Gerresheimer’s Post

Our next webinar will cover the drug product development process and common delays when transitioning to commercialization. Excited to have Colleen O'Brien and Aaron T. Frishkorn hosting this discussion!

❄ LATITUDE Pharmaceuticals now offers GMP lyophilization services! ❄ At LATITUDE Pharmaceuticals, we now offer top-tier GMP lyophilization services designed to meet the rigorous demands of Phase1 and Phase2 clinical trial materials. With years of experience in developing complex lyophilized drug formulations, LATITUDE now ensures high-quality manufactured freeze-dried drug products that maintain their integrity and stability. Why choose LATITUDE for GMP manufacture of your lyophilized drug product? 🔬 Expertise in freeze-drying biologics, small molecules, and sensitive formulations 🔬 Customizable batch sizes tailored to early-phase clinical trials 🔬 Adherence to strict regulatory guidelines for cGMP compliance 🔬 Fast turnaround times and flexible project management Let’s connect and explore how LATITUDE can support your clinical development! This is just one of the many updates we’re implementing to enhance our capabilities and better serve your drug development needs. Stay tuned for more exciting announcements or visit https://lnkd.in/gYKG9eV7 to review them all! #Lyophilization #GMPClinicalSupplies #Pharmaceuticals #Biopharmaceuticals #Phase1 #Phase2 #DrugDevelopment #LATITUDEPharma #CRDMO #Flexible #RapidResponse #Innovation 

❄ LATITUDE Pharmaceuticals now offers GMP lyophilization services! ❄ At LATITUDE Pharmaceuticals, we now offer top-tier GMP lyophilization services designed to meet the rigorous demands of Phase1 and Phase2 clinical trial materials. With years of experience in developing complex lyophilized drug formulations, LATITUDE now ensures high-quality manufactured freeze-dried drug products that maintain their integrity and stability. Why choose LATITUDE for GMP manufacture of your lyophilized drug product? 🔬 Expertise in freeze-drying biologics, small molecules, and sensitive formulations 🔬 Customizable batch sizes tailored to early-phase clinical trials 🔬 Adherence to strict regulatory guidelines for cGMP compliance Fast turnaround times and flexible project management Let’s connect and explore how LATITUDE can support your clinical development! This is just one of the many updates we’re implementing to enhance our capabilities and better serve your drug development needs. Stay tuned for more exciting announcements or visit https://lnkd.in/gYKG9eV7 to review them all! #Lyophilization #GMPClinicalSupplies #Pharmaceuticals #Biopharmaceuticals #Phase1 #Phase2 #DrugDevelopment #LATITUDEPharma #CRDMO #Flexible #RapidResponse #Innovation 

If there’s ONE thing you need to know about beneficial interactions with the FDA for combination products it’s to have a well-designed, adaptive regulatory strategy. Here’s what else you should know: https://bit.ly/3OACzcU #CombinationProducts #RegulatoryStrategy #Innovation #Pharmaceuticals

Our Sterile Fill-Finish facility is custom-built to meet market demand for small-scale, sterile drug products having short development timelines. As an integrated CRO/CDMO, we can formulate, fill, and finish your sterile products into pre-sterilized vials or pre-filled syringes for clinical supply. The facility offers drug product (DP) development and clinical manufacturing services for both biologics and small molecules. The new facility also includes two high-speed vial filling lines capable of producing up to 1 million vials per day ranging from 1 to 100mL fill volumes. Syngene has further expansion plans for two additional vial filling isolator lines with capacity for 600 vials/minute and 100 vials/minute respectively.   We offer end-to-end services from GLP-Tox batches to clinical supplies, and process R&D and scale-up to cGMP manufacturing of sterile drug products for biologics and small molecules. We have the ability to seamlessly integrate between DS development, DP development and cGMP manufacturing for both DS and DP. Our Strong technical capabilities and broad parenteral resources help us align with your company’s clinical/commercial objectives, and our shared goal of ‘putting science to work’. For more information on our Sterile fill finish facility and capabilities, visit the link in comments section 🔗 #Syngene #CRO #Clinicaldevelopment

Register for our Webinar coming up with ApiJect Systems! This webinar will break down everything you need to know about transitioning drug products and vaccines into prefilled Blow-Fill-Seal (BFS) drug delivery devices. This session will walk you through the essential steps of shifting from traditional glass vials to BFS technology, which offers major advantages like cost efficiency, transportability, and a more sustainable footprint. But with innovation comes complexity. We’ll dive into the technical aspects of this shift, covering critical factors like material compatibility, process optimization, and regulatory hurdles. Whether you're dealing with biologics, vaccines, or small molecules, BFS has the potential to handle them all—if you approach it the right way. Learn how to use prototyping and feasibility studies to anticipate and solve potential issues, ensuring your drug product’s stability and quality. #Pharma #BFS #DrugDelivery #MedicalDevices #VaccineTech #ClinicalResearch #PharmaceuticalPackaging #Vaccines #Injectables #CMC #CombinationProduct #SterileInjectables #FormulationDevelopment

