Xeolas Pharmaceuticals’ Post

Even if you aren’t in the business of drug manufacturing, I highly recommend this read. It’s a shocking look at how the system broke down and the tragic consequences for patients; a reminder of the awesome responsibility we in the industry have to uphold our quality standards. Be sure to check out the last section with suggestions for how to talk about risks with your medical team.

Secondary #packaging in #biopharma is facing some common pain points that are frequently brought up across the industry. From cartoning to case packing, palletizing, and transporting drug products, issues like packaging material compatibility, automation challenges, and maintaining compliance during transportation are at the forefront of concerns. One of the most frequently mentioned pain points is packaging #integrity — ensuring that cartons and cases can withstand temperature, humidity, and physical stresses, while preserving the stability of the drug products. Another common issue is the balance between #sustainability and #compliance, where the desire for #eco-friendly packaging often conflicts with strict regulatory requirements. Additionally, there are challenges around automation in secondary packaging, where achieving flexibility in production to accommodate different drug formats without compromising quality remains a struggle. We’re also hearing about #labeling errors that arise during the cartoning process and how they lead to costly deviations, recalls, or compliance risks. These are just a few of the concerns I've come across so far, and I’m interested in gathering more input from the community. What do you think are the biggest challenges in biopharma secondary packaging today? Are there innovative solutions that could help address these issues? #BiopharmaPackaging #PackagingChallenges #SecondaryPackaging #PharmaceuticalIndustry #Compliance #Sustainability #Automation

Where innovation meets production. Elevate your brand with our third-party manufacturing expertise. #pharmaquality #medicationmatters #ThirdPartyManufacturing #precisionmedicine #HealthcarePartnerships #PharmaTechnology #pharmaqualityassurance #manufacturingexcellence

Registration is now open: https://lnkd.in/gFj5JFxe Bay Area Research Logistics will be delivering an insightful webinar, delving into the critical significance of quality management within Good Manufacturing Practice (GMP) environments. Facilitating the webinar will be Business Unit Director, Kaitlin Guarasci and Lynn Faubert, Quality Manager, Systems and Validation. In this session, they will explore how effective quality management systems serve as the backbone of biopharma, medical devices and other regulated industries, ensuring products meet rigorous standards for safety, efficacy, and compliance. Bring your questions, and reserve your spot today for this engaging session. #Quality #GMP #GoodManufacturingPractice #compliance #webinar

Unlock the potential of your drug product program with DSI's expert consultants. From navigating scale-up challenges to optimizing production processes, we're here to streamline your journey. Explore our comprehensive drug product services: https://bit.ly/3QYcM2g #DrugProduct #Consulting #ScaleUp #Production #Manufacturing #DSI

Panel Discussion: Digital Labelling for Med-Tech and Beyond! Moderated by Parveen Jain, RAC (Drugs and Devices) , Senior Director, Quality & Regulatory Affairs, Asia Pacific at Fresenius Medical Care, This panel at the Global MedTech Conference brought together industry experts to discuss "Digital Labelling for Med-Tech and Beyond." Panelists included Lipi Chakhaiyar, Director - Regulatory Affairs at Abbott Healthcare, somnath basu, Scientist-F at AMTZ – Vizag, and Rahul Chauhan, RAC (Drugs), Head of Regulatory Affairs at Takeda. Their discussion provided valuable insights on managing design control to enhance product safety and compliance. #GlobalMedTech2024 #RegulatoryAffairs #HealthcareInnovation #MedicalEquipments #DelhiEvent #MedicalTechnology #Leadership #InformaMarkets

Get to KP further. Journey to sustainable packaging across industries for a better future. Talk soon

Ann Vu, JD, RAC, SVP, Regulatory Affairs, Quality Assurance and Clinical at ZimVie contributed an article "Speed to Market: The Role of Regulatory Strategy in a Global Approach" "By understanding global economic opportunities and prioritizing markets with the lowest regulatory burden while maximizing opportunities for growth, companies can enhance their chances of success in the increasingly competitive healthcare landscape" says Ann Vu. The article will also be featured in the forthcoming special print edition on Medical Device Regulatory and Compliance 2024. Read More: https://lnkd.in/gCCSzCZS #globaleconomics #healthcareinfrastructure #medicaldevice

Excited to introduce Juan Martín Carriquiry, Partner at Beyond Conception GmbH, as a speaker at the 🔸6th Drug-Device Combination Products🔸 summit, taking place on October 15-16, 2024, in Berlin, Germany. Juan is a recognized thought leader in the field of Medical Devices and Combination Products across the EU and beyond. With extensive experience in guiding Global Pharma clients through complex compliance challenges, he has been instrumental in helping companies navigate the latest regulatory requirements. As Managing Director at Beyond Conception, Juan has been at the forefront of pioneering efforts in Europe’s Combination Products sector. He has successfully led clients to secure Notified Body Opinions and achieve compliance with key regulations, including the EU MDR, EU IVDR, and other global frameworks. His deep understanding of the EU regulatory landscape and expertise in Notified Body interactions have made him a sought-after speaker at industry-leading conferences. Juan’s approach goes beyond mere compliance; he is dedicated to creating value for his clients by aligning regulatory strategies with business goals. His insights will be invaluable to those attending #VLDDCP 2024. Join us in Berlin to gain from Juan’s wealth of knowledge and experience in the ever-evolving world of Drug-Device Combination Products. 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👇 https://buff.ly/4cH86Xd #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

Success story from one of our clients who needed product for their clinical trial. 👍🚀 Here's what happened: 4 novel products and a placebo to match. Analytical methods validated in-house. Over-encapsulated. Blistered. Carded, kitted, and labeled and ready to ship two weeks ahead of schedule. 🤯 So freaking proud of this team! The power of working with the right team cannot be underestimated. It's the key to achieving success in outsourced manufacturing. --- Know someone who needs product to support a clinical trial? Help them out by tagging them in the comments below!