HALIX’s Post

Ensuring the integrity of our gowns is pivotal in fortifying an effective contamination control strategy, especially with the latest updates to the EU GMP Annex 1. At AFC, we've diligently examined these revisions, highlighting the indispensable role of gowning procedures in sterile manufacturing environments. The Annex reinforces the necessity for trained personnel and meticulous processes, emphasizing gown integrity's pivotal role in thwarting microbial contamination. AFC proudly serves as a stalwart partner to pharmaceutical companies, delivering top-tier cleanroom textiles tailored for personnel use in EU GMP Grade A / ISO 5 cleanrooms. Moreover, our cleanroom wipes, subjected to rigorous testing via the IEST-RP-CC004 method, guarantee unparalleled material integrity. This empowers pharmaceutical partners to confidently combat contamination risks and maintain the pinnacle of product safety and quality. To stay ahead, we recommend joining a webinar series focusing on ANNEX 1 updates led by industry expert Tim Sandle, Ph.D., CBiol, FIScT and Annette Russell from RSSL. #CleanroomTextiles #ContaminationControl #Annex1 #pharmaceuticalmanufacturing

Read this eBook to discover expert strategies for impurity testing and the essential role of ultrapure water in biopharmaceuticals What you will learn: ✅ How to ensure viral safety in vaccines and vectors ✅ How laboratory water purification is optimized for R&D ✅ How ultrapure water improves trace analysis ✅ How purity and impurity analysis shapes biologic drugs Download the eBook now: https://ow.ly/iZ5Q50RQxZV #Sartorius #WaterPurification #Laboratory #LabEssentials #WaterSystems #Arium #UltrapureWater #Biopharmaceuticals #TraceMetal #Qualitycontrol #LifeScience

Hot off the press! Sangamo publishes Simple Western AAV capsid protein ratio and purity assays. In the article, entitled Assessment of Adeno-Associated Virus Purity by Capillary Electrophoresis-Based Western, the authors conclude that Simple Western "is a high-throughput platform that utilizes low sample volumes for a rapid, sensitive, and robust assessment of the identity, composition, and purity of rAAV drug products."  #ProteinSimple #SimpleWestern #GeneTherapy https://lnkd.in/gw-h6Bag

📢 New Article! Discover the latest #PDA letter on in-house GMP validation of #NGS-based assays for viral safety assessment, with insights from our expert, Christoph B. https://buff.ly/3MBn7yQ Following the new regulatory landscape and requirements for implementing #NGS-based assays, learn why #Genedata, with GMP-compliant features, is your trusted partner for simplifying NGS data workflows in a validated setting. PDA - Parenteral Drug Association #GenedataDriven #DigitalizingBiopharma #GenedataSelector #bioinformatics #GMP

#GenedataSelector Expert's Insights on PDA letter now! Please join us and read 👀 this fresh PDA letter on #NGS-based assays for viral safety assessment authored by Christoph B. by clicking below 👆 👆 👆 #PDA #GenedataDriven #DigitalizingBiopharma #GenedataSelector #bioinformatics #GMP #NGS #Genedata

Following the recent PDA Next Generation Sequencing workshop my colleague Christoph shares his insights on #NGS-based assays for viral safety assessment in the latest #PDA letter. https://buff.ly/3MBn7yQ A good read whether your motivation is reducing animal testing, looking to maximize the ROI of your investment in #NGS or to keep current with ICH guidelines #PDA - Parenteral Drug Association #GenedataDriven #DigitalizingBiopharma #GenedataSelector #bioinformatics #GMP

🔥Hot off the press! Sangamo publishes Simple Western AAV capsid protein ratio and purity assays. In the article, entitled Assessment of Adeno-Associated Virus Purity by Capillary Electrophoresis-Based Western, the authors conclude that #SimpleWestern "is a high-throughput platform that utilizes low sample volumes for a rapid, sensitive, and robust assessment of the identity, composition, and purity of rAAV drug products."  #ProteinSimple, #GeneTherapy

The SLP (Silkworm Larvae Plasma) reagent is a broadband approach to detect microbial contamination. The SLP-HS Single Reagent Set II has the capability to identify both peptidoglycan (PG) and (1->3)-β-D-glucan (BDG). The SLP reagent is an incredibly sensitive method because it detects the presence of PG from bacterial cell walls and BDG from most fungi. Learn more: https://loom.ly/qmQ8GsY #Fugalinfections #endotoxins #pyrogentesting #biopharmaceuticals #pyrogen #endotoxintesting #SLPreagent #microbialcontamination #bacterialendotoxintesting #Europeanpharmacopoeia

🕒 Microbiology result in 15 minutes! 🦠 What would you change in your production process if you had #microbiology results in just 15 minutes? 🤔💡 You could start production with the confidence that your production tools are clean! 🌟🏭 IAN detects #bacteria, #yeast, #mold including #spores in just 15 minutes. #pharma #contamination #RMM

Endotoxins can cause death 😳 (What an opening line 😟 But ➡️) Small amounts of these major contaminants in proteins or biologics can cause patients to have endotoxin shock, tissue injury, or even death. Recombinant proteins, particularly those manufactured in E. coli, are often contaminated; a single E. coli cell can release up to 2 million molecules 🤯 It goes without saying - it’s pretty important to remove endotoxins from drugs, injectables and other pharmaceutical products. Despite this, many companies fail to reach levels low enough to meet safety requirements easily. Why? Endotoxin has a strong affinity for binding to surfaces, like the stationary phase of a chromatography column. They basically bind tight to everything - including plastics and glassware - with no intention of moving. Ion exchangers have limited selectivity which means you don’t always get the right levels of endotoxin removal - & protein recovery can be impacted. (Cue Astrea Bioseparations to the party) EtoxiClear® could solve that problem. An affinity product with awesome capacity for binding endotoxin, ( >1,000,000 EU/mL) while maintaining protein recoveries in excess of 95%. It’s also compatible with a broad range of proteins across a wide pH range and its gentle on live samples. And Astrea has scale to its advantage and speed to deliver. The ultimate benefit though - a safe product for the end patient, polished in a time efficient, cost effective way. That’s what this is all about. I let the product speak for itself. https://lnkd.in/eCnSPB3B #endotoxin #phage #virus #bacteriophage #polishing Ps I cringed at the joke too 😅