ISPE’s Post

Join the conversation and present on a topic you are close to at the 2025 ISPE Aseptic Conference. This event serves as a platform where the newest developments in aseptic processing, robotics, automation, and more are explored in depth. Speakers, exhibitors and attendees alike will have the chance to learn about and discuss these industry advancements. Submissions are open until 29 July. Showcase your insights in key areas, including: • Regulatory, Compliance, and Quality  • Sustainability/Environmental  • Robotization and Digital Revolution of Aseptic Processing  • Advanced Monitoring and Control Systems   • Aseptic Manufacturing and Facilities   • Advanced Therapy Medicinal Products (ATMPs)  • Advances in Aseptic Manufacturing of Antibody Drug Conjugates (ADCs)  • Radiopharmaceuticals  Submit your proposal: https://hubs.la/Q02H4Pzw0 #ISPE #ISPEAseptic #aseptic

Join the conversation and present on a topic you are close to at the 2025 ISPE Aseptic Conference. This event serves as a platform where the newest developments in aseptic processing, robotics, automation, and more are explored in depth. Speakers, exhibitors and attendees alike will have the chance to learn about and discuss these industry advancements. Submissions are open until 29 July. Showcase your insights in key areas, including: • Regulatory, Compliance, and Quality  • Sustainability/Environmental  • Robotization and Digital Revolution of Aseptic Processing  • Advanced Monitoring and Control Systems   • Aseptic Manufacturing and Facilities   • Advanced Therapy Medicinal Products (ATMPs)  • Advances in Aseptic Manufacturing of Antibody Drug Conjugates (ADCs)  • Radiopharmaceuticals  Submit your proposal: https://hubs.la/Q02B4B2l0 #ISPE #ISPEAseptic #aseptic

We’re thrilled to share our latest white paper, which explores how SK pharmteco has evolved the HEK293 cell line to become a game-changer in viral vector manufacturing. 🔬 This comprehensive resource examines how we've enhanced these cells to boost titers and significantly reduce manufacturing costs. Key highlights include: • 𝗢𝗽𝘁𝗶𝗺𝗮𝗹 𝗖𝗲𝗹𝗹𝘀: Discover the importance of selecting the right cells lines for generating CGMP Master Cell Banks. • 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝗺𝗲𝗻𝘁𝘀: Learn about the technical challenges and solutions in developing a high-performing, monoclonal suspension HEK293 cell line for CGMP cell banking. • 𝗜𝗺𝗽𝗮𝗰𝘁 𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻: Our CGMP Serum-free Suspension Cell Line for Universal AAV, LVV, and Ad vectors Production is simplifying the delivery of Advanced Therapies. Whether you're involved in bioprocessing, or viral vector production, this white paper is an invaluable resource for enhancing quality of vector preps, overall scalability, and lowering COGS of your CGMP vector. 🔗 Click the link in the comments to download the white paper and stay ahead in the rapidly evolving world of viral vector manufacturing. #ViralVector #GeneTherapy #Bioprocessing #AAV #LVV #Adeno #Vector #CGMP #Biotech

The second blog in our LC/MS blog series focuses on the advantages of using LC/MS for large molecule bioanalysis. Learn about workflow techniques for direct ingestion and hybrid immunoaffinity LC/MS assays as well as automation platform workflows. Read the blog: https://bit.ly/48rgqrN #drugdevelopment #bioanalysis #lcms #massspectrometry #pharmacokinetics

Continuous manufacturing of biologics offers significant advantages in terms of reducing manufacturing costs and increasing capacity, but it is not yet widely implemented by the industry due to major challenges in the automation, scheduling, process monitoring, continued process verification, and real-time control of multiple interconnected processing steps, which must be tightly controlled to produce a safe and efficacious product. Here, we present a case study of a cyber–physical production system (CPPS) for the continuous manufacturing of mAbs that provides an automation infrastructure for data collection and storage in a data historian, along with data management tools that enable real-time analysis of the ongoing process using multivariate algorithms. The CPPS also facilitates process control and provides support in handling deviations at the process level by allowing the continuous train to re-adjust itself via a series of interconnected surge tanks and by recommending corrective actions to the operator. The proposed system is in line with Industry 4.0 and smart manufacturing concepts and is the first end-to-end CPPS for the continuous manufacturing of mAbs. https://lnkd.in/d6nNEvTc

Join us on November 10 for a discussion on AI risk and compliance in the Pharma and Life Sciences industries. Looking forward to a great discussion! Brian Long Matthew Rich Greg Rotz Brian Riewerts Glenn Hunzinger #pwc #ai #airisk #pharmaceutical #lifesciences #ml

Process optimization of #mRNApurification for #vaccines and #therapeuticapplications Simplifying affinity capture of in vitro transcribed #mRNA is essential for efficient #mRNAvaccine downstream production. Next month, Chantelle Gaskin (Staff Scientist, Field Applications, Thermo Fisher Scientific) will explore a novel affinity solution leveraging the rigid POROS backbone with its linear pressure- flow relationship, enabling a consistent #purificationplatform from process development through to clinical manufacturing. Register for this webinar below: https://buff.ly/3K3UZmA

Interested in #automation of your #celltherapy process? Check out the Fierce Pharma article below to learn more about how #ThermoFisher continues to build innovative CTx partnerships.

Hey BioProcess International 2024 attendees! I can't wait to see you at our booth #114! Timegate is here to help you every step of the way in your biomanufacturing journey, from drug discovery and process optimization to both upstream and downstream processes, as well as end-product quality control. Discover the unique benefits of Timegated® Solutions: ✅ High sensitivity and specificity ✅ Non-destructive and non-contact measurements ✅ Minimal or no sample pre-treatment ✅ Insensitive to ambient light and water ✅ Rapid analysis for quick feedback ✅ Versatile analytical applications to a wide range of biologics ✅ Suitability for automation Our Timegated® analytical tools add substantial value at every stage of biologics development and production by providing detailed molecular insights, enabling real-time monitoring, and ensuring product quality and consistency. Exhibit hours: ▪️ Tuesday, September 24 from 3:30 PM to 7:00 PM ▪️ Wednesday, September 25 from 9:00 AM to 5:30 PM ▪️ Thursday, September 26 from 9:00 AM to 2:00 PM Can't wait to connect with you! #timegating #processmonitoring #bioprocess #BPIconf

To expedite #drugdevelopment, certain stages of preclinical bioanalysis can be automated. Including: ✅ Automated liquid handling ✅ Robotic sample preparation, ✅ Automated analytical instrumentation ✅ High-throughput screening platforms ✅ Laboratory information management systems Learn more about each: https://hubs.li/Q02J4KsG0