Brian Spencer

𝐄𝐱𝐩𝐥𝐨𝐫𝐞 𝐤𝐞𝐲 𝐢𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐛𝐞𝐡𝐢𝐧𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 (𝐐𝐂) 𝐬𝐚𝐦𝐩𝐥𝐞𝐬 𝐢𝐧 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐝 𝐛𝐢𝐨𝐚𝐧𝐚𝐥𝐲𝐭𝐢𝐜𝐚𝐥 𝐫𝐞𝐩𝐨𝐫𝐭𝐬 𝐢𝐧 𝐨𝐮𝐫 𝐥𝐚𝐭𝐞𝐬𝐭 𝐛𝐥𝐨𝐠! 📰 Dive into the nuances of their presentation, accuracy, and precision. 👉 https://lnkd.in/g8jNF5Hc Celegence unites a team of seasoned #medicalwriters and #regulatory consultants, specializing in the intricate world of regulated bioanalysis. Our diverse expertise ensures meticulous attention to detail in every client program, with a focus on the critical role of QC samples ensuring accuracy, precision, and compliance. 📧 Are you prepared to enhance your bioanalytical processes? Let's connect: https://lnkd.in/g9bGxh6U #clinicaltrials #biotech #bioanalysis #clinicalresearch #CRO #drugs #bioanalyticalexpertise #drugdevelopment #drugdiscovery #pharma #regulatedbioanalysis #lifesciences #regulatorycompliance

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How important is it to have the appropriate dissolution tests to request a waiver of BE trials from in vitro data? Check out this poster, to learn more about the evaluation of the dissolution behavior of AML and how it relates to its in vivo performance through physiologically based biopharmaceutics modeling. Learn more here: https://lnkd.in/gNEQUtdY

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Are you navigating the complex landscape of sourcing #leukopaks and cellular starting materials for your advanced therapies?     Join us for an on-demand webinar where Matt Chorley, Parijat Jain PhD, and Wini Luty dive into crucial considerations including GMP/GTP compliance and GMP material sourcing efficiency. Gain insights into how to select the right suppliers and streamline your journey through the #CellAndGeneTherapy development pipeline: https://lnkd.in/gZtjSASx     #FDARegulation #CellTherapy #GeneTherapy

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Advancements in Protein Degradation for Cancer Therapy The Patent Highlight reviews three recent patents introducing innovative compositions and methods to enhance enzyme activity and target protein degradation. WO 2024/115890, WO 2024/118966, WO 2024/118960 These patents present groundbreaking advancements in the development of glutarimide-containing compounds and Protein−Protein Interaction Targeted Chimeras (PPI-TACs) aimed at improving therapeutic interventions’ efficacy, selectivity, and stability https://lnkd.in/g3cbaxkp

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✨Is your brand dedicated to skincare excellence? Don't miss out on this incredible opportunity to ehnace your product knowledge! Join Eurofins | CRL for our webinar tomorrow, May 9th, at 1pm EST titled, "Testing Methodologies & Claims for Cell Renewal/Cell Exfoliation Products". ➡Register for May 9th here: https://lnkd.in/gXUeAKn2 📌 Agenda Highlights - Objective of the study method. - Study procedures and how we achieve our objectives. - Data interpretation for study results. 🎯 Who Should Attend? Ideal for brands marketing products like chemical exfoliants, anti-aging serums, and creams, claiming to exfoliate or soften the skin by accelerating cell renewal or cell exfoliation. Why Attend? - Gain insights into testing methodologies that strengthen product claims. - Understand the impact of a test material on natural cell exfoliation and cell turnover. - Elevate your skincare products with scientifically backed knowledge. 📌Stay tuned in at the end of this session for a Q&A with a member of our sales team! ➡Register for May 23rd here: https://lnkd.in/gtND_xER #webinar #skincareproducts #eurofins #GlobalExpertisePersonalTouch #serum #antiaging #exfoliation

