OP White Papers - random

41. Strategies To Address The Viral Vector Manufacturing Shortage 3/5/2020

    Accelerating the production of your viral-vector based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.

42. Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process 5/30/2019

    This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

43. Embedding Your Drug Strategy Within A Solid Foundation For Success 3/24/2020

    This white paper looks at the set of trends influencing pharmaceutical development and manufacturing strategy today, and how these drivers are influencing new business models with outsourced partners. 

44. Preparing For Your CDMO Selection Process 10/1/2019

    Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Don't be unprepared from the outset of your search. 

45. LV Scale-Up Workflow In Single-Use Bioreactors For GMP Compliance 11/8/2019

    Cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

46. Utilizing External Collaboration To Accelerate Vaccine Development 11/2/2018

    Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

47. 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.

48. Combination Product Overview: Fixed Dosage 5/7/2020

    With dwindling pipelines, limited resources, & expiring patents, now, more that ever, combination products are being considered in drug development portfolios. However, regulatory hurdles, physician acceptance, and market strategy, are just a few considerations that one should address. This brief overview will cover specifics regarding fixed dosage combinations (FDC’s), and will hopefully give your company a better understanding to the challenges ahead.

49. Viral Clearance: The Basics On How To Conduct Effective Studies 5/17/2019

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

50. Golden Retriever Study: 5 Years Of Progress In Vet Health And Biobanking 2/11/2019

    An overview of a prospective cohort study of some 3,000 young Golden Retrievers, and how extensive data and biological samples will be used for future analyses of major diseases, disorders, or conditions..