Adrienne Ruddle

Ready to streamline your IND and BLA submissions for biologics? Our latest blog provides key considerations and best practices to ensure compliance and facilitate timely approvals. Learn how early FDA engagement and meticulous documentation can make all the difference. https://lnkd.in/eDnazMwc #FDA #IND #BLA #Submissions #Freyrsolutions #pharmaceuticals #biologics

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Complex product formulations and advanced drug delivery systems strain traditional quality control sterility tests. Learn how Celsis ATP-bioluminescence provides definitive contamination detection within days, regardless of formulation complexity.  Learn more: https://okt.to/q39Ir1

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Discover the hurdles in AAV manufacturing discussed by James Cody and the importance of utilizing standardized materials and processes. Check out the full article by Genetic Engineering & Biotechnology News: https://okt.to/anASTR #AAVmanufacturing

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Haven't worked with us before? Learn how our facilities are designed with cGMP manufacturing and ICH regulatory compliance in mind: https://hubs.la/Q02w8Xyd0 #GMP #RegulatoryCompliance #CorealisPharma #CDMO #SolidScience

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What steps do you take to minimize your biologic’s line losses during manufacturing? Biologics are expensive to produce, and minimizing drug substance production loss is a priority for biopharmaceutical companies. One particular concern? Losses during fill-finish operations. Learn how our drug product facility can minimize product losses during fill-finish. https://bit.ly/49HeWKk #biopharma #biologics

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What steps do you take to minimize your biologic’s line losses during manufacturing? Biologics are expensive to produce, and minimizing drug substance production loss is a priority for biopharmaceutical companies. One particular concern? Losses during fill-finish operations. Learn how our drug product facility can minimize product losses during fill-finish. https://bit.ly/44u7K3l #biopharma #biologics

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What steps do you take to minimize your biologic’s line losses during manufacturing? Biologics are expensive to produce, and minimizing drug substance production loss is a priority for biopharmaceutical companies. One particular concern? Losses during fill-finish operations. Learn how our drug product facility can minimize product losses during fill-finish. https://bit.ly/4cH7wIK #biopharma #biologics

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What role does process automation play in helping #MedicalAffairs teams navigate their rapidly evolving and fast-paced industry? Kasia Hein-Peters of Abante Scientific and the BP Logix product team discuss that very question from the lens of #PublicationManagement in this free, on-demand webinar. What is covered? During the webinar, our panel of speakers will: ✅ Lay out the most pressing challenges facing publication teams and medical affairs leaders. ✅ Walk through the pro's and con's of existing solutions — from manual, decentralized systems to established software. ✅ Conduct a demo of #PubPro, the most configurable, easy-to-use publication management platform in the life sciences market.

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NSF’s team of experts discuss 4 traits that define truly exceptional pharmaceutical quality leaders. #nsfexperts #leadership Check out this article to uncover what the experts say: https://bit.ly/3y1cp0m

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Emphasizing early detection, Atossa Therapeutics supports the American Cancer Society's guidelines for regular breast cancer screening. Early detection, through timely mammograms, significantly increases treatment success. Let’s champion proactive health measures together. Learn more: https://lnkd.in/eSzFGJMD #BreastCancer #EarlyDetectionSavesLives bit.ly/EvangelineTrial

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🔍 Seeking expert advice on FDA Pre-Approval Inspections (PAI)? Look no further! Our comprehensive article gives valuable insights on preparing for this critical stage. Stay proactive and ace your inspection! 💯📚 https://lnkd.in/eEReRUiM #FDA #PAI #InspectionPreparation

