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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 and Gene Therapies: Risk Management Processes

Mar 22, 2023 11:59:30 AM | In this blog post, we talk about how can you implement Risk Management Processes for Cell and Gene Therapies to every aspect of your product.

Cell and Gene Therapies: Risk Management Processes

In this blog post, we talk about how can you implement Risk Management Processes for Cell and Gene Therapies to every aspect of your product.

Practical Suggestions for ICH Q14 Implementation

The new ICH Q14 guideline is here! How to implement it? We talked with Jean-François Dierick and Claudia Magagnoli on how they did it at GSK.

The new ICH Q13 Guideline is Almost Here!

The new ICH Q13 guideline is almost here! ValGenesis' experts have been actively involved on the public consultation phase and, we have something to say about it.

Business Continuity in Pharma: the Role of Risk Management

Assuring business continuity in pharma can be complex. Effective risk management strategies can help you operate during disruptions.

QRM Over Lifecycle Management

Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.

Tech Transfer: Planning for Success

Tech Transfer is especially important. When switching facilities, you want to transfer the knowledge and reproduce the process smoothly.

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.

Biosimilars Approval: how to Reduce Time to Market?

In this blog post, we tell what the most effective approach for your biosimilars approval to reduce its time to market is.

Adopting Continuous Manufacturing (CM): The Case of Biologics

Continuous Manufacturing brings quality and delivery many business gains when applied to biologic products.

Cell and Gene Therapy: the Benefits of PAT and QbD

Cell and Gene Therapy products are considered the future of medicine. PAT and QbD can bring many benefits to C>

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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