Newsletter | June 25, 2020

06.25.20 -- What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks

Featured Editorial
Industry Insights
Approaches To Improve Efficiency In Biopharmaceutical Process Development

Time-to-experiment, time-to-clinic, and time-to-market are all becoming even more important for developers and manufacturers of biopharmaceuticals. Here, we give some insights on tools to make process development more efficient.

Lyophilization Of Highly Potent Drugs: Facility And Equipment Design Elements

Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.

Can mRNA Disrupt The Biopharma Industry?

mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.

A Guide To Cleanroom Construction Methodologies

Your future cleanroom is a critical asset; it is not just another construction project. The investment you make in the cleanroom facility is significant and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

First-In-Human Trials: A Make-Or-Break Milestone For Small Biopharmas

Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into first-in-human (FIH) testing is essential. But, how?

The Challenges Batch And Continuous Manufacturing Bring To Containment Product Design

Methods and techniques used in pharmaceutical manufacturing are broadly reviewed. There are two basic models of pharma manufacturing: batch and continuous. Both approaches are defined. It is concluded that both approaches have elements of the other. Generally speaking, many pharma manufacturing procedures are transitioning from the batch to the continuous approach.

The Hidden Costs Of Multiple-Vendor Contract Manufacturing

When it comes to outsourcing in medical device manufacturing, companies are faced with the decision to either use a selection of unrelated service providers or a single-source contract manufacturer that can handle every step of the process. This article discusses the consequences and the advantages of working with a single-source contract manufacturer.

Choose Between Infrared And Thermal Conductivity Co2 Sensors In Incubators

This paper compares the two main technologies for measuring CO2 — infrared (IR) and thermal conductivity — and examines which technology might be best for a given laboratory.

8 Key Factors When Selecting A Powered Air-Purifying Respirator System

This white paper explores eight considerations in detail and could be helpful to environment, health, and safety (EHS) managers and supervisors looking to select a powered air-purifying respirator system for their particular application.

The Supply Chain Executive’s Perspective On Single-Supplier CDMOs

A single vendor offers access to a network of experts who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. 

Replace Dye Ingress With Mass Extraction To Mitigate Risks

A major pharma company had a problem. Its manufacturing process engineers could not reliably verify that pouch packages were sealed properly. Product could potentially ship with questionable packaging.

Strategies For Optimizing Upstream Processes Cell Culture

The cell culture process is crucial for maximizing the production of biologics and vaccines, optimizing product quality attributes, minimizing impurities, and simplifying operations.

The Impact Of Dissolution On Particle Size And Particle Shape Of Multicmponent Drug Delivery Systems

The particle size and particle shape of multicomponent controlled release drugs must be considered during their dissolution. Though the size and shape of the particles are well known during formulation and manufacture, oftentimes little is known about the changes in size, shape, and morphology during dissolution.

Webinar: Navigating EU Product Launch Milestones

Throughout this webinar we will share our knowledge and experience of various EU regulatory filing options focusing primarily on the centralized procedure. This webinar will help you navigate the various EU regulatory filing options to allow you to plan ahead and save time in what can be a lengthy and complicated process.

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