White Papers

41. Precision Powder In Capsule Micro Dosing Accelerates Drug Product Development 9/30/2020

    Advancing active pharmaceutical ingredients (APIs) through the drug product-development lifecycle is fraught with challenges. Development timelines are tight, so it’s crucial to determine early in the process if an API is a viable candidate for clinical testing. A key tool that has emerged to address these combined issues of tight timelines and complex molecules is precision powder micro-dosing in capsules. This paper describes the use of precision micro-dosing to prepare API powder-in-capsule (PIC) dosage forms for oral or pulmonary administration.

42. Opportunities In Preclinical Development 9/28/2020

    Finding ways to optimize the holistic preclinical development.

43. Using In-Line Sensors For Real-Time Control 9/28/2020

    There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.

44. Quality Results Faster With Integrated Pharmaceutical Development Platform 9/23/2020

    How an integrated pharmaceutical development platform can meet the needs of both analytical development and QC teams through shorter turnaround times, fewer repeats and higher quality.

45. Improve Sterility Assurance And Data Integrity In A 503B Compounding Pharmacy 9/18/2020

    Implementing automated technologies and robotics could be the solution 503B compounding pharmacies need to overcome growing issues with sterility and data integrity.

46. Robust By Design: How BD Is Overcoming The Biologics Challenge In Drug Delivery 9/18/2020

    Autoinjectors used with pre-fillable syringes offer multiple benefits, from providing an accurate dosage to reducing the number of needlestick injuries (needles are protected after use). BD-designed autoinjectors can deliver drugs of differing viscosities in a well-integrated robust system.

47. Navigating Regulatory And Development Milestones 9/17/2020

    This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

48. User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe 9/17/2020

    Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.

49. Addressing The Evolving Needs Of Variable Drug Delivery Regimens 9/14/2020

    Pharmaceutical companies continue to advance their clinical development pipelines to develop new and more sophisticated biologics. To be successful, they will need a solution that will enable the delivery and successful commercialization of complex biologics. This article describes a device designed specifically to address the rapidly evolving needs of the pharma industry and meet patient requirements.

50. Meeting The Process Development Challenges Of A Diverse Biologic Pipeline 9/10/2020

    The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.