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Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.

Latest News

Cell & Gene Therapies: is Quality by Design Ready for it?

Apr 20, 2023 10:43:33 AM | In this blog post, we want to discuss about the application of the Quality by Design for Cell & Gene Therapies. Are they suited for them?

Posts about Product Development:

Cell & Gene Therapies: is Quality by Design Ready for it?

In this blog post, we want to discuss about the application of the Quality by Design for Cell & Gene Therapies. Are they suited for them?

Challenges on Comparability Studies on Early Development Stages

This blog post goes over the key aspects of developing solid comparability studies on early development stages.

Developing a Drug Product Using QbD: a ValGenesis Story

This story is about our project with Libbs Farmacêutica to successfully apply a QbD framework in the development of an oral drug product

Cell and Gene Therapy: How to Minimize its Risks?

There are still some challenges when it comes to minimizing the risks in Cell and Gene Therapy. Here, we give some thoughts on how to manage and minimize them.

Accelerate Time-to-market Using a QbD Framework: a ValGenesis Story

We write about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework

Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

Root-Cause Analysis

Finding the Root Cause in mAB Production: a ValGenesis Story

Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.

Sofia Santos

Written by
Sofia Santos

How to Accelerate Process Scale-Up With Effective Tech Transfer

Process Digitalization

How to Accelerate Process Scale-Up With Effective Tech Transfer

There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.

Sofia Santos

Written by
Sofia Santos

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Quality Risk Management

Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis

Read the industry insight on the topic of Quality Risk Management

Sandra Silva

Presented by
Sandra Silva

Trending Topics With ValGenesis Customers

CSV and the Shift to CSA

CSA flips the paradigm of traditional CSV to "right-size" validation processes. Learn more about the benefits and principles of the CSA approach, which encourages critical thinking and automation.

Previously

CRO AmplifyBio Accelerates Trial Success with Digital CSV

Risk-based CSA Validation: Ensuring the Least Burdensome Approach

Cleaning Validation

Learn how digitization offers a consistent way to carry out cleaning validation lifecycle activities, ensuring your methods and procedures are risk-based and rooted in scientific evidence.

Previously

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

Maximize the Use of Technology to Access Real-Time Clean In Place Data

Pharma 4.0

Waves of new technology and thinking — IoT, AR, cloud, Agile — are transforming the very foundation of validation processes. Learn how to leverage them in a Pharma 4.0 world.

Previously

The Pharma 4.0 Vision for Manufacturing Intelligence

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