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🔬 Explore our new series of technical notes that are all about Therapeutic Drug Monitoring (TDM)! These notes cover various aspects of TDM and provide valuable insights as well as tools used. 1️⃣ LC-MS/MS Analysis of a Panel of 22 Antidepressants: https://bit.ly/4bf0Ilm 2️⃣ LC-MS/MS Analysis of a 14 Analyte Antipsychotic Panel: https://bit.ly/4dIPSWG 3️⃣ Analysis of an 11 Analyte Anticonvulsant Panel: https://bit.ly/3UXwMoe 4️⃣ SPE Optimization for Prescribed Drugs: https://bit.ly/3V0NtPK #TherapeuticDrugMonitoring

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🔬 Big News Alert! 🔬 🌟 FDA, EPA, and USDA join forces to streamline regulation for biotech products! 🌟 Interesting times ahead for the biotech industry as these agencies collaborate to simplify pathways to market while maintaining rigorous safety standards. How do you think this will shape the future of biotech? 💥 #Biotech #Regulation #Innovation #FDA #EPA #USDA

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DataBiologics Can Help.

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RapidFire-MS was invented to address the limitations of traditional LCMS methods used in drug discovery and development. In the early 2000s, LCMS was the primary tool for analyzing large numbers of compounds in drug screening assays. However, it was relatively slow and oftentimes offered more separation than was necessary for MS analysis. To overcome long unnecessary chromatographic times, RapidFire-MS was developed as a high-throughput screening technology that could analyze large numbers of compounds in a short amount of time. The average cycle time for RapidFire was 8 seconds compared to many minutes for LC. This significant improvement in throughput was achieved by faster sampling, shorter flow paths, and bind/elute cleanup (instead of chromatographic separation). RapidFire-MS was designed to meet the demands of the pharmaceutical industry for faster and more efficient drug screening technologies. It has since become a widely used tool in drug discovery, metabolomics, and proteomics. Our cofounders were essential to the creation and commercialization of the RapidFire MS technology – Read about it in our last post![https://lnkd.in/dbGzWZe7] .

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🚀 Exciting collaboration announcement! Kincell Bio and Imugene Limited have unveiled a strategic manufacturing and process development partnership, featuring the sale of Imugene's North Carolina CGMP manufacturing facility and the transfer of process and analytical development activities to Kincell. 💼 The strategic alliance includes a manufacturing supply agreement wherein Kincell will manufacture Imugene's Azer-cel to support ongoing clinical trials. Additionally, Kincell will take over the process and analytical development of Azer-cel to optimize its readiness for commercial production. 🏭 The acquisition of Imugene's 32,800-square-foot CGMP-compliant facility marks a significant milestone for Kincell, enabling them to evolve site capabilities and manufacture a broad portfolio of autologous and allogeneic products. The facility's location in Research Triangle Park (RTP) will facilitate access to talent in the fast-growing biotech hub. 🌍 This partnership underscores the commitment of both Imugene and Kincell to advancing immunocellular therapies and addressing significant unmet medical needs for patients worldwide. 🌐 #PharmaceuticalIndustry #Partnership #TherapeuticInnovation #ImmunocellularTherapies #Biotech #CDMO #Collaboration

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Virtual prediction of potential immunogenic epitope of candoxin protein from Malayan krait (Bungarus candidus) venom. https://ow.ly/ATZ650Qx3yR #Pharmacy #Pharmacolofy #NaturalProducts #Toxin #Antivenom #Neurotoxin #Vaccine

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Get ready for Episode 7 of the GxPodcast! 🎙️ This week, we're joined by Chris Lewis, the Vice President of GMP Quality for Umoja Biopharma. Tune in to hear us discuss quality culture and excellence in life sciences. We look at cell and gene manufacturing, the connection between innovation and purpose, and the importance of data management in our industry. Tune in to the full episode here: 🔗 https://lnkd.in/exW4jkBB #GXPodcast #iPharmGxP

