Newsletter | September 7, 2021

09.07.21 -- 5-Step Checklist For A Robust Quality Management System

 
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Industry Insights
Is Your Biologics At Risk For Protein Aggregation? Part 1

This is the first installment in a three-part series that examines the causes of protein aggregation and practical steps you can take to mitigate the risk.

Meeting The Challenge Of Delivering High-Volume Biologics Therapies

As the industry moves toward self-administration to reduce healthcare costs and improve patient convenience, there is a compelling need for simple-to-use, low-cost disposable devices.

How Client Forecasts Support Integrity Of The Biopharma Supply Chain

Receiving customer forecasts as early and as completely as possible is critical to the success of the supply chain continuum.

Five Key Tips To Enhance The Solubility Of Your Oral Drug Products

This article discusses five key factors that companies should keep in mind to help ensure their path to solubility enhancement is as seamless and as low risk as possible.

How Batch And Continuous Manufacturing Impact Containment Product Design

There are two basic models of pharma manufacturing: batch and continuous. Generally, many pharma manufacturing procedures are transitioning from the batch to the continuous approach.

Standardizing Vein-To-Vein Logistics To Reach More Patients

Collaboration is key to solving data management and process variability challenges as stakeholders work toward a common goal — getting life-saving treatments to those who need them.

Powder-In-Capsule Microdosing Accelerates Drug Product Development

A key tool to address tight timelines and complex molecules is precision powder microdosing in capsules, which makes it possible to quickly get formulations to the clinic.

Insight From An Expert: A Chemist’s Secrets To Efficient API Scale-Up

The more efficient your API synthesis, the lower your cost of goods. The author shares his tricks of the trade for route selection, equipment choice, manufacturing techniques, and more.

Regulatory Services For Accelerated Development And Commercialization

The increase in breakthrough therapy designations and other allowances for expedited regulatory review has led to ever more innovative drug products being developed under shortened timelines. 

Cleanroom Design And Installation

What if you were to learn that modular cleanrooms are also more cost-effective, less risky, more sustainable, and more compatible with your manufacturing process now and in the future?

Leveraging Infrastructure And Innovation To Accelerate Biologics Development

With a growing pipeline of regenerative biopharmaceuticals and increasing approvals for biologics, we need available solutions that translate the promise of a remarkable discovery into a therapy.

Essential Up-Front Planning For Your Clinical Trial

Early planning can optimize key parameters for study supplies, including risk mitigation strategies that minimize waste with optimized inventory and demand forecasting to facilitate supply planning.

Rapid Developability Assessment Of Early-Phase Molecules

A case study that illustrates how to use PBPK modeling, the developability classification system, and the biopharmaceuticals distribution classification system to facilitate the development of a molecule.

Aseptic Filling Of Dry Powder And Liquid In Dual Chamber Syringes

The trend toward prefilled disposable syringes, whether of the single- or dual-chamber type, is increasing. This webcast concentrates on the aseptic pharmaceutical packaging process challenges that need to be addressed in the final filling process of dual-chamber syringes, where both liquid and powdery substances are mixed by the patient immediately prior to injection. This practice shows clear advantages as it can eliminate preservative needs while enabling longer shelf lives.

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