Lonza’s Post

Aurigene Opens #Biologics Facility Offers Process Development and Clinical Scale Manufacturing Capabilities Aurigene Pharmaceutical Services Limited (Aurigene), a Dr. Reddy's Laboratories company, inaugurated its biologics facility spread across 6500 m2 (70,000 sq ft) in Hyderabad, #India. The facility is designed to serve customers with process & analytical development and small-scale manufacturing of #antibodies and other recombinant proteins for preclinical and early-phase clinical requirements. The process and analytical development laboratories are now operational while the commissioning of manufacturing capacity will be completed later in 2024. The state-of-the-art facility is equipped with top-tier equipment and staff, enhancing its current discovery capabilities focused on complex proteins. This addition expands its end-to-end service offering, delivering solutions from discovery to large-scale commercial manufacturing. The new Genome Valley facility will provide robust and compliant cell lines, process development solutions, and analytical methods, supporting customers’ rapid clinical development progression. This initiative is part of Aurigene’s strategy to support growth in both small molecule and biologics spaces, as shown by recent AI/ML-led drug discovery and a collaboration with Vipergen, a DNA-encoded library technologies service provider. Read more on #CMI online: https://lnkd.in/eSUYqrM7

Don't Miss Tomorrows Free Live Webinar Titled mRNA Quality Assessment and USP Guidelines Following the rapid and successful deployment of mRNA vaccines during the COVID-19 pandemic, over 150 mRNA vaccines are in development, with further therapeutic applications in oncology, cardiovascular and genetic diseases and forecasts predict a high level of growth in products using this drug manufacturing platform. USP engaged with stakeholders in government, drug development, pharmaceutical companies and other experts to build consensus on relevant quality attributes for mRNA-based products and appropriate analytical methods. As part of this effort, USP worked with vaccine experts to generate draft guidelines (Analytical Procedures for mRNA Vaccine Quality) and solicited feedback from stakeholders to update and evolve the guidelines. This presentation will provide an overview of USP updated guidelines and plans for further assessment and qualification of analytical methods presented therein. Physical, chemical, and structural elements of drug substance and drug product and how they relate to product quality attributes will also be discussed. Presented by John Cipollo, Ph. D. Team Lead and Senior Principal Scientist, Global Biologics at US Pharmacopeia and Khaled Yamout, Senior Director, Analytical Services and Quality Control at TriLink BioTechnologies, part of Maravai LifeSciences. https://lnkd.in/ew5jc6qJ #mRNA #Vaccines #Quality #AnalyticalMethods #covid19 #Oncology #Cardiovascular #Genetic #Diseases #Biopharmawebinars #Biotech #Biologics #Biopharma

We are thrilled to announce the combination of Biovian and 3P Biopharmaceuticals, two leading biologics CDMOs supported by Keensight Capital. The combined Group, named 3PBIOVIAN, will offer unparalleled end-to-end development and manufacturing services for all protein expression systems and viral vectors, both for Drug Substance and Drug Product, from preclinical to clinical development and commercial phases. Leveraging a joint 40-year track record, expertise, capabilities, and financial strength, the Group will position itself as a leading pan-European independent biologics CDMO, aiming to spearhead the development of drugs tackling patients’ unmet clinical needs. Keensight Capital will continue to help the Group strengthen its leading position at a global level by bringing its 20 years of expertise in healthcare, and its highly international network. Read the press release here: https://lnkd.in/eS8VgK9R #KeensightUpdates #PrivateEquity #GrowthBuyout #Healthcare #CDMO #Biologics

New on Pharma's Almanac: Tanvex CDMO's Xuemei Han, Ph.D., explains how successfully advancing biopharmaceutical drug candidates from early development to clinical trials and commercialization, particularly with accelerating development timelines, requires an in-depth consideration of analytical method development and validation needs. Dr. Xuemei Han is the Director of Analytical Development at Tanvex, leading a team of scientists that focuses on analytical development of biologics. She has over 15 years of experience in analytical development from both academia and biopharmaceutical industry and has contributed to CMC development and IND/BLA filings of multiple biosimilar products. #Biosimilars #Validation #AnalyticalMethodDevelopment

