Discover Cerba Research Canada! Formerly known as CIRION BioPharma, our Canadian lab is highly recognized for its integrated bioanalytical and global central laboratory services. With extensive experience in supporting biologics and biosimilar drug development for market authorization in non-clinical and clinical studies, Cerba Research Canada is your trusted and agile laboratory partner for the bioanalytical space. Visit our website to learn more about our expertise and how we can support your research needs: https://lnkd.in/e25tuUEa
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Large Molecule results within your timeline. That’s the proven track record at CMIC, Inc. Bioanalytical testing of biologics to evaluate their pharmacokinetics, pharmacodynamics, safety, and efficacy is required throughout the drug development process. As the pipeline of biologics continues to increase, it is vital to work with a CRO whose expertise in this space can help accelerate your timeline to market. CMIC is that CRO. Learn more about CMIC Inc.: https://lnkd.in/eZxxsdg5 Visit our Large Molecule Service page: https://lnkd.in/eHYYrVGa #LargeMolecules #Bioanalysis #CMIC
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OPCU - Partner Week: Biotech's developing large molecule drugs should attend, finding the right outsourcing partner is critical to drug development strategy! At OPCU events, get your questions answered and find out what you need to know within your selection process of working with CDMO partners, timing , capabilities and cultural fit can all be assessed at the Outsourced Pharma Capacity Update. Just Ask for a follow up meeting after the presentation!
With so many options, do you know which #CDMO is the best fit for your large molecule project? Join our virtual Large Molecule Drug Substance & Development Capacity Update on 5/21, where leading CDMOs will share their current available capacity - and associated capabilities, facility locations, and timelines - to help you identify options for your development and manufacturing needs. Reserve your spot: https://lnkd.in/eQ3HMZ3X Confirmed Presenters: AGC Biologics EirGenix, Inc. JOINN Biologics US Inc. KBI Biopharma Mabion S.A. Samsung Biologics Scorpius BioManufacturing, Inc. Singota Solutions #largemolecule #virtualevent
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In a paper newly published in mAbs, BeiGene authors describe their approach to accelerating innovative anti-tumor drugs into first-in-human trials by incorporating key de-risk strategies. From the abstract: Here, we present a case study of a novel anti-tumor drug in which application of “fast-to-FIH” approaches in combination with BeiGene’s de-risk strategy achieved successful delivery of a complete CMC package within 10 months. A comprehensive comparability study demonstrated that the clinical drug substrate generated from a stable pool and a single-cell-derived master cell bank were highly comparable with regards to process performance, product quality, and potency. This accomplishment can be a blueprint for non-COVID drug programs that approach the pace of drug development during the pandemic, with no adverse impact on the safety, quality, and late-stage development of biologics. https://lnkd.in/eR7GBREe
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Join our CMC-focused webinar on oligonucleotide therapeutics! Our experts will cover quality assessment challenges in this regulatory grey area, including 'large small' molecules, critical quality attributes, and process parameters. Learn how to ensure quality and compliance in early phase studies. Don't miss out on this chance to learn from our experts and discover the latest developments in the field!
Oligonucleotide therapeutics are an emerging field with over a dozen new oligonucleotide drugs approved globally since 2016. This well-established chemical process for synthesizing oligonucleotides gives access to ‘large small’ molecules between 5000 to 20,000 Daltons and positions this therapeutic modality between small molecules and biologicals. Assessing the quality and specifications is often a challenge in this regulatory grey area, given the fact that ICH guidelines consider this modality as a chemical entity while sharing properties with biologics. Tune into our webinar to hear our experts discuss CMC IMP considerations for Oligonucleotides, including the critical quality attributes (CQAs) and critical process parameters (CPPs) in oligonucleotide drug product development, plus guidance on setting and meeting specifications to ensure quality and compliance when progressing into early phase studies. Register here: https://ow.ly/W56P50SMUpF
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Oligonucleotide therapeutics are an emerging field with over a dozen new oligonucleotide drugs approved globally since 2016. This well-established chemical process for synthesizing oligonucleotides gives access to ‘large small’ molecules between 5000 to 20,000 Daltons and positions this therapeutic modality between small molecules and biologicals. Assessing the quality and specifications is often a challenge in this regulatory grey area, given the fact that ICH guidelines consider this modality as a chemical entity while sharing properties with biologics. Tune into our webinar to hear our experts discuss CMC IMP considerations for Oligonucleotides, including the critical quality attributes (CQAs) and critical process parameters (CPPs) in oligonucleotide drug product development, plus guidance on setting and meeting specifications to ensure quality and compliance when progressing into early phase studies. Register here: https://ow.ly/W56P50SMUpF
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Being hippopotomonstrosesquipedaliophobic, the use of the word Oligonucleotide should fill me with dread. But it doesn’t on this occasion. Please do join us for this webinar to hear from ICON’s CMC experts regarding CMC considerations for Oligonucleotides in the context of early phase studies. This will be a great opportunity to learn more about this emerging field. (how many will Google it?!)
