Outsourced Pharma White Papers

51. How Multi-Layer Tablets And Combination Products Are Reshaping Drug Development And Patient Care 5/5/2020

    By Brian McMillan, M.S.Pharm, CoreRX

    The tablet technology that brought Aspirin, Lipitor and innumerable other drugs to billions of patients is evolving into multi-layer and combination products.

52. How Buffer pH And NaCl Affect Size Exclusion Chromatography 4/22/2020

    Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.

53. Avoiding Hemolysis Blood Sample Collection Processing 2/11/2019

    Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.

54. Custom APIs: Aligning Drug Strategy With Partnering Strategy 3/24/2020

    Development of novel custom 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. 

55. Understanding And Controlling Raw Material Variation In Cell Culture Media 9/5/2019

    An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

56. Critical Factors Of Fill Finish Manufacturing For Large Molecules 10/1/2019

    Large molecules require special handling procedures for bulk drug substance, formulation, and sterile filtering and filling of the final drug product, forcing change on many levels of the manufacturing process.

57. Increasing Productivity In Hydrophobic Interaction Chromatography (HIC) Using Capto Resins 2/27/2020

    Downstream processes for biomolecule purification are becoming more complex. Challenges include increasing titers from upstream cell culture, greater diversity of target molecules, and a need for better productivity. HIC has characteristics designed to solve these challenges. In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

58. Scaling A mAb Production Process To A Single-Use Platform 9/27/2019

    The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

59. 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.

60. 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.