OP White Papers - random

  1. 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.

  2. 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.

  3. Avoiding HPAPI Contamination 3/20/2019

    Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes and deploy appropriate containment strategies. 

  4. How To Increase The Solubility And Bioavailability With Hot Melt Extrusion? 3/22/2019

    When executed properly, HME advances poorly soluble compounds in the development pipeline, without adding delays, cost, or significant post-processing activities, and can scale to commercial manufacturing.

  5. Overcoming Bioavailability Challenges In Oral Formulation Development 8/27/2019

    With nearly 90% of developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must address this obstacle by applying approaches to improve an API’s pharmacokinetics. 

  6. 6 Regulatory Changes Affecting Bioprocessing In China 4/2/2019

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  7. Developing A Scalable Process For Adenovirus Manufacturing 4/2/2019

    To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

  8. Addressing New Chromatography Challenges With Fiber Absorbents 6/2/2019

    An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.

  9. Benefits And Challenges Of Driving Modernization In Vaccine Development 6/11/2019

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

  10. How To Avoid High Potency API Contamination 3/22/2019

    To ensure that employee exposures are kept within accepted limits and protect the environment while containing costs, pharmaceutical companies and their contract partners who manufacture and handle high containment compounds must carefully select equipment, outline processes and procedures, and deploy appropriate containment technologies. Having standards in place for engineering controls is the first line of defense against harm from cross contamination or exposure to the patient, manufacturing employees, or the environment when working with HPAPIs.In this paper learn how to determine exposure potential and select the correct equipment and technology.