OP White Papers - random

41. 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. 

42. 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.

43. 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. 

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

    Development of novel custom active pharmaceutical ingredients (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. With hundreds of potential partners that drug owners can choose from to develop and manufacture custom API, choosing the best partner can be a challenging task. In this white paper, we explore the importance of purposefully aligning the overall drug development strategy with a partnering strategy.

45. The Use Of Cell-Free Synthesis In The Future Of Modern Medicine 4/2/2019

    Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.

46. 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.

47. 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.

48. Using A CMO To Streamline Process Characterization 3/19/2019

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

49. 5 ADC Manufacturing Challenges You Need To Know 10/1/2019

    Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.

50. 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.