Industry Insights

51. Managing The Challenges Of Small Batch Formulations 10/3/2019

    A risk-based investment in understanding GMP manufacturing at small scales can prevent costly issues during scaling development that ultimately affect the timely delivery to patients in need.

52. Microbiology Fills QC Role At A CDMO In Aseptic Filling And Sampling 12/26/2018

    Microbiological contamination is at the top of the CDMO threat list. A CDMO needs to have clearly defined procedures and allow client access to data.

53. Separating, Optimizing Device Evaluation And Design Verification A Key To Medtech Success 1/9/2019

    In medical device design and development, two critical development activities — device evaluation and device design verification — often are treated as one, and this behavior is shockingly detrimental to successful medical device development.

54. The Nesting Instinct 1/27/2014

    When it comes to nesting, lab mice are really not all that different than people. They crave the comforts of home, and construct nests that are sophisticated and surprisingly multifunctional. By Brianna Gaskill, Charles River Laboratories

55. Environmental Isolates: What’s The Proper Use Of In-House Cultures? 6/24/2019

    Use of environmental isolates in the pharmaceutical microbiology laboratory has been increasing in popularity. This article discusses the current regulations andguidance documents, regulatory expectations, and expert opinions on the use of environmental isolates.

56. Can You Trust A Machine For Downstream Bioprocess Buffer Preparation? 11/8/2019

    Is automated buffer preparation a solution to the dilemma of balancing increased production capacity against limited footprint expansion alternatives?

57. Partnership Brings A Better Film For Single-Use Bioprocessing 8/8/2019

    As the impact of extractables and leachables on product stability gained greater visibility in relation to single-use technology (SUT), GE Healthcare and Sealed Air formed a partnership to address the issues with the current film structures in today’s biopharma market. 

58. What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product? 6/4/2015

    When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed. 

59. 4 Tips For Successful Collaboration With Your EU Qualified Person 11/8/2019

    Engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated challenges.

60. Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk? 3/4/2020

    In the face of a pandemic, the value of a robust business continuity plan cannot be overstated. Organizations should actively evaluate those plans, focusing on service providers and partners.