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👨‍🔬💬 𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐍𝐞𝐰𝐬: 𝟑𝟏𝐬𝐭 𝐌𝐚𝐲 𝟐𝟎𝟐𝟒 👩‍🔬💬 🦠 Bristol Myers Squibb announced FDA approval for Breyanzi, a CD19-directed CAR T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved, making it the CAR T cell therapy available to treat the broadest array of B-cell malignancies. 🦠 CARGO Therapeutics announced that it has entered into a securities purchase agreement for a private investment in public equity financing that is expected to result in gross proceeds of approximately $110.0 million. This financing is expected to extend the company's runway through to 2026 and will be key in supporting BLA preparations in addition to advancing CRG-023, their novel tri-specific CAR T program. 🧬 Strand Therapeutics announced that the first patient has been dosed in their Phase 1, first-in-human trial of STX-001, an investigational multi-mechanistic, synthetic self-replicating mRNA technology. In animal models, STX-001's self-replicating mRNA technology induced immunogenic cancer cell death and promoted recruitment of T cells and NK cells to the tumor microenvironment, as well as their activation, by directly expressing an IL-12 payload from the synthetic mRNA directly from the tumor cells themselves. 🦠 Anocca and Shinobi Therapeutics announced a strategic partnership to use Shinobi’s proprietary immune evasive iPS-T cell platform with novel candidate TCRs, discovered and validated by Anocca, to develop a new class of off-the-shelf allogeneic TCR engineered iPS-T-cell therapies. A successful proof of concept outcome will pave the way for the development of treatments in solid tumor indications for broad patient populations. 🦠 Be Biopharma announced FDA clearance of its IND for BE-101, a first-in-class BCM in development for the potential treatment of hemophilia B. The Phase 1/2 clinical trial, BeCoMe-9, is a multi-center, first-in-human dose escalation study designed to assess the safety and preliminary efficacy of BE-101 in adult participants with moderately severe to severe hemophilia B. Be Bio expects to begin dosing participants in the second half of 2024. 🧬 Andelyn Biosciences has been selected to manufacture AAV therapies using its suspension AAV Curator Platform under the California Institute for Regenerative Medicine (CIRM) Accelerating Medicines Partnership, Bespoke Gene Therapy Consortium (BGTC). This partnership aims to advance BGTC’s mission to develop platforms and standards to propel the development and delivery of bespoke gene therapies for millions of people affected with rare diseases. 🛎 My aim is to be the messenger when it comes to your #CGT news. Follow #mCGT to stay updated! #celltherapy #genetherapy #ATMP

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We Are GMP Pros, Inc.® Our approach is different. We lead change from the inside out with a team of technical experts and savvy strategists who know how to navigate FDA-regulated manufacturing. We work person-to-person with your team to offer immediate support, while also building the structures to support long-term change. #manufacturing #fda #engineering #biotechnology #pharma #animalhealth #food

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Discover how computational sequence analysis and 3D structural modeling can speed up your therapeutic discovery process, uncovering potent antibody leads while minimizing liabilities. Learn more about Orion’s Antibody Discovery Suite.

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🌟 Exciting News from Diasorin! 🌟 DiaSorin has just received FDA 510(k) clearance for its updated NxTag Respiratory Pathogen Panel v2, now including SARS-CoV-2 detection! 🎉 This advanced multiplex PCR assay can detect 19 viral and 2 bacterial targets, offering comprehensive insights into respiratory infections. With improvements in test accuracy and ease of use, this panel ensures top-notch performance on the high-throughput Luminex Magpix instrument, which can process 96 specimens per run. 💪🔬 Thanks to support from the U.S. Department of Health and Human Services (HHS) and Human Services' BARDA, DiaSorin has enhanced its capabilities to meet the ongoing challenges of respiratory pathogens. 🤝 Key Highlights: ✅ Includes SARS-CoV-2 along with other coronaviruses, flu A/B, RSV, and more. ✅ Enhanced accuracy and user-friendly design. ✅ Ready-to-use lyophilized reagent wells for convenience. This advancement represents a significant step forward in diagnostic precision and support for public health. 🌍💙 #DiaSorin #FDAApproval #PCR #Diagnostics #SARSCoV2 #HealthcareInnovation #RespiratoryHealth #PublicHealth #BARDA #MedicalResearch #LaboratoryScience #HighThroughputTesting

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