OP White Papers - random

31. Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics 2/11/2019

    Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.

32. 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.

33. Guidelines To Bring Your Biologic To Market: Are You Prepared? 4/16/2019

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.

34. 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.

35. Continuous Flow Manufacturing Of Pharmaceutical Ingredients 11/25/2019

    Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

36. 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. 

37. 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. 

38. 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.

39. 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.

40. From Research To Commercial: A Seamless Supply Of Oligonucleotides 4/24/2020

    This white paper discusses how to meet the seamless supply challenge by providing development, scale-up and synthesis capabilities of research to commercial quantities of customized oligonucleotides.