NEWS

Optimizing your post-approval changes to save time, resources and money

9 January 2024
Drug Substance
Isabelle Lequeux
Program Manager – Regulatory Lead

When developing a control strategy for a manufacturing process, two options are typically available to the license holder: a tightly controlled strategy based on the manufacturing process being repeated as closely as possible to the registered process, which is the strategy that has been widely and successfully used for the manufacture of biologics for many years. A drawback of this approach is limited flexibility to change the process.

The second option is to define a Quality by Design (QbD) control strategy based on product and process knowledge and understanding. This option typically requires development activities and registration of the manufacturing process that demonstrates an understanding of the impact of the different process steps, attributes, and parameters on product quality. 

This latter approach has not been universally implemented by the biologics industry to date, as it is also perceived that it will increase the resources, materials, time, and costs associated with development activities. This is not always compatible with the finite resources of the industry and the accelerated timelines needed to meet patient demand as quickly as possible.

A benefit of the QbD approach is that changes to the manufacturing process have the potential to be more easily implementable – not from a technical point of view (the same technical justification to ensure the change does not impact product quality will be expected) but from a regulatory point of view.

Some BioPhorum member organizations have also successfully used the QbD tools to register the controls associated with manufacturing processes and have come together to summarize their best practices for initial submissions. 

The team then added their best practices for post-approval changes that can be used throughout the product lifecycle, especially when the initial submission did not include QbD principles.

The paper Best regulatory practices for lifecycle management – registration of manufacturing controls is a collection of best and successful practices that can save time, resources, and costs, and simplify and continue the supply chain when faced with post-approval changes. 

When implemented, these best practices will allow you to minimize the number of post-approval regulatory notifications to regulators and reduce the variation categories associated with product lifecycle changes.

Aiming for flexibility

Our paper summarizes the systematic approach industry uses for demonstrating product and process knowledge and defining the appropriate process controls that will allow future flexibility. The approach uses the regulatory tools available, especially the most recent ICH quality guidelines.

The desired state is to build regulatory flexibility into dossiers to reduce the burden of post-approval changes while enhancing the definition of product quality and promoting our industry’s agility and adaptability to meet patient needs.

The paper can be used by mature regulatory organizations as a reference to confirm that they are using all the regulatory tools available. Less regulatory-mature organizations and new regulatory professionals are encouraged to consult the paper to establish best practices based on industry successes.

BioPhorum members can add the paper to their toolbox of best practices and training materials. The team also plans to discuss implementing the guidance with the Drug Substance, Fill Finish, and Development Group Phorums.

This is the second paper of the BioPhorum series on regulatory best practices for the lifecycle management of biopharmaceutical products and follows The four steps for registering innovative and complex raw materials. The next paper in the series will look at the registration of analytical methods.

For more information, download the paper here and contact Isabelle Lequeux, Regulatory Lead, Program Manager and Global Change Facilitator, at isabelle.lequeux@biophorum.com

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

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Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

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Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

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Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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