Alexander Aust, MS, MBA’s Post

CEPI has developed a CMC-Framework for successful vaccine development. This Chemistry, Manufacturing and Controls guide is aimed to help developers in building effective strategies to overcome the challenges in vaccine development, including the phases often referred to as the "valleys of death". The Framework lists stage-appropriate deliverables, spanning five key areas: manufacturing process, formulation and stability, analytics, supply chain, and compliance. By emphasizing the critical aspects of CMC development, CEPI's objective is to expedite the progression of vaccine candidates from research to deployment, reducing delays, mitigating risks, and optimizing the overall development process, all while upholding uncompromising quality standards, ultimately increasing the probability of success. https://lnkd.in/dwZmEP_q

At Dr. Reddys, we are excited to share the exceptional outcome of our relentless efforts in Sugammadex API development. Our commitment to innovation and dedication to excellence have led to significant milestones that promise to revolutionise the pharmaceutical landscape. ● The outcome of our Sugammadex API development: ● Consistent API quality (Purity > 99%) and compliance with ICH1 quality ● Identified, characterised, and synthesised nearly 18 complex impurities. ● Advanced analytical tools (React IR, Raman spectroscopy, FBRM for real-time particle size analysis, etc.) and techniques used for process development. ● Innovative chromatographic purification technique adopted to achieve the highest quality (Purity >99%) ● State-of-the-art manufacturing facility designed to handle sensitive information. ● Strict facility controls in place to control the microbial load essential for sterile injectables. To understand our product better, read the white paper here: https://rb.gy/0o53yu #DrReddysXSustainability #GoodHealthCantWait #WeAreDrReddys #DrReddysAPI #ESG #Sustainability #APIPartner #Pharmaceuticals #SugammadexAPI

𝗗𝗼 𝘆𝗼𝘂 𝗻𝗲𝗲𝗱 𝘁𝗼 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗲 𝘆𝗼𝘂𝗿 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗤𝗔/𝗤𝗖? 𝗕𝗿𝘂𝗸𝗲𝗿 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 𝗵𝗮𝘃𝗲 𝘆𝗼𝘂 𝗰𝗼𝘃𝗲𝗿𝗲𝗱. Our 𝗦𝟮 𝗣𝗨𝗠𝗔 𝗦𝗲𝗿𝗶𝗲𝘀 𝟮 XRF spectrometer measures the elemental composition of your samples within minutes, with fast and easy sample preparation – no digestion or dilution needed. Say goodbye to complex prep work and hello to efficiency! Discover more QA/QC solutions for pharma in our flyer “Quality Control of Bulk Materials” below. 𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗲𝗱 𝗶𝗻 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗺𝗼𝗿𝗲? Watch our on-demand webinar, “Where to use XRF in Pharma and Cosmetics: From Raw Material Verification to Monitoring of Heavy Metal Impurities,” to dive deeper into the applications of XRF technology: https://okt.to/VdtHc3 #BrukerAXS #XRF #FTIR #FTNIR #Raman #Pharmaceuticals #QualityControl

𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗠𝟭𝟯𝗔: 𝗞𝗲𝘆 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗼𝗿 𝗜𝗺𝗺𝗲𝗱𝗶𝗮𝘁𝗲-𝗥𝗲𝗹𝗲𝗮𝘀𝗲 𝗢𝗿𝗮𝗹 𝗕𝗶𝗼𝗲𝗾𝘂𝗶𝘃𝗮𝗹𝗲𝗻𝗰𝗲 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 The FDA has released the final guidance “𝗠𝟭𝟯𝗔 𝗕𝗶𝗼𝗲𝗾𝘂𝗶𝘃𝗮𝗹𝗲𝗻𝗰𝗲 𝗳𝗼𝗿 𝗜𝗺𝗺𝗲𝗱𝗶𝗮𝘁𝗲-𝗥𝗲𝗹𝗲𝗮𝘀𝗲 𝗦𝗼𝗹𝗶𝗱 𝗢𝗿𝗮𝗹 𝗗𝗼𝘀𝗮𝗴𝗲 𝗙𝗼𝗿𝗺𝘀”. Prepared under the International Council for Harmonisation (ICH), this guidance covers the scientific and technical aspects of study design and data analysis for bioequivalence (BE) assessment of tablets, capsules, and granules/powders for oral suspension. Reading guidance documents can often be overwhelming and, let's face it, a bit boring. 😴 That's why I've put in the effort to make this carousel, breaking it down into bite-sized content. Stay tuned for more! I'll be uploading additional guidances related to product development in the future. Your feedback and suggestions are always welcome. #FDA #Bioequivalence #Pharmaceuticals #DrugDevelopment #ICHGuidance

𝗗𝗼 𝘆𝗼𝘂 𝗻𝗲𝗲𝗱 𝘁𝗼 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗲 𝘆𝗼𝘂𝗿 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗤𝗔/𝗤𝗖? 𝗕𝗿𝘂𝗸𝗲𝗿 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 𝗵𝗮𝘃𝗲 𝘆𝗼𝘂 𝗰𝗼𝘃𝗲𝗿𝗲𝗱. Our 𝗦𝟮 𝗣𝗨𝗠𝗔 𝗦𝗲𝗿𝗶𝗲𝘀 𝟮 XRF spectrometer measures the elemental composition of your samples within minutes, with fast and easy sample preparation – no digestion or dilution needed. Say goodbye to complex prep work and hello to efficiency! Discover more QA/QC solutions for pharma in our flyer “Quality Control of Bulk Materials” below. 𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗲𝗱 𝗶𝗻 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗺𝗼𝗿𝗲? Watch our on-demand webinar, “Where to use XRF in Pharma and Cosmetics: From Raw Material Verification to Monitoring of Heavy Metal Impurities,” to dive deeper into the applications of XRF technology: https://okt.to/upYjP3 #BrukerAXS #XRF #FTIR #FTNIR #Raman #Pharmaceuticals #QualityControl

