Outsourced Pharma White Papers

  1. Considerations In Development & Manufacturing Of Complex Injectables For Early Phase Studies 2/7/2022

    A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.

  2. Accelerating Cell Line And Process Development 8/27/2020

    This paper describes rapid identification of high-producing cell lines, media feed optimization, and a bioreactor scale-up approach for consistent, reliable upstream bioprocess development.

  3. Understanding Of Amorphous Solid Dispersions & Their Downstream Development 2/7/2022

    Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.

  4. Turnkey Solutions To Improve Cell Culture Performance 2/16/2022

    This white paper describes the benefits of a one-step and neutral pH feed optimization strategy, as well as the potential application of chemically defined hydrolysates.

  5. Taking Biotherapeutic Candidates From Late Discovery To The Clinic 1/26/2021

    Many initially promising biotherapeutic candidates fail due to lack of efficacy or safety, but there are candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. 

  6. Oral Controlled Delivery Of Poorly Water-Soluble Drugs 1/27/2022

    Various drug delivery nanotechnologies, such as nano-suspensions, lipid microemulsions, nano-emulsions, and amorphous solid dispersions, have been critical in overcoming bioavailability challenges.

  7. Rare Disease: Beginning With The Patient In Mind 3/1/2022

    Designing patient-centric programs can have a resoundingly positive impact on clinical research and the health and life of patients. Consider six ways to "reverse engineer" development strategy to accommodate the true rare disease patient journey.

  8. Formulation Development Strategy For Early Phase Human Studies 1/27/2022

    Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.

  9. Enabling Biologic Drug Delivery Of Volumes Beyond 1 mL 7/22/2020

    Delivery system manufacturers need to manage conflicting requirements and offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.

  10. Using In-Line Sensors For Real-Time Control 9/28/2020

    There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.