Outsourced Pharma White Papers

31. Can Your Clinical Supply Chain Pass The Brexit Pressure Test? 3/13/2018

    - Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask

32. Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins 10/2/2018

    This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

33. In-House Versus Outsource: A Decision-Making Guide 5/2/2018
    Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
34. Digital Manufacturing Of Biologics 2/19/2019

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

35. Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production 8/3/2018

    Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.

36. Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective 6/11/2019

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

37. Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment 8/3/2018

    This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.

38. 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.

39. Virus Safety For Continuous Processing 9/5/2019

    Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

40. What Clinical Teams Should Know About The Benefits Of Auto-Injectors 8/20/2019

    For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.