Featured Bioprocessing Editorial

51. Buyer Beware! Pharmaceutical Equipment Suppliers, Promises, & Delivery 9/30/2020

    Our industry depends on a wide spectrum of equipment suppliers that provide our manufacturing systems, utility systems, and environmental systems. This article raises a number of points to discuss with equipment suppliers and your facility engineers to plan for and assure a successful and compliant installation.

52. Weighing The Potential Of Humira Biosimilars In The U.S. 9/29/2020

    This two-part article series explores the factors differentiating the Humira (adalimumab) biosimilar market from that of infliximab biosimilars, which could lead to stronger uptake of these products in the U.S. In Part 1, we focus on the unique competitive dynamics within the adalimumab biosimilar market.

53. ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices 9/28/2020

    This article discusses two longstanding ASTM standards on cleanability testing for use in the oxygen service industry that have been updated for use in cleanability testing for the pharmaceutical and medical device manufacturing industries.

54. Hazmat Regulations: What Life Sciences Companies Need To Know 9/25/2020

    It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.

55. Can We Eradicate Tech Transfer? 9/23/2020

    While warp-speed manufacturing is a pandemic term, the concept is important to the FDA’s 21st century vision of “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive oversight.” Reaching 21st century performance requires replacing many 20th century practices.

56. Operationalizing Cell & Gene Therapy: Challenges And Solutions 9/22/2020

    Cell and gene therapies require operational excellence, complex manufacturing processes, and enormous investment, among other challenges. This article highlights some of these challenges and presents real-world evident solutions.

57. Generate The Right Input Data For A Quality Management Review System 9/21/2020

    In this part two in a series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems, we turn our attention to the input data for an effective quality management review.

58. FDA Releases Guidance On Normal GMP Operations During COVID-19 9/18/2020

    Most FDA guidance on COVID has been associated with tools to combat the pandemic. This new guidance should be read by all drug and biologic manufacturers, whether or not they produce COVID-related products.

59. "Quality Culture" And CGMP Compliance: The Perception-Vs-Reality Gap 9/16/2020

    This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

60. Unpacking FDA’s New Guidance On Controlling Nitrosamine Impurities In Drugs 9/10/2020

    On Sept. 2, 2020, the Federal Register announced the availability of a final FDA guidance, "Control of Nitrosamine Impurities in Human Drugs." This guidance is immediately effective and was not subject to the usual comment period “…because of the importance of providing timely information to manufacturers regarding risk assessments, testing, and other appropriate actions they should take."