Regulatory Articles. App Notes, Case Studies. & White Papers

  1. Extractables And Leachables: Risk Management And Analytical Solutions 10/11/2023

    Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

  2. Sterile Filtration And Quality Risk Management 8/31/2023

    Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

  3. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023

    The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

  4. Specializing In Small And Early-Stage Partners, Not Just Small Batches 8/16/2023

    Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

  5. Creating Accurate, Efficient, And Effective CDMO Project Proposals 8/15/2023

    To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

  6. Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility 3/24/2023

    As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

  7. Inspiring A New Era Of Patient-Centric Medicines 3/23/2023

    Patients are more empowered, making it essential to promote better adherence, improve medical benefits, and bolster market perception. See the technologies enabling this shift toward patient-centricity.

  8. Partnering On An Innovative Hydrogel-Based Treatment For Glioblastoma 3/22/2023

    Treatments for glioblastoma multiforme (GBM) are in high demand. Learn more about the new possibilities for increased dosing and diffusion capabilities offered by nanoformed APIs.

  9. Streamlining The Integrity Testing Process – From Test To Report 2/22/2023

    Discover a digital transformation solution that provides first of its kind data analytics for filter integrity testing. The software helps operators and supervisors reduce time lost through review processes.

  10. Match Your Development And Manufacturing Path To Your IND Milestones 2/17/2023

    The drug development journey is long, expensive, resource-straining, and risky. Discover how to maximize the value of early-phase material and match your development path to your IND milestones.