OP White Papers - random

51. A Common Sense Approach To Sustainability In The Biosimilar Business 4/2/2019

    Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

52. API In Capsule Vs. The Lost Art Of Formulation Development 5/5/2020

    Very few businesses have as specialized a set of needs as those in the pharmaceutical sector. The combination of huge product development costs, large amounts of data and intense regulatory control makes it critical for companies to have needed information as soon as possible in order to meet a varied and closely monitored set of business processes. By Todd Daviau, Ph.D

53. Microtableting: Going Small To Create More Targeted, Effective Therapeutics 5/5/2020

    The desire to create more targeted, effective therapeutics with fewer side effects has driven drug formulators to expand into more technically demanding areas over the past decade. Microtablets are one result of this burst of creativity and engineering expertise. Going small opens up numerous new delivery options, but also creates additional challenges for drug formulators and manufacturers.

54. Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start 4/7/2020

    As pharmaceutical industry faces pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.

55. 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.

56. 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.

57. 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.

58. Mechanistic Modeling Of Chromatography To Speed Up Process Development And Provide Improved Processes 3/2/2020

    Catch up on the current opportunities and challenges for using mechanistic modeling to simulate and predict chromatographic behavior and experiments in silico. 

59. Cell Therapy Logistics 2/11/2019

    Having a sound logistics strategy to ensure that a living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.

60. Is Your CMO Ready For Serialization And Aggregation? 3/20/2019

    While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?