Oligonucleotide therapeutics are an emerging field with over a dozen new oligonucleotide drugs approved globally since 2016. This well-established chemical process for synthesizing oligonucleotides gives access to ‘large small’ molecules between 5000 to 20,000 Daltons and positions this therapeutic modality between small molecules and biologicals. Assessing the quality and specifications is often a challenge in this regulatory grey area, given the fact that ICH guidelines consider this modality as a chemical entity while sharing properties with biologics. Tune into our webinar to hear our experts discuss CMC IMP considerations for Oligonucleotides, including the critical quality attributes (CQAs) and critical process parameters (CPPs) in oligonucleotide drug product development, plus guidance on setting and meeting specifications to ensure quality and compliance when progressing into early phase studies. Register here: https://ow.ly/W56P50SMUpF
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China Biopharma Tracker – January 2024 Based on data gathered by PharmaDJ, 22 privately held Chinese drugmakers obtained financing in January 2024. 21 disclosed funding worth a total of $519 million. The leading funding recipient is Ji Xing Pharma, a RTW Investment-backed Chinese biotech firm. It specializes in developing novel therapeutics for cardiovascular and ophthalmic diseases. Bayer and RTW announced an equity investment into Ji Xing in the amount of $35 million and $127 million respectively. OnCusp Therapeutics, a pre-clinical stage ADC develooper, inked oversubscribed $100 million in Series A financing co-led by Novo Holdings, OrbiMed, and F-Prime Capital. It is another financing reached $100 million threshold. There were no initial public offerings for Chinese drug developers last month. Second Chinese biotech M&A deal announced this month. Swiss Pharma giant Novartis has inked a deal to acquire SanReno Therapeutics, a Chinese biotech specialized in developing renal diseases. The financial terms didn’t disclosed. 13 licensing deals for Chinese drugmakers were disclosed, worth a total of $4.6 billion, including $357 million in upfront payments. In-licensing deals are only three, worth a total of $337 million, including $15 million in upfront payments. Out-licensing deals are nine, worth a total of $4.2 billion, including $342 million in upfront payments. RNA-focusd biotech Shanghai Argo Biopharma out-licensed a pair of cardiovascular drugs to Novartis, the transction worth $185 million in upfront payments. It is also the only licensing deal with at least $100 million upfront in the month. https://lnkd.in/gif-PxSw
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Please join us in our upcoming webinar series on late-phase biologics drug development!
Register for our upcoming webinar where we’ll be discussing how to embrace risk for a competitive advantage in late-phase biologics development, happening on September 5 at 10am ET/4pm CET/7am PT. Register here: http://spr.ly/6048PcHXE In this webinar, we’ll explore: ▪️ Technical, program, and business risks involved in the scale up and production of biologics for clinical trials and commercialization ▪️ A roadmap for integrating the management of all sources of inherent and avoidable risk into strategy development ▪️ How shifting from implicitly minimizing risk to embracing it can help you gain a significant competitive advantage This is the first webinar of a three-part series on embracing risk in late-phase biologics development. The other two webinars will take place on September 19 and October 10. Stay tuned for more information.
Embracing risk in late-stage biologics drug development
patheon.com
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Check out the latest issue of Blockbuster Biologics Review by Maarika Kimbrell, Kelly Plummer, Margaret Harney, Dr. Jennifer Patritti Cram, and Christopher J. Betti, Ph.D., which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to biosimilars in Q1 2024. #mllifesci #wearemorganlewis https://lnkd.in/gUG59Qw9
Blockbuster Biologics Review | Issue 22
morganlewis.com
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TRA at Hetero Labs Ltd | Ex Intern trainee at STEERlife India Pvt. Ltd. | M. Pharmacy(Industrial Pharmacy) from JSSCPM | PGD in Regulatory Affairs | HME
Completed a certificate course on "Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources" has provided me with valuable insights and takeaways in the field of biosimilars. - Biosimilars are highly similar to reference biologic drugs, but they are not identical due to the complexity of biologics. -Regulatory Framework -Scientific principles behind biosimilarity, including the challenges of characterizing complex biologic molecules. -Case Studies -Interchangeability -Clinical Trials -Market Access and Cost Savings -Resources and References
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