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The Center for Biocatalysis and Bioprocessing's cGMP Facility is capable of producing protein products for Phase-1 clinical trials. This facility strictly follows the 2008 FDA guidance for cGMP manufacturing of materials for Phase-1 investigational drugs. All cGMP projects are run by our full-time, professional staff with years of manufacturing experience. Say Hi to our amazing GMP Project Manager, Sarah Kasperbauer! Sarah received her B.S. in Biology with a minor in Chemistry from Marymount College of Fordham University in New York. In 1999, she started working as an intern at Acorda Therapeutics, New York, and continued her work there until 2009, during which she focused on mammalian cell culture and protein purification. Sarah came back to Iowa, her home state, in 2009 to join the CBB, where she is currently the GMP Project Manager. Outside of work, Sarah is occupied raising a young son and taking care of her acreage, but, despite her busy schedule, she enjoys spending quality time with family and friends. Don't forget to click that "Follow" button to hear more about our awesome team at the CBB! The CBB is a unit within the Office of Vice President for Research (University of Iowa Research) at the University of Iowa. Please visit https://uiowa.edu/ to learn more. #scientists #science #scientist #lifesciences #research #biotech #biotechnology #biotechnologystudent #biotechinnovation #biotechindustry #biotechnologyindustry #researchanddevelopment #researchers #biology #biochemistry #biophysics #molecularbiology #cellbiology #biocatalysis #bioprocessing #pharma #pharmaceutical #pharmaceuticals #pharmaceuticalindustry #pharmaindustry #oncology #radiationoncology #dna #proteinexpression #proteinpurification #highereducation #fellowship #fellowships #nih #nsf #nsffunded

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Isolator technology continues to see growing utilization in aseptic processing, particularly for highly targeted liquid pharmaceuticals, and increased regulatory emphasis on its application has followed. Key considerations in any fill-finish operation include questions of how to address routine and non-routine interventions and how best to combine automated solutions with a comprehensive risk management strategy.    This is the first of a two-part blog series that explores the current conversation around gloved and gloveless isolator configurations and best practices for strengthening #fillfinish automation.  #cGMP #Innovation 

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Not everyone in Biopharma or Pharma realize all of the work and controls that go into producing parenteral drug products. Sterile drug products are a huge market that just keeps growing! 💉 The demand for weight loss medication continues to drive the strategic planning of Novo Nordisk. Novo said it will spend $4.1 billion to build a second fill-finish plant at its campus in Clayton, #NorthCarolina, the biotech giant’s latest move to meet rising demand for its blockbuster obesity drugs by bolstering manufacturing capacity for current and future injectable treatments. https://lnkd.in/eCceZGCt #parenteral #parenterals #biopharma #pharma #Pharmaceuticals #pharmaceuticalmanufacturing #investments

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#RareDisease is an area of significant focus and expertise for #AmplityHealth. That’s why we were excited when, during a recent panel discussion at #PharmaUSA2024, we had a chance to discuss, how can the #BioPharma Industry make better use of technology to help patients with rare disease.   In her response, Christina DiBiase, Head of Commercial Solutions, discussed the challenges facing rare disease patients and their healthcare providers (HCPs), and shared how Amplity leverages unique data to overcome barriers to diagnosis and treatment.    “One of the things that we’ve been focusing on is how do we get that patient diagnosed much sooner? So, what we’ve done with our proprietary data set, which is called Amplity Insights™, is we’ve indexed millions of data sets of qualitative data that is unstructured, medical transcription records that includes natural language processing, some text mining, and we’ve brought it all to life.”   To hear more about how Amplity is leveraging informed point-of-care qualitative data gathered directly from HCPs to support efforts in the rare disease space, contact us at https://bit.ly/44bUujo.

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Explore Singota Solutions' insights in Contract Pharma's latest feature on the "3 Key Trends" shaping the CDMO industry in 2024 and beyond! In this exclusive article, Singota delves into the emerging trends set to redefine pharmaceutical manufacturing and development. Learn how these advancements are driving innovation, optimizing processes, and enhancing the efficiency of drug development. Don't miss out on insights into the future landscape of the CDMO industry. Read the full article here: https://hubs.li/Q02BS0Qn0 #PharmaTrends #CDMO #ContractPharma #SingotaSolutions

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Whether you're a drug developer exploring regulatory best practices, refining DDI predictions, or delving into the potential of biologics to treat for complex diseases, our latest 𝗦𝗶𝗺𝗰𝘆𝗽 𝗦𝗶𝗺𝘂𝗹𝗮𝘁𝗼𝗿 𝗿𝗲𝗹𝗲𝗮𝘀𝗲 has the features you're looking for. We've got modules tailored to your specific needs – from dose optimization for first-in-human studies to formulation support & biopharmaceutics. Need more guidance? Our consulting team can help! We're here to guide you through every stage, from molecule design to clinical trials. Ready to learn more about the latest in mechanistic modeling technology: https://ow.ly/suWz50Rn9kz #DrugDevelopment #PBPKModeling #Innovation #Simcyp #DDI #VirtualClinicalTrials #Certara

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