Outsourced Pharma White Papers

  1. Maximizing Batch Yields In Aseptic Manufacturing: High Value Actives 7/10/2020

    Advances in drug and biologics discovery have allowed the development of more sophisticated and highly targeted therapeutics, with active ingredients becoming increasingly costly to manufacture. Handling high-value, complex active ingredients requires a mindset that rigorously protects against unnecessary loss of active ingredient.

  2. Understanding And Controlling Raw Material Variation In Cell Culture Media 9/5/2019

    An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

  3. Identifying Enhanced Needle Solutions And Integrated System Solutions To Serve The Chronic Disease Market 7/17/2020

    Needle innovations, including shorter needles with ultra-thin wall technology for prefilled syringes, support the delivery of drugs with greater volumes and viscosities, enhancing end-user experience.

  4. Telltale Signs You’re With The Wrong CDMO 4/27/2020

    Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

  5. 8 mm Needle – Improving Subcutaneous Chronic Drug Delivery 7/21/2020

    Reducing needle length can improve the risk profile of subcutaneous injections and can make injecting viscous formulations easier and quicker.

  6. Getting Your Investigational Drug Regulatory Ready 12/1/2020

    Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

  7. Critical Factors For Large Molecule Fill/Finish Manufacturing 10/1/2019

    The industry has entered a new drug development era with the explosion of the biologics market. Large molecules require special handling procedures for the bulk drug substance, formulation, and sterile filtering and filling of the final drug product, forcing changes in the manufacturing process.

  8. Business Continuity Program: Maintain Operations During Crises 5/5/2020

    Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

  9. Navigate The CMC Regulatory Landscape For Cell And Gene Therapies 10/9/2020

    The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

  10. NMR And Mass Spectrometry In Pharmaceutical Development 10/26/2020

    Together, nuclear magnetic resonance (NMR) and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition.