21.02.2024

What about the Third Stage? Continuous Process Validation (CPV)

Authored by Or Degany

In the intricate world of pharmaceutical and biopharmaceutical manufacturing, pharma regulatory consultants emphasize the importance of ensuring consistent quality and regulatory compliance. Continuous Process Validation (CPV) is a critical player in this arena, often recognized as the third stage in the process validation lifecycle. CPV’s primary aim is to demonstrate that a commercial pharmaceutical and biopharmaceutical manufacturing process remains in a state of control post-approval.

Understanding CPV Implementation Challenges

Implementing a CPV program, especially for legacy biopharmaceutical products with a long manufacturing history, poses significant challenges. These products, which have been licensed and manufactured over extended periods, may not initially align with contemporary CPV methodologies. Their process designs may be less rigorous, control strategies less developed, and process parameter classifications not fully accomplished. This gap between older manufacturing processes and current regulatory expectations requires careful navigation.

ADRES: Your Partner in CPV Implementation

At ADRES, we understand the intricacies of implementing CPV in the biopharmaceutical sector. Implementing CPV can be daunting, especially when dealing with legacy products. Understanding the nuances of process control, regulatory compliance, and quality assurance within the CPV framework requires expertise and experience.

If you’re navigating these complex waters, reaching out for expert assistance can make a significant difference.

Whether you are just beginning to explore the world of CPV or want to enhance your existing program, our team at ADRES is here to offer guidance and support. We are committed to helping you understand and implement CPV effectively, ensuring your pharmaceutical and biopharmaceutical manufacturing processes meet the highest quality and control standards.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

26.02.2023

Tangential Flow Filtration Technology

We want to extend a huge thank you to Or Degany from ADRES Int’l Biotech Consultation & Execution and Alessandra Giordano and Eran Gertman from Pall – Biotech for hosting a fantastic webinar on Tangential Flow Filtration Technology. For those who were unable to attend, the recording is available here:

Their expertise in the field was invaluable, providing solutions to practical challenges that are faced by biopharma users in R&D, pilot, or commercial settings. The insights shared, including related regulatory expectations, were insightful and will undoubtedly benefit many in the industry.

Thank you to the team at ADRES and Pall-Biotech for organizing and sharing their expertise with us. We look forward to attending future webinars.

Feel free to Contact us for any questions and consultations, we’ll be happy to assist!

22.02.2023

The end of animal testing in America?

Not so fast…
President Biden created a buzz when he signed a law, eliminating the requirement to test a drug or medical device on animals before testing their effectiveness and safety in humans. But the road is still long and winding, as non-animal technologies still need to be proven as an effective tool for evaluating both safety and effectiveness.
As part of the FDA efforts to support its Toxicology Working Group in advancing the goals of identifying new technologies that could potentially improve toxicity predictivity as well as to support animal 3Rs (Replacement, Reduction, and Refinement), the agency formed the Alternative Methods Working Group. This program focuses on opportunities for evolving and innovative technologies to advance useful tools for testing the effectiveness and safety of therapeutic products, such as microphysiological systems (MPS).

One example of such systems are organoids, self-organized, three-dimensional tissue cultures derived from stem cells, that can divide indefinitely and form tiny structures that resemble miniature organs composed of many cell types. Researchers have been able to produce organoids that resemble the brain, kidney, lung, intestine, stomach, and liver, with many more on the way.
Another subset class of MPS is organs-on-a-chip, which consists of a miniaturized physiological environment engineered to yield and/or analyze functional tissue units capable of modeling targeted organ-level responses.
In contrast to the US, the principle of the 3Rs has been present in spirit in EU legislation, from as early as 1986, and it was made a legal requirement in 2010 in Directive 2010/63/EU.
From our experience and correspondence with both the FDA and EMA, the latter seems much more committed to the 3Rs approach around in vivo testing. The EMA will more often accept proof of concept studies solely based on in vitro or in silico tests and may require only rodents for toxicological studies, not just for biologicals.
Let’s hope the FDA will manage to commit to this advanced approach sooner than we assume 😉

Feel free to Contact us for any questions and consultations, we’ll be happy to assist!

22.11.2022

Attention startups in the bio pharma community!

Last week at Adres we hosted our first LinkedIn Live with over 200 participants

It was great to share our knowledge and experience with the bio pharma community and give you the confidence that you are on the right track with your clinical development program.

In this session, we focused on:

Process Validation and the importance of arriving prepared for this critical milestone

When is the right time to start preparing?

Shifting your mindset to understand the ‘Process is the Product’

Avoiding delays on your critical path

If you weren’t able to join us live, you can still watch the recording here:

Feel free to Contact us for any questions and consultations, we’ll be happy to assist!