All Content Outsourced Pharma

  1. Small Molecule API Production: Unveiling The Impact Of Fermentation 3/17/2026

    Technological developments have led to growth in the suitability of fermentation for a myriad of applications. Explore the impact of the evolution of synthetic biology and supporting technologies on modern fermentation practice.

  2. Accelerated API Manufacturing: Combining All Process Development Stages 3/17/2026

    During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.

  3. Improvements In ADC Efficacy And Stability 3/17/2026

    Antibody-drug conjugates combine targeted antibodies with potent cytotoxic payloads, but increasing hydrophobicity challenges stability, manufacturability, and pharmacokinetics, driving interest in hydrophilic linker strategies to improve performance.

  4. A Faster Path To Genomic Medicine Feasibility 3/17/2026

    Life Edit accelerates genomic medicine by comparing five editing modalities, engineering new enzymes, and rapidly pinpointing optimal strategies that boost feasibility, cut risk, and speed clinical progress.

  5. Cytovance Biologics Capabilities Update March 2026: Large Molecule 3/17/2026

    How a seasoned development and manufacturing team blends technical depth, reliability, and flexible support to advance large‑molecule programs amid shifting timelines, costs, and regulatory demands.

  6. Minimizing Drug Product Loss In Manufacturing 3/17/2026

    Explore how optimized analytical testing, reduced material wastage, and advanced sterile fill-finish technologies can work together to preserve valuable GMP material without compromising quality.

  7. FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address 3/17/2026

    For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

  8. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

  9. Circular Single-Stranded Cell-Free DNA For Next-Gen Gene Editing 3/16/2026

    Next‑gen circular DNA payloads enhance gene insertion by improving stability, lowering cytotoxicity, and enabling precise, scalable integration across HDR, recombination, and transposition systems.

  10. George Medicines Extends Global Commercialization Of GMRx2 Into Australia And New Zealand With Arrotex Licensing Agreement 3/16/2026

    George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, has entered into an exclusive licensing and supply agreement with Arrotex Pharmaceuticals (“Arrotex”), a leading Australian pharmaceutical company and Australia’s largest supplier of medicines by prescription volume, granting Arrotex exclusive rights to seek regulatory approval of, and to commercialize, GMRx2 in Australia.