Industry Insights

41. DSCSA’s 2023 Interoperability Requirements: Don’t Just Check The Compliance Box 6/27/2019

    The Drug Supply Chain Security Act (DSCSA) requires creation of an interoperable system by 2023 to facilitate the sharing and gathering of transactional information back to the packaging at the original manufacturer for authorized trading partners or government agents in the event of a suspicious or illegitimate product. How will this system work and what components and governance will be required?

42. An Analysis Of Recent CDER Observation & Warning Letter Data 7/1/2016

    The FDA publishes data on Form 483 inspection observations and warning letters issued by the Center for Drug Evaluation and Research (CDER) during the previous fiscal year. By analyzing this annual data pharmaceutical and biopharmaceutical manufacturers can gain a clearer picture of FDA enforcement trends and their potential impact on business.

43. Bioburden Sources You Might Have Missed 5/3/2017

    A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.

44. Examining Medtech’s Booming Heart Valve Market 8/22/2018

    Transcatheter mitral valve devices will continue to expand into clinical practice as people age out of open-heart surgical operations, and technology and innovation for mitral valve diseases will continue to improve.

45. 4 Steps For Successful Tech Transfer Of Gene And Cell Therapy Products 1/16/2018

    As the gene and cell therapy sector develops and its products start to move from development to commercial manufacture — from smaller or academic establishments and development laboratories to larger facilities with greater capacity — the requirement for the technology transfer of these products will only increase.

46. Managing Medicine’s Most Complex Patient Journey 1/3/2019

    In today’s breakthrough medicines, personalization changes everything. Patients are used to receiving medications. Now, in the era of cell and gene therapies, patients are actually providing the key components to create them.

47. A High-Level Overview of the Proposed Rule To Align FDA’s QSR with ISO 13485 5/13/2019

    The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.

48. Valentine’s Day Heartbreak: How To Let Your (Underperforming) CMO Partner Go 2/12/2020

    We read many articles about building relationships in the business environment to improve transactions, fortify the supply chain, and increase profits. But, what if the CMO has a deteriorating plant that directly impacts your production, or personnel turnover creates an environment of never-ending deviations and senseless retraining?

49. 5 Questions To Ask Your CDMO: #2 – Can You Tell Me About A Project Where Things Went Wrong? 10/2/2018

    Taking a potential drug from candidate selection through clinical development and eventual commercialization is a challenging process. It is not a question of if something unexpected will happen, but when. And when the inevitable problem occurs, how will your CDMO tackle this situation?

50. What's Causing The Rapid Growth Of Prefilled Syringes? 2/28/2017

    Prefilled syringes (PFS) offer significant benefits to patients. The benefits, combined with market trends, and advances in PFS technology, are expected to propel PFS market growth into the next decade.