Outsourced Pharma White Papers

  1. Using A CMO To Streamline Process Characterization 3/19/2019

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

  2. Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation 2/11/2019

    Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.

  3. Fluid Bed Granulation And Melt Granulation In Pharma Manufacturing 3/19/2019

    Affording superior reproducibility and control than other granulation techniques, fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size.

  4. Avoiding HPAPI Contamination 3/20/2019

    Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes and deploy appropriate containment strategies. 

  5. Benefits And Challenges Of Driving Modernization In Vaccine Development 6/11/2019

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

  6. Small Molecule Impurities: A Control System Design Challenge For ADCs 3/11/2019

    Composed of both antibody and small molecule elements, ADCs have a complex structure from which many different impurities can arise.

  7. Enabling Fast And Appropriate Drug Product Supply For Phase 1 Clinical Trials 10/30/2020

    Reducing the timeline from conception to Phase 1 trials can be especially challenging for new and emerging biotechs. Since many of them are completely virtual or have limited lab space capabilities, they often do not have in-house resources and capacity for formulation development. Without the ability to move smoothly from lab concept to the manufacture and delivery of GMP clinical supplies to patients, critical milestones could be missed, potentially delaying funding commitments from investors.

  8. Guidelines To Bring Your Biologic To Market: Are You Prepared? 4/16/2019

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.

  9. Product Development For An Oral Solid Dosage Using Continuous Manufacturing 10/30/2020

    A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.

  10. Best Practices For Biopharmaceutical Technology Transfer: Facility Fit And Process Gap Assessments 11/3/2020

    During a long, complex journey of drug discovery with many specialized activities involved, technology transfer is an intrinsic part of the successful development, manufacturing, and commercialization of a product. Biopharmaceutical technology transfer requires careful planning and evaluation to meet project timelines for scale up and GMP manufacture.