Outsourced Pharma White Papers

1. Tumor-Infiltrating Lymphocytes: What, Why, And How 7/1/2020

   As we explore immune mechanisms using technology, we find better ways to fight disease. Here, we focus on targeted, highly personalized cancer therapies called tumor-infiltrating lymphocytes.

2. Enabling Fast, Appropriate Drug Product Supply For Phase 1 Trials 10/30/2020

   Without the ability to move smoothly from lab concept to manufacture to delivery of GMP clinical supplies to patients, critical milestones could be missed, delaying funding commitments from investors.

3. User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe 9/17/2020

   Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.

4. Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy 7/21/2020

   Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

5. 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.

6. Developing TIL Therapies: Sample Collection And Processing 7/16/2020

   While it has been advanced over many years, the process of developing TIL therapies still suffers from certain challenges. This article attempts to lay bare some of these challenges and discuss how novel technological solutions can help overcome them.

7. FDA Designations for Rare Disease Products: A Complete Guide 8/27/2021

   In this paper, we will highlight those designation programs available specifically for products with rare disease indications: their criteria, timelines, maintenance, and benefits.

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. End Of End Point Assays: SPR Analytics In Vaccine Design, Development 2/18/2021

   Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.

10. Strategies For Flexible Manufacturing 6/22/2020

    Custom-designed equipment and suites, flexible manufacturing lines, and alternative delivery and manufacturing approaches are critical to achieving a timely and successful launch in a competitive marketplace.