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WHITE PAPERS AND CASE STUDIES

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• Accelerating CRO Study Deployment At Scale

  A top-3 CRO and a top-10 pharmaceutical company partnered with Medable to help accelerate, scale, and standardize their eCOA trials. See how they accomplished it.

• Antibody-Drug Conjugates – Catalysts For Chemistry

  Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.

• Accelerating Antibody-Drug Conjugate (ADC) Development

  Explore how automated immunoassays help overcome ADC bioanalysis challenges, reducing hands-on time, improving throughput, and enabling multi-analyte workflows for more efficient assessments.

• Streamlining ADC Development: Advantage Of An All-In-One Solution

  Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.

• Getting Started With Product Development Strategies

  Simplify and streamline new product development for success. Explore the importance of new product innovation, different process methods, and best practices for optimizing your company’s strengths.

• Innovative FSP Solutions For Biopharma Growth And Transition

  To optimize clinical development, the pharmaceutical industry is increasingly adopting innovative outsourcing strategies with CROs.

• Why An Integrated Approach Ensures Smooth Entry Into The European Market

  Simplify your EU launch and boost returns. Learn how to manage regulatory hurdles, access a huge patient population, and gain end-to-end commercial support.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• The City Of Fayetteville's Flood Resiliency In The Face Of Climate Change: Mapping 15 Watersheds

  The city of Fayetteville, North Carolina has always had flooding issues, but it’s been getting worse as weather patterns have been changing. They were hit four years in a row by storms Matthew (2016), Irma (2017), Florence (2018), and Dorian (2019). 

• Reducing Lead Time, Delivering >99.5% OTIF

  Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.

• Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility

  The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.