Featured Bioprocessing Editorial

61. One-Stop Shop Or Best of Breed? 3 CDMO Selection Case Studies 9/8/2020

    Following last week’s editorial by chief editor, Louis Garguilo, Ray Sison, xCell Strategic Consulting, has prepared three case studies and a detailed analysis of the best-of-breed and one-stop-shop outsourcing models. Learn to define a strategy that best fits your product requirements and aligns with your corporate objectives.

62. End Of The Enbrel Battle: How Amgen Beat Sandoz 9/8/2020

    This case serves as a reminder that sometimes it is impossible to fully evaluate the likelihood of success in biosimilar litigation before the challenge begins.

63. Dos And Don’ts Of Virtual Factory Acceptance Testing In Life Sciences 9/3/2020

    Performing virtual FATs (vFATs) can be a helpful solution in these new and uncertain times, though it does come with added risk. Without having the team on-site, remote FATs present a higher possibility for equipment to be shipped without meeting the end user’s requirements and functional specifications.

64. An Update On 2020 U.S. Biosimilars Regulation & Litigation 9/1/2020

    The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.

65. Strategic Outsourcing For Virtual Companies — Lessons From The Trenches 8/31/2020

    A virtual company advancing a drug candidate into product development faces a deluge of challenges. The reality is you do need the assistance of pharmaceutical scientists and advice from industry professionals to help you navigate the twists and turns in the road.

66. Making FMEA More Robust With HACCP 8/27/2020

    Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.

67. Repurposing An Aging Facility To Produce Cell & Gene Therapies 8/24/2020

    Many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies.

68. The Global Regulatory And Quality Environment For Biopharma Outsourcing 8/17/2020

    It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.

69. A Functional History Of Process Validation: Part 2 – The Key To A More Effective Future 8/14/2020

    Part 1 of this two-part series discussed the history and underlying concepts of process validation (PV), which is required for dealing with the increasingly sophisticated pharmaceutical manufacturing processes necessary for realizing advanced medical therapies. This article describes how PV concepts can be evolved so the industry can better develop, manufacture, and launch the next generations of biopharmaceutical products.

70. CBER Takes On More Oversight Of Biologic Biosimilar Master Files 8/11/2020

    For a new biologic product applying for marketing authorization under a biologics license application (BLA), the drug master file (DMF) may be utilized for raw materials, starting materials, and packaging materials, but not for drug substance, drug substance intermediate, or drug product, for reasons that will be discussed in this article.