Outsourced Pharma White Papers

1. Factoring The “What Ifs” Into Supply Forecasting 8/24/2020

   This paper discusses considerations for developing a supply plan, the influence of early decisions and impact on outcome as a trial progresses, and how decisions can put patients and the trial at risk.

2. Mechanistic Modeling Of Chromatography To Speed Up Process Development 3/2/2020

   Catch up on the current opportunities and challenges for using mechanistic modeling to simulate and predict chromatographic behavior and experiments in silico. 

3. Considerations for improving outcome in biopharmaceutical process development 8/12/2020

   In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

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

   As the biological drug design space evolves toward formulations with larger dose volume and higher viscosity, the device industry is adapting by developing more innovative delivery systems. To accommodate these advances, delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.

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

   This paper describes how reducing needle length can improve the risk profile of subcutaneous injections and can make injecting viscous formulations easier and quicker, and highlights BD’s development programme for an innovative shorter needle with ultra-thin walls for prefilled syringes.

6. It Hasn’t Been Easy For Pharma To Be Green 10/2/2020

   Most of the drugs coming to market today are acquired by large or mid-size pharma companies from small biotech companies. Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package – one that includes a proven commercialization process minimizing toxic waste that pose safety concerns or require costly remediation.

7. Quantification Of Vector Genomic, Residual DNA In Gene Therapy Vectors 11/10/2020

   Bringing cell and gene therapy drugs to market requires improvement in many areas, including analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.

8. Critical Considerations About The Future Of Global Cell Culture Bioprocessing 4/2/2019

   In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

9. Navigating Regulatory And Development Milestones 9/17/2020

   This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

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

    In addition to wider uptake of home care, an increase in the number of biologics being manufactured, many by the same company, is driving ongoing innovation in drug delivery systems. Identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.