• Is Your CDMO Using These Aidriven Solutions in CMC For Oliogs and Peptides?
    By Published On: January 10, 2025Categories:

    Artificial intelligence (AI) is revolutionizing biomanufacturing by addressing critical challenges, especially in scaling production. AI platforms anticipate and resolve bottlenecks by analyzing vast data sets to detect variability in real time. For example, AI-powered monitoring systems flag deviations in synthesis or purification processes, allowing immediate corrective actions.

  • Rethinking Nitrosamines – Moving Beyond Compliance
    By Published On: January 10, 2025Categories:

    The detection of nitrosamines became a priority after contamination in drugs like sartans, ranitidine, and metformin led to recalls starting in 2018.Nitrosamines are classified as probable human carcinogens (Group 2A) by the IARC. High-profile recalls have triggered global scrutiny, leading to enhanced guidelines by the FDA, EMA, and other agencies.

  • Where Biotech Wins: “The Role of CMC Excellence”
    By Published On: January 10, 2025Categories:

    The development of pharmaceuticals, particularly in biotechnology, hinges on the successful execution of Chemistry, Manufacturing, and Controls (CMC) strategies. These strategies form the backbone of product quality, regulatory compliance, and operational efficiency, yet they are fraught with challenges that can derail timelines, inflate budgets, and impede market access.

  • Operational Excellence Tools in Pharma & Biotech for Driving Efficiency
    By Published On: January 10, 2025Categories:

    Operational excellence is at the heart of transforming pharmaceutical and biotech industries by ensuring streamlined processes, minimizing waste, and improving quality. This document introduces key methodologies and tools, such as Lean, Six Sigma, BPM, Automation, and Supply Chain Optimization, to drive efficient workflows, meet regulatory compliance, and deliver cost-effective solutions.

  • Artificial Intelligence (AI) in Drug Development and Regulatory Decisionmaking
    By Published On: January 10, 2025Categories:

    Define a framework for using AI to support safety, efficacy, and quality assessments. Encourage stakeholder engagement to establish credible and transparent AI applications.

  • CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides
    By Published On: November 23, 2024Categories:

    The field of therapeutic development is undergoing rapid transformation, with oligonucleotides and peptides leading the way as promising solutions for addressing a wide array of diseases.

  • Mastering ADC’s Development
    By Published On: November 22, 2024Categories:

    ADC development involves handling highly cytotoxic payloads that demand strict safety measures. Partner with a CDMO equipped with safety certifications(ex: safebridge) and in-depth toxicology expertise to accurately assess exposure risks.

  • Bispecific Antibodies: Mechanism Overview & Development Challenges
    By Published On: November 22, 2024Categories:

    Traditional antibody therapies are designed to target a single antigen. However, many complex diseases are driven by multiple factors, so inhibiting a single target may fail to achieve significant efficacy.

  • Balancing Innovation and Risk Management in R&D
    By Published On: November 22, 2024Categories:

    Biotech, CDMOs, and big pharma must collaborate strategically to balance innovation with risk management in R&D.

  • 8 Key Insights for Finding the Right CDMO
    By Published On: November 22, 2024Categories:

    The digital transformation of CDMO selection is revolutionizing how partnerships are formed. A digitized RFP (Request for Proposal) process can streamline workflows, improve transparency, and ultimately speed up decision-making.