White Papers

31. Multiplexing: Managing Risk With Proven, Single-Use Solutions 10/19/2020

    Instead of trying to make better predictions or erring on the side of overcapacity, developers and CDMOs should seek manufacturing flexibility.

32. Reshoring A Nation’s API And Pharmaceutical Production 10/16/2020

    The pharmaceutical industry has embraced a global supply chain model for decades, seeking cost advantages made available by offshore manufacturing of starting materials, intermediates, and active pharmaceutical ingredients (APIs), particularly in Asia. However, a variety of concerns –– notably underscored by supply chain disruptions driven by the COVID-19 pandemic –– are pushing companies to redraw their global supply chains to resume more domestic manufacturing, aided by new technologies and equipment that can reduce costs.

33. Industry Best Practices For Novel Biotherapeutic Entities 10/14/2020

    As this next wave of antibody-based therapies gains momentum, biochemists have begun to create even more innovative molecules with additional modes of action including multispecific antibodies and other so-called Frankenmolecules. However, informatics technologies have not kept pace with these scientific innovations. It’s unlikely that any single life science company, technology vendor or academic group will be able to solve these issues unaided. But together we can establish systems and processes that make working with these new entities more efficient.

34. Choose A CDMO Partner That Integrates Market Intelligence For Aseptic Fill And Finish 10/13/2020

    Today, a plethora of contract development and manufacturing organizations (CDMOs) provide aseptic fill/finish services around the world. However, to offer customers both favorable outcomes and exceptional value, a CDMO must make the curation and integration of deep market intelligence a core part of its service offering. 

35. How Can We Predict Immunogenicity Earlier? 10/12/2020

    With many biotherapeutics a strong immunogenic response can limit the effectiveness of the treatment or cause a more serious illness. This remains a challenge for scientists as the underlying mechanisms of unwanted immunogenicity still aren’t completely understood. Detecting and preventing unwanted sources of immunogenicity as early in the discovery process as possible has become a top priority for research organizations since biotherapeutic development becomes increasingly costly as it moves downstream.

36. IDMP: An Opportunity For Digital Continuity In The Pharmaceutical Industry 10/11/2020

    Identification of Medicinal Products (IDMP) is an international pharmacovigilance and patient safety initiative addressing this need for global identification of regulated pharmaceutical products during their lifecycle. IDMP is an opportunity for pharmaceutical companies to transform the way in which the continuity of digital information is leveraged and presented to provide a complete definition of the medicinal product, bringing immense business benefits and competitive advantage.

37. Navigate The CMC Regulatory Landscape For Cell And Gene Therapies 10/9/2020

    The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

38. Making The Medicine Go Down: Specialized Oral Solids Delivery Technologies 10/7/2020

    Most oral solid formulations are designed to release the drug immediately after swallowing for rapid absorption into the bloodstream. However, some products have been developed to release the drug in a specific way following ingestion and provide a “controlled-release” of the drug products. In this article, Sandra Conway, Technical Lead at Pfizer CentreOne discusses some of the drug development technologies that provide a more specialized approach to oral dose delivery.

39. The Importance Of End-To-End Thinking During Drug Product Development 10/7/2020

    Throughout a drug product development program it is important to build robustness and flexibility into the manufacturing process. In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

40. Characterization Of Protective Face Masks 10/7/2020

    Face masks that cover the wearer’s mouth and nose, such as surgical masks, are intended to prevent large particles from being expelled by the wearer into the environment and most have a fluid resistant outward-facing layer to protect the wearer against splashes and droplets. This report focusses on the physical characterization of a three-layer pleated mask and a molded cup mask.