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Articles by Joe Hoff
06.06.23 -- FDA Adopts ICH Guidance On Biodistribution Of Viral Vectors
By Tim Sandle, Ph.D. An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.
05.25.23 -- All You Need To Know About Contamination Control Strategies, Part 1
A conversation with Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Quality Executive Partners In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, .
04.14.23 -- Final Guidance Locks In FDA's Definitions For Suspect And Illegitimate Drug
By Holly Brevig, Ph.D. With a Drug Supply Chain Security Act deadline looming, the FDA published its final guidance clarifying terms the agency uses to describe illegitimate and suspect drug product.
04.05.23 -- Cell & Gene Best Of March
Hello readers, I’m happy to bring you March’s most-clicked articles. Enjoy! Erin Harris, editor in chief
02.23.23 -- What Is Contributing To The API Shortage?
By Anna Levchuk and Molly Bowman, Clarivate No, you can’t have your cake and eat it, too. In this case, your “cake” is a six-cents-worth generic pill. We have seen a precarious competitive situation with generic drug manufacturing for several years now; what are the key trends and their impacts on the pharma supply chain? Let's investigate.
12.15.22 -- The Future of iPSCs
By Tim Sandle, Ph.D. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending Jan. 14, 2023) and through the EMA (ending Feb. 10, 2023).
11.22.22 -- India's New Drugs Draft Bill 2022
By Mathini Ilancheran, principal analyst, R&D, Beroe Inc. To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?
11.04.21 -- Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd. While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices. Article | By Joe Hoff, Automated Systems of Tacoma, Inc.
09.23.21 -- Gene Therapies for Spinal Cord-Related Diseases
By Moria Feighery-Ross and Wai Wong, Pharmatech Associates Cell therapy production is cost-prohibitive due to the limited manufacturing space and number of personnel required. Enter the "factory-in-a-box," which can be a game-changer for the industry. By Cell & Gene Karen Kozarsky, Ph.D., cofounder, and CSO of SwanBio, explains how the company is pioneering a deep and varied pipeline of gene therapies for genetically defined neurological diseases with a focus on the spinal cord.
07.16.21 -- Overcoming Challenges In Delivering Proteins & Peptides
Article | By Joe Hoff, Automated Systems of Tacoma, Inc. This article describes how the advantages of AST's GENiSYS® system can streamline the tech transfer process by enabling efficient drug development activities and process data collection. Article | By Hemi Sagi, Pfeiffer Vacuum Inc. Mass extraction tests are nondestructive and offer higher measurement sensitivity. In addition, the instruments are efficient, offer short test times, and are more accurate than many of the other methods.
Your Prep Sports Area Alumni Report: Solon Graduate Bock Named MVFC Defensive Player of the Week - Your Prep Sports
Solon Ryan Murken Follow @rmmurken Adam Bock, Alumni Report, Cam Miller, Joe Hoff April 19, 2021 Ryan Murken Your Prep Sports The Your Prep Sports Alumni Report is a weekly segment that recognizes the accomplishments of graduates from YPS area schools that are continuing their careers as student athletes at the collegiate level. Alumni News is a way for readers to keep tabs on former area standouts as well as honoring those athletes that continue to excel at the next level.
05.21.20 -- Should You List All Manufacturing Facilities In Your Drug Application? A Question Of Regulatory Ethics
Newsletter | May 21, 2020 By Ketan Agravat, rK3 Solutions In this second installment of a two-part article, we will review the importance of listing all appropriate manufacturing facilities in the drug substance section of a drug application and discuss the role of regulatory professionals in ensuring that the necessary information is included in the application. By Allan Marinelli, Quality Validation 360 Inc.
04.09.20 -- Remote Auditing Best Practices For GMP Compliance
Newsletter | April 9, 2020 Sponsor Remote Auditing For GMP Compliance During COVID-19: Challenges And Opportunities April 16, 2020 | 1:00 PM EDTM Ensure your GMP audits and compliance don’t suffer due to COVID-19 restrictions.
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