting Group (BCG) & Synonym's "Breaking the barrier cost on manufacturing". We at Constructive Bio are pioneering the future of biomanufacturing with our revolutionary platform, designed to harness the power of programmable molecules with exotic building blocks through an innovative approach to sense codon reassignment. Our technology stands at the forefront of biotechnology, offering unprecedented fidelity and specificity in the production of complex biomolecules. What sets our platform apart is its unparalleled flexibility and scalability. We are not just experimenting with theoretical models; we are redefining the boundaries of what's possible in bioprocessing. Our approach ensures that as demand grows, our production processes can scale seamlessly, without sacrificing quality or efficiency. With Constructive Bio, we're not just creating molecules; we're building the foundation for the next generation of exciting bioproducts made at scale. Link: https://lnkd.in/eAsDfT8h https://lnkd.in/ep3rDncb https://lnkd.in/eRD_CpHY

The most advanced regulatory processes for complex biological products have been put in place in many countries to provide appropriate regulatory oversight of biotherapeutic products in general, and similar biotherapeutics in particular. This process is still ongoing and requires regular updates to national regulatory requirements in line with scientific developments and up-to-date standards. For this purpose, strong knowledge of and expertise in evaluating biotherapeutics in general and similar biotherapeutic products, also called biosimilars, in particular is essential. Here, we discuss the World Health Organization’s international standard-setting role in the regulatory evaluation of recombinant DNA–derived biotherapeutic products, including biosimilars, and provide examples that may serve as models for moving forward with nonbiological complex medicinal products. A number of scientific challenges and regulatory considerations imposed by the advent of biosimilars are described, together with the lessons learned, to stimulate future discussions on this topic. In addition, the experiences of facilitating the implementation of guiding principles for evaluation of similar biotherapeutic products into regulatory and manufacturers’ practices in various countriesoverthepast10yearsarebrieflyexplained,withtheaimofpromotingfurtherdevelopmentsandregulatory convergence of complex biological and nonbiological products.

Terry Ernest and Maciej Krause are looking forward to attending Bio Integrates in Cambridge on 15th May. Book a meeting with them or stop by the Almac booth to discuss your project. Find out more about our development and manufacturing solutions, and how we can partner with you to support your pipeline. https://hubs.li/Q02wwtRY0 #BioIntegrates2024 Life Science Integrates

🌟 Exciting Update Alert! 🌟 🔬 Get ready to explore the cutting-edge world of biotherapeutics and biosimilars with our latest review article titled "WHO Standards for Biotherapeutics: Evaluating Complex Biological Products," authored by the esteemed experts Ivana Knezevic and Elwyn Griffiths. 📚 This illuminating article delves into the intricate regulatory processes governing biotherapeutic products, offering insights into the evolving landscape of biosimilars evaluation. From the essential role of the World Health Organization to the scientific challenges posed by biosimilars, this article promises to be a thought-provoking read for professionals and enthusiasts alike. 🌍 Let's come together to celebrate the collaboration and expertise behind this groundbreaking article, and stay tuned for its release as we prepare to unravel the complexities of biotherapeutics regulation! #Biotherapeutics #Biosimilars #RegulatoryStandards #WHO #Science #Innovation #StayTuned 🚀

There’s no time to waste in charting new horizons toward #patient success. The first step? Staying informed about the latest #lifesciences developments and discovery. Preview some featured articles in our latest issue of #DIAGlobalForum: ➡️ A Platform Approach to #mRNA Product Development and #Regulation: Necessary and Feasible Now ➡️ Issues, Ideas, and Initiatives: Proposals from the DIA/Harvard-MIT CRS Cell and #GeneTherapy #Executive Roundtable ➡️ See our full May ‘24 publication and previous issues at https://ow.ly/hyWm50RBXx5 #DIA2024 #DIApublications #biotech #biopharma #clinical #trialresearch

Our business model takes a page from the #Biotech playbook by leveraging risk-reward sharing partnerships to bring clinically impactful treatments to patients. Check out CEO David Hochman's #LSIUSA24 presentation, which summarizes our unique approach to #MedTech innovation: https://bit.ly/4dphr6Y LSI #Hypertension #AtheroscleroticArteryDisease

Over 70% of Biopharma companies report that managing and selecting CROs and vendors consume too much of their time. Our team at Bios Health Group has extensive experience working with various CROs and vendors. With a nuanced and intimate understanding of their strengths and weaknesses, we are uniquely positioned to guide Biopharma companies in making informed decisions. Don't let subpar choices hinder your progress! Let Bios Health Group streamline the process for you. Connect with us now to explore how we can enhance your clinical program and take the stress out of selecting and managing your CRO and other vendors. Choose excellence, choose Bios Health Group!  #ClinicalDevelopment #Biotech #clinicalresearch #pharmaceutical #clinicaltrials #drugdevelopment #biotechnology Bios Health Group

In our winter #lifesciences outlook, we examine: ⇛ Easing funding concerns for #biotechs ⇛ Global clinical trial challenges ⇛ Resilient revenue trends for #medtech

In our winter #lifesciences outlook, we examine: ⇛ Easing funding concerns for #biotechs ⇛ Global clinical trial challenges ⇛ Resilient revenue trends for #medtech

In our winter #lifesciences outlook, we examine: ⇛ Easing funding concerns for #biotechs ⇛ Global clinical trial challenges ⇛ Resilient revenue trends for #medtech