Intertek Pharmaceutical Services’ Post

NEW White Paper | Risk-Based E&L Strategies for Bioprocessing Single-Use Systems. Navigating USP<655>/<1665>, BPOG & other guidance for safe & effective biologics The biopharmaceutical industry has widely adopted single-use systems (SUS) for their efficiency, reduced contamination risk, and streamlined validation. SUS applications range from media bags and tubing to connectors, filters, columns, and bioreactors. While these innovations enhance production and minimize risks, leachables from the plastic materials may compromise product quality and end-user safety. Consequently, extractables and leachables studies on process components are mandatory, but navigating the relevant guidance, such as that from USP <655>/<1665> or BioPhorum Operations Group, can be complex. This white paper delves into the risks due to leachables associated with bioprocessing SUS and explores risk-based strategies for their mitigation. We will navigate the evolving regulatory landscape and explore best practices for extractables and leachables (E&L) testing. Download our white paper now to get the knowledge you need to ensure the safety and quality of your biopharmaceutical products in the era of single-use technology: https://lnkd.in/ecd_EeX5 #ExtractablesAndLeachables #SingleUseSystems #ProductQuality #biologics #biopharmaceuticals

𝗧𝗵𝗲 𝘃𝗶𝘁𝗮𝗹 𝗿𝗼𝗹𝗲 𝗼𝗳 𝗧𝗮𝗻𝗴𝗲𝗻𝘁𝗶𝗮𝗹 𝗙𝗹𝗼𝘄 𝗙𝗶𝗹𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗶𝗻 𝘁𝗵𝗲 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗮𝗻𝗱 𝗹𝗶𝗳𝗲 𝘀𝗰𝗶𝗲𝗻𝗰𝗲 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝗶𝗲𝘀 🧪💡💉   Pharmaceutical manufacturers continually adopt advanced technologies that enhance their processes and products in terms of purity and efficiency. Here, Cross-Flow Filtration (CFF), also known as Tangential Flow Filtration (TFF), has proven pivotal in bioprocessing and drug formulation. The technology uses hollow fibers and cassette filters, and the method is currently revolutionising the industry 💡   Understanding Tangential Flow Filtration 🔍   TFF is a technique used to separate components in liquid mixtures, critical to the production of biopharmaceuticals such as vaccines, antibodies, and therapeutic proteins. Unlike traditional filtration, where the feed flows perpendicularly through the filter, in TFF, the flow is parallel to the filter surface. This approach minimizes filter clogging, making it ideal for processing sensitive biological materials.   There are significant advantages to using TFF in biopharmaceutical manufacturing – enhanced product recovery, scalability, and reduced processing times being some of them, however the method also comes with challenges, like membrane fouling, concentration polarization, and high operational costs.   As we continue to witness the evolution of filtration technology, the integration of innovative membrane materials and process automation stands to redefine production landscapes in life science and paves the way for more efficient and sustainable manufacturing practices.   You can read more about our expertise in filtration technology, TFF (including hollow fiber filters vs. cassette filters) in our article on the subject 👇 https://lnkd.in/dZaF_YDw #TangentialFlowFiltration #bioprocessing #drugformulation #pharmaceuticalmanufacturing #lifescience

✴️ The ÄKTA ready™ 450 by Cytiva is a single-use chromatography system designed for small-scale manufacturing. ✴️ 💡 To meet the needs of purifying small drug volumes, the system has a low flow range of 5 to 450 mL/min per pump and a low hold-up volume. The single-use flow path minimizes the need for cleaning and cleaning validation, allowing for quick changeover between productions and reducing the risk of carryover. Designed for small-scale manufacturing: 📌 Small hold-up volume and flow rate support efficient purification of small drug volumes. 📌 Single-use flow path with option for aseptic connectors to maintain a closed flow path. 📌 Small benchtop footprint makes efficient use of valuable facility space. The ÄKTA ready™ 450 chromatography system offers the performance and documentation required for use in a GMP-regulated environment. 👉 Would you like to know more? Contact us at sales@thesciencesupport.com to discuss your needs, or watch the 📹 below 👇 https://buff.ly/3Upkch8 #chromatography #manufacturing #validation #system #cleanroom #drug #molecules #pharma #pharmaceutical #biotech #biotechnology #biopharma #biopharmaceutical #GMP #regulation

🔍 Simplifying GMP implementation with a risk-based approach to single-use technology in the biotechnology industry. 💡 Upstream processing begins with cell culturing and controlled feeding using different vessel types. 💡 Downstream processing removes contaminants through centrifugation, filtration, and/or chromatography. 💡 Manufacturing involves combining active pharmaceutical ingredients with excipients for drug products. 💡 Analytical technologies are used to characterize biological products, manufacturing processes, and raw materials. 💼 Business partnerships and agreements help navigate the global biopharmaceutical industry. #BioprocessUpdates #GMP #RiskBasedApproach #SingleUseTechnology #Biotechnology #UpstreamProcessing #DownstreamProcessing #Manufacturing #AnalyticalTechnologies #BusinessPartnerships #GlobalBiopharmaceuticalIndustry #CellCulturing #ControlledFeeding #Centrifugation #Filtration #Chromatography ▷ Read the full article here: 📎 https://lnkd.in/dtPG53yF

To stress or not to stress, that is the question! Watch our #webinar with Owen Griffin for an evaluation of stressed microorganisms and their impact on time-to-result (TTR) in #pharmaceutical manufacturing. #microbiology