FDA Published new guidance on post approval requirements for the changes in CCS. This guidance explicitly mentioned the post approval requirements for the changes  CCS (NDA, ANDA & BLA Applications). Below are some highlights of this guidance. Table A: Changes to the Properties of Glass Vials and Stoppers- New Drug Applications/Abbreviated New Drug Applications*. Table B: Changes to the Properties for Glass Vials and Stoppers: Biologics License Applications. Table C: Changes to the Source or Site of Manufacture for Glass Vials and Stoppers: New Drug Applications/Abbreviated New Drug Applications* Table D: Changes to the Source or Site of Manufacture for Glass Vials and Stoppers: Biologics License Applications* Table E: Changes to the Manufacturing or Processing of Glass Vials and Stoppers: New Drug Applications/Abbreviated New Drug Applications Table F: Changes to the Manufacturing or Processing of Glass Vials and Stoppers: Biologics License Applications* Glass vial: Requirements for changes in glass containers composition Change from glass to a new material (e.g., plastic) Change between molded and tubing glass. Change in vial dimensions Switch from amber glass to clear glass (with or without additional photoprotective measures). Change in primary CCS type (e.g., switching from vial to ampule).   Rubber Stoppers: Change in stopper rubber/elastomer material. Changes in how the stopper is supplied (e.g., unprocessed, RTS, and RTU) Change in stopper dimensions. Site change specific requirements: Site of vial or stopper manufacture or processing (no change in supplier). Site of vial or stopper sterilization. Site of vial or stopper testing Site of vial or stopper manufacture or processing (no change in supplier) Site of vial or stopper sterilization Site of vial or stopper testing.   Changes to the Manufacturing or Processing of Glass Vials and Stoppers Changes in vial sterilization or dehydrogenation method (e.g., changing from moist to dry heat) Changes in vial sterilization or depyrogenation process parameters Stopper washing process Stopper siliconization process Changing the method of stopper sterilization (e.g., from moist heat to irradiation). Stopper sterilization process parameters

It’s no secret that the drug development process is a long and strenuous one. Compounds in quantities of the millions are failed every year at initial R&D stage. Preclinical and clinical trials go on to reduce the number of hopeful targets further, ensuring that only the safest, most effective and high-quality IND candidates make it to regulatory approval stage. HMR Labs has helped customers all over the world achieve regulatory approval with our finished product and batch-release testing capabilities. After spending over 35 years delivering these pharmaceutical testing services, we’ve streamlined our expertise and in-house laboratories to ensure that protocols and methodologies can be flexible to suit your most promising drug candidate. If you’re looking for customisable, innovative and analytical-led programs, partner with HMR Labs! Our consultative approach will help you navigate the regulatory pathway ahead of your promising pharmaceutical products! Find out more here https://bit.ly/3ORE2Pb #drugdevelopment #pharmaceuticalmanufacturing #regulatorycompliance #drugcandidates

FDA has Just Released this Draft Guidance REMS Logic Model: A Framework to Link Program Design With Assessment: MAY 2024 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “REMS Logic Model: A Framework to Link Program Design With Assessment.” The guidance describes FDA’s risk evaluation and mitigation strategy (REMS) logic model. The REMS logic model is a framework that FDA recommends, which provides applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS. The aim of applying the REMS logic model is to develop clear goals, objectives, and strategies that align with the intended outcomes and to help applicants of new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) incorporate REMS assessment planning into the design of a REMS. The principles in this guidance apply to designing a REMS, developing a REMS assessment, and modifying a REMS. The purpose of this guidance is to describe FDA’s risk evaluation and mitigation strategy (REMS) logic model. This guidance is not intended to clarify how risk management or a REMS factors into the benefit-risk assessment of a drug.

👉 Essential role of regulatory compliance in building pharma company-CDMO partnership Biologics are significantly more complex than any of the chemically synthesized small molecule drugs. Even minor differences in manufacturing process (e.g. culture conditions) can have substantial, sometimes unpredictable, effects on product’s quality. To ensure that only safe and effective products reach the market, drug agencies enforce stringent regulations that must be adhered to by all entities involved in the manufacturing process, including contract manufacturers and suppliers. Trust and confidence in their regulatory compliance are essential to pave the way for commercial success. 🤝 Choosing the right CDMO partner goes beyond technical expertise; it requires a partner who prioritizes regulatory excellence and understands the critical nature of compliance in biologics manufacturing. By partnering with a CDMO that demonstrates unwavering commitment to regulatory standards, you can confidently navigate the increasingly complex regulations of biologics development. This ensures not only the integrity and safety of the manufactured product but also accelerates its journey to market, providing peace of mind and a competitive advantage in the biopharmaceutical landscape. 🎯 Quality and compliance are at the core of everything we do at Mabion S.A.. Continuous vigilance and oversight from our established Regulatory Team (led by Anna Małecka and Dorota Jaros, introduced in previous posts --> https://lnkd.in/dX7HN8Qv & https://lnkd.in/dR4F3rmr) ensures that all elements of the production process are running in accordance not only with the GMP, but also EMA’s and FDA’s expectations. Compliance is secured throughout the entire lifecycle of the product - development, technology transfer, manufacturing, testing release and logistics. 🔸 Our regulatory specialists also provide strategic counsel and hand-on-support to address any emerging regulatory challenges, while ensuring the timely achievement of set goals. We fully recognize the importance of staying up-to-date with the latest EMA/FDA regulations and Mabion is committed to simplifying this process for our partners. Let’s work together to advance the development of your biologic product with trust and confidence. Learn more about Mabion’s regulatory and consulting services by visiting our website ➡️https://lnkd.in/dbptKrcA.