Biosimilar White Papers

1. Addressing The Evolving Needs Of Variable Drug Delivery Regimens 9/14/2020

   Pharmaceutical companies now have a wearable solution designed to enable new delivery formats in alternate settings and for customization to support adjustments to existing formulations and variations in treatment regimens.

2. Facilitating 21 CFR Part 11 Compliance With Bio4C Orchestrator 8/16/2021

   How Bio4C Orchestrator Software provides technology to support requirements for electronic records and provides a detailed “rule-by-rule” analysis for 21 CFR Part 11 and Annex 11 in tabular form.

3. Rapid Biosafety Testing Enables The Future Of Manufacturing 7/15/2020

   This whitepaper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing that are more aligned with manufacturing trends.

4. Seed Train Intensification Using High Cell Density Cryopreservation 5/14/2020

   High cell density cryopreservation, a perfused seed train, and specially designed expansion medium can create shorter lead times, reduce plant footprints, increase flexibility, and reduce cost of goods.

5. 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.

6. CDMO Collaboration: Foundation For Sterile Injectable Product Success 6/1/2021

   Explore how a small or medium size biotech or pharma company eveloping sterile injectables can benefit from the experience and assistance provided by a CDMO.

7. 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.

8. 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.

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

   Needle innovations, including shorter needles with ultra-thin wall technology for prefilled syringes, support the delivery of drugs with greater volumes and viscosities, enhancing end-user experience.

10. Three Options To Viral Vector Manufacturing Capacity 9/1/2020

    A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.