Featured Pharma Online Editorial

  1. An Analysis Of ICH Draft Guidance Q13: Continuous Manufacturing Of Drug Substance And Drug Products 8/23/2021

    The International Council for Harmonisation (ICH) published a draft version of ICH Q13, Continuous Manufacturing of Drug Substances and Drug Products, for public commentary on July 27, 2021, with the aim of harmonizing the regulatory and quality perspectives of ICH members, including the FDA (U.S.), EMA (EC), and PMDA (Japan).

  2. Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity 8/18/2021

    The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.

  3. Expansion Options For Adherent Cell Therapy 8/4/2021

    While the stirred tank bioreactor is the workhorse of the biopharmaceutical industry, there are applications for which cells can’t be effectively cultured in suspension. Beyond the petri dish and the T-flask, many in our business have not had interactions with the numerous and sometimes niche solutions for adherent cell culture. This article discusses our options in this field.

     

  4. EMA Publishes Guideline On Quality Documentation For Medicinal Products 8/2/2021

    This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.

  5. Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation 7/21/2021

    A robust human factors process is critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.

  6. FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products 7/14/2021

    At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

  7. Emerging Technologies In The Delivery Of Proteins & Peptides 6/28/2021

    The limited ability to selectively deliver new drug molecules in the forms of peptides and proteins remains a significant challenge. Therefore, new materials and manufacturing techniques are emerging to meet the challenges associated with the formulation and delivery of biopharmaceuticals and pharmaceuticals.

  8. Data Integrity In Supply Chain Risk Management During Zero Trust 6/21/2021

    Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.

  9. From Pharma To Biopharma — Education & Workforce Training Programs Converge To Meet Industry Needs 6/9/2021

    The biopharmaceutical industry is poised for a new era of growth, particularly for manufacturing biologics. Workforce development remains a significant limitation, however. This article highlights how the industry workforce training model isn't enough, and what the Albany College of Pharmacy and Health Sciences is doing to address the need for the next-generation workforce.

  10. Outlook: Biotech In 2021 & Beyond 5/31/2021

    Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.