Industry Insights
-
Managing Risk For Medical Device Clinical Trials
9/12/2018
This article explains the basics of project risk management and how to execute it, and the vital role clinical data play in product risk management, so the clinical trial manager can be better prepared to both manage risks in their trial projects and participate more fully in the device's product risk management effort.
-
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.
-
Accelerate The Start Of Your Outsourced Pharmaceutical Project
In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a contract development & manufacturing organization (CDMO).
-
Are You Asking Too Much From Your Filler?
10/18/2018
The core mission of the pharmaceutical industry is to manufacture products for patients to cure them, vaccinate them, or alleviate a symptom, often by manufacturing a liquid injectable or an oral solid, among other therapies. In this article, we will focus on the aseptic injectable, from a general standpoint, to see what we are doing with our aseptic filling systems and why.
-
Next Steps For Serialization In The Pharma Supply Chain
7/22/2019
The industry has made unprecedented progress and addressed several challenges to ensure compliance with global pharmaceutical serialization and traceability requirements. While these requirements contain further regulatory milestones on the horizon, manufacturers, distributors, pharmacies, and other parties in the pharmaceutical supply chain must systematically adopt serialization in their normal business operations.
-
Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility
4/8/2022
As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.
-
Simplifying Outsourcing For Complex Formulations
Explore the necessary components of a tech transfer for LNP-based drugs, including the outsourcing strategies needed to avoid pitfalls.
-
Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture
6/18/2018
Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.
-
Snapshot Of The Parenteral Drug Delivery Market
6/17/2022
Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.
-
Manufacturing Biotherapeutics Based On Synthetic Biology: Lessons Learned
7/8/2022
In 2014, Synlogic's co-founders formed the first company that would apply the principles of synthetic biology to the creation and development of biotherapeutics. This article shares their journey in overcoming challenges in producing synthetic biotics, considering new approaches in manufacturing, and the benefits of a hybrid production model.