Production Featured Articles
-
Is The U.S. Ready For A Re-shored Pharma Supply Chain?
7/2/2020
In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.
-
Are We Adequately Assessing U.S. Pharma Supply Chain Risks?
6/26/2020
There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.
-
Curing Your Complex Oral Solid Dose Challenges - Q&A
6/16/2020
Pfizer CentreOne’s oral solid dose experts Amy Trotch and Kieran Coffey’s webinar on engineering advancements for complex Oral Solid Dose (OSD) coatings offered insight into the range of coating techniques and technologies available today, and how these coatings can be scaled and transferred effectively for commercial manufacturing. Here you will find a transcript of the Q&A portion of the webinar.
-
Oral Solid Dose Regulatory Hurdles And How To Approach Them
6/16/2020
In your quest to meet the regulatory requirements for your oral solids project you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. In this blog experts discuss common regulatory challenges and how to approach them.
-
How Oral Solid Coating Technologies Can Enhance Delivery Strategy
6/16/2020
Oral solid dose (OSD) remains a dominant form in drug delivery and development and there are continual advances to improve oral solid stability, integrity and robustness through technology platforms, including coating technologies. This blog discusses the strategies and coating technologies that can aid complex OSD formulation.
-
What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks
6/12/2020
This article describes how the basic principles of managing personal risks of being infected by a respiratory virus can be used to manage risks for developing and manufacturing pharmaceuticals. The goal is to elucidate the basic principles of understanding, managing, and communicating a wide variety of risks from the trivially simple to the very complex.
-
After COVID-19: Time To Rethink, Redesign, & Reprioritize Everything
6/8/2020
As we navigate the uncertainty ahead, two things are certain: 1) We will get through this, and (2) the post COVID-19 environment will be very different — but will it be better?
-
Knowledge Management — Opportunities & Challenges For Legacy Drug Products
6/1/2020
This article will explore specific challenges of managing knowledge in a legacy manufacturing environment and propose viable, practical solutions that have been found to be effective. These solutions allow practitioners to increase product and process understanding as well as performance.
-
2 (Major) Impediments To Faster Biopharma Product Development
5/29/2020
As pharma products have become more complicated, companies have become bogged down in accomplishing their mission of launching new products because of complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to patients.
-
Put Your Continued Process Verification (CPV) Data To Work
5/22/2020
Though the FDA’s process validation guidance has been in place for over a decade and other regulatory agencies (EMA, WHO, PIC/S) continue to accept the continuous process verification (CPV) concept, adoption has been slowed by the data governance, analytical capability, and technology challenges.