𝗗𝗼 𝘆𝗼𝘂 𝗻𝗲𝗲𝗱 𝘁𝗼 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗲 𝘆𝗼𝘂𝗿 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗤𝗔/𝗤𝗖? 𝗕𝗿𝘂𝗸𝗲𝗿 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 𝗵𝗮𝘃𝗲 𝘆𝗼𝘂 𝗰𝗼𝘃𝗲𝗿𝗲𝗱. Our 𝗦𝟮 𝗣𝗨𝗠𝗔 𝗦𝗲𝗿𝗶𝗲𝘀 𝟮 XRF spectrometer measures the elemental composition of your samples within minutes, with fast and easy sample preparation – no digestion or dilution needed. Say goodbye to complex prep work and hello to efficiency! Discover more QA/QC solutions for pharma in our flyer “Quality Control of Bulk Materials” below. 𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗲𝗱 𝗶𝗻 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗺𝗼𝗿𝗲? Watch our on-demand webinar, “Where to use XRF in Pharma and Cosmetics: From Raw Material Verification to Monitoring of Heavy Metal Impurities,” to dive deeper into the applications of XRF technology: https://okt.to/mM32GH #BrukerAXS #XRF #FTIR #FTNIR #Raman #Pharmaceuticals #QualityControl

DSI’s API consulting team brings over 175 years of combined experience to support all phases of small molecule and peptide clinical development and manufacturing. Our extensive international network of CMOs, coupled with deep expertise in applying ICH guidance and interacting with regulatory authorities, ensures your drug substance needs are expertly managed from development through commercialization. Discover more about our drug substance services: https://bit.ly/4fui3bG #APIConsulting #DrugSubstance #SmallMolecule #PeptideDevelopment #CMC #Pharma #Biotech #Manufacturing #ICHGuidance #DSI #LifeSciences"

𝗗𝗼 𝘆𝗼𝘂 𝗻𝗲𝗲𝗱 𝘁𝗼 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗲 𝘆𝗼𝘂𝗿 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗤𝗔/𝗤𝗖? 𝗕𝗿𝘂𝗸𝗲𝗿 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 𝗵𝗮𝘃𝗲 𝘆𝗼𝘂 𝗰𝗼𝘃𝗲𝗿𝗲𝗱. Our 𝗦𝟮 𝗣𝗨𝗠𝗔 𝗦𝗲𝗿𝗶𝗲𝘀 𝟮 XRF spectrometer measures the elemental composition of your samples within minutes, with fast and easy sample preparation – no digestion or dilution needed. Say goodbye to complex prep work and hello to efficiency! Discover more QA/QC solutions for pharma in our flyer “Quality Control of Bulk Materials” below. 𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗲𝗱 𝗶𝗻 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗺𝗼𝗿𝗲? Watch our on-demand webinar, “Where to use XRF in Pharma and Cosmetics: From Raw Material Verification to Monitoring of Heavy Metal Impurities,” to dive deeper into the applications of XRF technology: https://okt.to/nYV7ZW #BrukerAXS #XRF #FTIR #FTNIR #Raman #Pharmaceuticals #QualityControl

We have scalable options to manufacture your #LNP formulations at the development bench all the way up to cGMP commercial supply. For screening and small scale formulations, we utilize different Cytiva (formerly PNI) microfluidic mixing systems. As we scale up and further characterize your drug product, we can keep manufacturing #LNPs with the Cytiva #GMP skid, or we can transition to solvent injection. Our proprietary large-scale mixing system, #MaxMix, is capable of encapsulating batches with up to 100g of #mRNA (as seen in the image below). Check out the video for a complete listing of our capabilities. https://lnkd.in/eJNK78iK #lipidnanoparticles #nanoparticles #RNA #DDS #CRS Controlled Release Society #pharmaceuticalmanufacturing #pharma #biotech #biopharma

🔬 Ensuring Product Safety & Quality: The Role of Container Closure Integrity Testing (CCIT) 💊 In the world of pharmaceutical and biotechnology manufacturing, Container Closure Integrity Testing (CCIT) is crucial to maintaining the sterility, safety, and effectiveness of products. Whether it’s vaccines, injectables, or biologics, ensuring that the packaging system is secure and contamination-free is a top priority. 📦 Why is CCIT important? CCIT helps identify any potential breaches in the packaging system—ensuring that sterile products stay free from contamination and environmental factors like humidity, air, or bacteria do not compromise their quality. 💡 Key Testing Methods: Vacuum Decay & Pressure Decay: Detecting leaks through pressure changes Dye Ingress Testing: Visual test for any dye penetration in the packaging Helium Leak Detection: Using helium as a tracer gas to identify microleaks As the industry embraces more complex and innovative packaging solutions, CCIT remains a fundamental part of the product development lifecycle, ensuring compliance with regulatory standards and patient safety. 📈 Let’s continue advancing pharmaceutical packaging quality to safeguard public health. #PharmaceuticalIndustry #QualityAssurance #SterileProducts #CCIT #PharmaManufacturing #RegulatoryCompliance #Biotechnology