Ever wondered what it takes to transform a brilliant biological idea into a life-changing medicine? Northway Biotech, led by visionary CEO Prof. Vladas Algirdas Bumelis, unravels this mystery in its newest publication. Few takeaways: ✅Flexibility in CDMOs is essential for biologics drug development. ✅Specialized processes and advanced analytical services are critical. ✅Collaboration and a transparent partnership mindset enhance project outcomes. Curious to learn more? Read the article by clicking the link below or contact us at https://lnkd.in/dF3zYhn. #biologics #CDMO #flexibility #partnership

Want to stay at the forefront of R&D? Our latest feature delves into the significance of small molecules in pharmaceuticals. Explore the latest advancements, from streamlined COVID-19 analysis to innovative assays for PROTAC quantification. #pharma #therapeutics #smallmolecules #pharmaceuticals #research #assays #biotechnology

Manufacturing mRNA is challenging, and requires a lot of expertise with the capabilities to support the process. That expertise is especially critical when the goal is drug product for therapeutics and vaccines. Yasser Kehail from Aldevron and Lloyd Jeffs of Precision NanoSystems Inc. (PNI) discussed those challenges in our webinar, Comprehensive GMP Manufacturing of mRNA-LNP Drug Products: Streamlining the mRNA manufacturing process from Sequence-to-Vial, and what Aldevron is doing to help clients overcome those challenges. https://hubs.li/Q01-x82V0

Are you a formulation scientist trying to develop new, more stable formulations of biopharmaceuticals? On Monday Dec 11 Ziccum experts are special guests at a live scientific webinar on ‘Inhaled Biologics’ with inhalation Key Opinion Leader Assoc. Prof. Per Gerde. Ziccum COO Xavier Turon  and CEO Ann Gidner will take part. The webinar will cover: i) how LaminarPace, Ziccum’s Mass Transfer technology, uniquely formulates and dries biologics, without exposing them to extreme temperatures, as stable, bioactive dry powders that are highly suited for inhalation, and ii) Preclinical Testing solutions for Inhalable Formulations. The Webinar is part of a series for industry developers hosted by Inhalation Sciences AB. This session, part of that series, is titled “INHALED BIOLOGICS: Realization and Preclinical Testing of Dry Powder Formulations”. Inhalable solid dose forms of biologics including next-generation mRNA vaccines are of great interest to the biopharmaceutical industry at the moment, promising increased storage stability, simplified patient administration and an ability to stimulate the mucosal immune system. LaminarPace was originally developed by Associate Professor Gerde specifically to dry liquid biologics for inhalation. You can Register and Enroll for the Webinar here (link below post) https://lnkd.in/d8p23np4 #biologics #biotherapeutics #drugformulation #drugdelivery #formulation #inhaledbiologics #vaccines #inhaledvaccines #mrna

2023 marked a difficult year for the entire biopharmaceutical sector. Despite this, #microbiome drug development companies became more creative and collaborative than ever, with partnership and M&A events reaching historical highs. In this must-read 2023 overview, Dr. Luis Gosálbez Cisneros-Miret & Andrea Almagro of Sandwalk BioVentures provide insights into the regulatory and clinical developments, partnership deals and M&A activity, scientific progress and financing trends over the past year: https://lnkd.in/d8pnitwc

It is with great excitement that we announce AlivaMab Biologics as a Gold Sponsor for Biologics 2024 from 13 - 15 March in London. Join us as we explore the cutting-edge of biologics drug discovery with a leader in the field. View the full Agenda https://hubs.la/Q02j-HCb0 AlivaMab Biologics is dedicated to accelerating the biologics drug discovery process with its expansive platform of innovative capability modules. From sophisticated functional assay development to the discovery of binding domains and comprehensive developability assessments, their services encompass the full spectrum of biologics drug modalities. Their commitment to innovation doesn't stop there. AlivaMab Biologics also specializes in the discovery of fully human single-domain VH and multispecific antibodies, setting new standards for therapeutic antibody development. Their approach customizes the pathway to success, allowing partners to select from a full range of services or to customize their choice of individual modules. By attending Biologics 2024, you will gain insight into how AlivaMab Biologics’ cutting-edge techniques and methodologies are defining the path to discovery and development within the biologics sector. To discover the full depth of AlivaMab Biologics’ transformative solutions, visit their https://hubs.la/Q02j-PSg0 #Biologics24 #OGBiologics #AlivaMabBiologics #DrugDiscovery #Biologics #BiotechInnovation #Biopharmaceuticals #TherapeuticAntibodies