i-Pharm GxP

i-Pharm GxP's first year is complete! 🎉 It’s been a year of hard work and strong partnerships and we want to thank our committed team and valued clients for helping us achieve great results. From sterile manufacturing to biologics, quality assurance and everything in between, we've collaborated across a range of projects to deliver high-quality solutions and ensure compliance. As we continue to expand our capabilities and expertise, we're look forward to the next year of tackling new challenges and achieving our goals. Our mission remains clear: to ensure patient access to life-saving therapeutics through human-centric partnerships, projects, and solutions. #anniversary #lifesciences #iPharmGxP

A recent $105 million funding round is set to propel innovative gene therapies for chronic kidney disease into the clinic. 🧬 With approximately 840 million people affected globally, this breakthrough has the potential to have a huge impact on our industry. The funding will support a Phase 1/2 trial for a novel treatment targeting IgA nephropathy, a condition that often leads to kidney failure. This pioneering approach utilises gene therapy to restore vital kidney function, paving the way for future clinical applications. ___________ How do you think this breakthrough could shape the future of kidney disease treatment? Leave your thoughts in the comments below. 👇 #lifesciences #kidneydisease #genetherapy #iPharmGxP

Tune in to Episode 6 of the #GxPodcast! 🎧 We had the privilege of speaking with Eckart W Schwarz, MD, President and Founder of a bespoke Life Science Consultancy. Eckart has designed and delivered global strategic and operational solutions in the life sciences sector. His impressive career includes spearheading groundbreaking initiatives at GSK. Join us as we dive into insightful conversations about the globalisation of drug treatment, tech breakthroughs, biopharmaceutical advancements and much more! Listen now: 🎙️ https://lnkd.in/e2wRUhfF #iPharmGxP #LifeSciences #Pharmaceuticals #DrugDevelopment

It's been a while since we've come on here to look at our markets and talk about the work we do within them. 🕣 At i-Pharm GXP, our team of expert consultants partners with clients across three key sectors within global life sciences: 💉 Sterile / Aseptic Manufacturing 🧬 Biologics / Cell & Gene Therapy 🖥️ Medical Devices & Combination Products Explore the slides below to learn more about each of these specialised areas. 🔎 If you have a project in mind and would like to discuss further, reach out to our team or visit our website: 🔗 https://lnkd.in/dS9x-f6K #biologics #medicaldevices #iPharmGxP

Data management and technology play a central role in modern drug development. In Episode 7 of the #GxPodcast, the team explores how AI, machine learning and automation are revolutionizing the life sciences industry. 🤖 Discover the critical role of data integrity, quality and organization in drug development, and how these advancements are paving the way for innovative therapies that offer new hope to patients. The team also delves into the concept of longevity escape velocity and its potential implications for the future of healthcare. _______________ Listen now: 🎙️ https://lnkd.in/epPWCX7p #AI #datamanagement #iPharmGxP

Thrilled to share a recent case where our life sciences consultancy team provided remediation support to an aseptic fill-finish facility dealing with a challenging warning letter and a significant backlog of over 600 open deviations and CAPAs. Over the course of the project, we: ✅ Resolved all critical and major deviations within 7 months ✅ Reduced the backlog by 90% in just 10 months ✅ Enhanced CAPA effectiveness and decreased closure times for deviations and CAPAs ✅ Improved the QMS, providing training and knowledge transfer to prevent re-occurrence ✅ Conducted a mock audit to ensure compliance and prepare for FDA review The result? The warning letter was successfully lifted following a positive FDA audit. 🏆 ________________ Check out the slides below to see how we made it happen! #iPharmGxP #casestudy #pharmaceutical

We're back with the #GxPodcast poll results! 🎙️ 🧬 Cell and gene therapy stole the show, with a whopping 56% of you wanting to hear more on this topic! It's clear that there's a lot of excitement and curiosity around the advancements and potential in this space. Medical Devices and CQV tied for second place, each gathering 22% of the vote. We're thrilled to see such interest in these areas, and we're excited to bring you engaging discussions around these themes. _____________ Keep an eye out for new episodes coming your way! In the meantime, if you haven’t caught up on Season 1 yet, listen here: 🔗 https://lnkd.in/eDUqtnGf #iPharmGxP #cellandgenetherapy #medicaldevices #CQV

Excited to share a case study where our team delivered comprehensive inspection readiness and remediation support for a CMO facing significant challenges in quality production and batch release delays. Our experts conducted a thorough gap assessment, reduced backlog deviations, and implemented a robust investigation system, enhancing their QMS and significantly reducing batch release timelines from 300 days to just 30. 🏆 ________________ Check out the slides below to see how we made it happen! #iPharmGxP #biotech #casestudy

Cell and gene therapy manufacturing is experiencing rapid growth due to the rising demand for personalised treatments. 🧬 Biopharma companies are facing challenges in scaling up production, leading them to rely more on CMOs. These CMOs are providing the necessary technology, expertise, and production capacity. Key trends include increased outsourcing, advancements in manufacturing processes, and the need to navigate complex regulatory environments. This growth in demand is driving innovations in production technology and streamlining the manufacturing process for these advanced therapies. ____________ Leave your thoughts on this industry growth and how they are handling it in the comments below! ⬇️ #cellandgenetherapy #iPharmGxP #lifesciences

We had so much fun recording Season 1 of the #GxPodcast 🎧 If you haven't yet, check it out here: 🔗 https://lnkd.in/e-NT84rg We love to bring you fresh, engaging content, but now we want your help. 🙌 What topics are you most interested in hearing about next? Vote in the poll below to get involved in Season 2! _______________ What should we dive into next? 🧬 Cell and Gene Therapy 🏥 Medical Devices ✅ CQV ✍️ Other - comment below! #iPharmGxP #cellandgenetherapy #medicaldevices