PROCESS VALIDATION: PROCESS DESIGN (BIOPHARMA MANUFACTURING) - overview of the process design stage of process validation, describing how a biopharmaceutical manufacturing process can be defined using a Quality by Design (QbD) approach that emphasizes accumulated scientific knowledge and quality risk management. Follow SKILLPAD - digital learning for life sciences on LinkedIn at https://lnkd.in/eZt4kHw for more news and updates. Description and screenshots here: https://lnkd.in/eXKYPtEQ Schedule your DEMO here: info@skillpad.com #biopharma #biotechnology #biomanufacturing #biologics #processvalidation #processdesign #qualitybydesign

𝖠 𝖢𝗈𝗆𝗉𝗅𝖾𝗍𝖾 𝖦𝗎𝗂𝖽𝖾 𝗍𝗈 "𝐂𝐨𝐧𝐭𝐢𝐧𝐮𝐨𝐮𝐬 𝐁𝐢𝐨𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐢𝐧𝐠 𝐌𝐚𝐫𝐤𝐞𝐭"[ PDF Guide ] ➤ 𝗚𝗿𝗮𝗯 𝗣𝗗𝗙 𝗙𝗼𝗿 𝗥𝗲𝗽𝗼𝗿𝘁 𝗦𝘂𝗺𝗺𝗮𝗿y @https://lnkd.in/eNjR5qwe continuous bioprocessing market is segmented into upstream processes and downstream processes. Downstream processing is an integral part and the largest process segment in continuous bioprocessing. Additionally, advancements in downstream processing, such as the introduction of multi-column chromatography and single-pass tangential flow filtration, support the segment’s large market share. Further, ultra-scale-down bioprocessing is a recent trend in downstream processing for rapid process development and optimization in biopharmaceutical manufacturing. ▶𝐏𝐫𝐨𝐜𝐞𝐬𝐬 𝐓𝐲𝐩𝐞 1. Upstream Processes 2. Downstream Processes 𝐊𝐞𝐲 𝐏𝐥𝐚𝐲𝐞𝐫𝐬 : Eppendorf AG (Germany), Danaher Corporation (U.S.), Merck KGaA (Germany), Repligen Corporation (U.S.) 3M Company (U.S.), Thermo Fisher Scientific, Inc. (U.S.), Sartorius AG (Germany), ➤ 𝗧𝗼𝗽 𝟭𝟬 𝗟𝗲𝗮𝗱𝗶𝗻𝗴 𝗣𝗹𝗮𝘆𝗲𝗿𝘀: https://lnkd.in/e9j6-wzW #continousbioprocessing #continousbioprocessingmarket#Centrifuges #Antibodies #bioreactor #Chromatography #Centrifuge #pharma #medicines #drug  #downstreamprocesses #vaccine #monoclonalantibodies #helthcare #Vaccines #Pharmaceutical #Biotechnology #Bioreactors #Sterilizers #Centrifuges #Incubators #Shakers #cellculturemedia #Buffers #reagents #consumables 1. 𝐄𝐮𝐫𝐨𝐩𝐞 𝐂𝐨𝐧𝐭𝐢𝐧𝐮𝐨𝐮𝐬 𝐁𝐢𝐨𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐢𝐧𝐠 𝐌𝐚𝐫𝐤𝐞𝐭: https://lnkd.in/e7VBWqim 2. 𝐀𝐬𝐢𝐚-𝐏𝐚𝐜𝐢𝐟𝐢𝐜 𝐂𝐨𝐧𝐭𝐢𝐧𝐮𝐨𝐮𝐬 𝐁𝐢𝐨𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐢𝐧𝐠 𝐌𝐚𝐫𝐤𝐞𝐭: https://lnkd.in/eaEwcxnK

Thoughtful article on the adoption of continuous bioprocessing. #bioprocessing #continuousmanufacturing #biopharmaceuticals #perfusion https://lnkd.in/e_kxaReE

📢 2024: The Year of Breakthroughs in Bioprocessing? 📰 The article discusses whether 2024 will be the inflection point for bioprocessing. 🔬 Bioprocessing begins upstream with culturing animal or microbial cells using different strategies. 💉 Downstream processing removes or reduces contaminants through centrifugation, filtration, and chromatographic technologies. 🏭 Manufacturing involves combining active pharmaceutical ingredients with excipients for delivery to patients. 🔍 Analytical technologies are used to characterize biological products, manufacturing processes, and raw materials. 💼 The biopharmaceutical industry is highly entrepreneurial, with partnerships helping companies navigate the global business environment. 📅 The article suggests that 2024 could be a significant year for bioprocessing advancements. #BioprocessUpdates #bioprocessing #upstream #downstream #manufacturing #analyticaltechnologies #biopharmaceuticalindustry #partnerships #globalbusinessenvironment #bioprocessingadvancements #2024 #pharmaceuticals #biotechnology #innovation #researchanddevelopment ▷ Read the full article here: 📎 https://lnkd.in/dMf7phhz

Aseptic fill finish manufacturing plays a crucial role in ensuring that sterile drugs and biologics remain uncontaminated from production to patient administration. This comprehensive guide breaks down the three critical stages of aseptic processing—preparation, filling, and finishing—while highlighting best practices and innovations like robotics and isolator technology. Stay informed on the latest advancements to uphold the highest standards in pharmaceutical and biotechnology production. Ready to take your aseptic operations to the next level? Read the full article below! #AsepticManufacturing #Biotechnology #SterileProcessing #InnovationInBiotech #AsepticFillFinish