Analytical Methods Archives - WuXi Advanced Therapies

Why it Matters

Transferring potency assays is a complex but crucial process in the development and manufacturing of biological products, particularly in the realm of cell and gene therapies (CGTs). These assays play a vital role in ensuring product efficacy, quality, and stability. Unlike biosafety assays, potency assays must be specifically designed for each product, making their transfer process highly specialized.

As a Contract Development and Manufacturing Organization (CDMO), WuXi Advanced Therapies has extensive experience in handling assay transfers from a wide variety of sources at various stages of development. To ensure a seamless transition, we have identified five key factors that can significantly impact the success of potency assay transfers.

Five Key Considerations for Potency Assay Transfers

1. Timeframes

Establish realistic timeframes that balance speed and quality.

Setting achievable timelines is essential for a successful potency assay transfer. Factors such as standard operating procedures (SOPs), training, scaling, documentation, equipment validation, and regulatory implications must all be considered. Later-phase or commercial potency assays may require additional qualification and validation. Involving key stakeholders and subject matter experts from both parties ensures a well-informed timeline that aligns with project goals.

2. Agreements

Define clear agreements with detailed scopes and documented expectations.

Each potency assay transfer is unique, requiring a well-documented collaboration between involved parties. Work Orders (WOs) and Master Service Agreements (MSAs) should outline roles, deliverables, pricing, payment terms, and intellectual property concerns. Clearly documenting changes and amendments throughout the transfer process fosters transparency and accountability.

3. Training

Implement a comprehensive training plan tailored to varying experience levels.

Potency assays rely on diverse scientific technologies that require specialized training for GMP laboratory execution. Hands-on training, documentation reviews, and trainer-to-trainer sessions are all crucial components. You can improve knowledge transfer and consistency in execution by adopting flexible training approaches, such as on-site training by expert trainers or laboratory scientists visiting the originator lab. Establishing clear acceptance criteria and performance assessments will help ensure your training programs are effective.

4. Material Readiness

Secure critical reagents and establish a robust sourcing strategy.

Supply chain disruptions can significantly impact potency assays, affecting clinical and commercial product timelines. Early planning for sourcing essential reagents and qualifying suppliers can mitigate these risks. Additionally, in-house production of critical assay reagents, such as reference controls, ensures a steady supply and minimizes delays.

5. Communication

Develop a structured communication plan with escalation paths and regular updates.

Transparent, proactive communication is key to successful potency assay transfers. Establishing a clear cadence of meetings for cross-functional teams and stakeholders helps address potential issues in real-time. A well-documented communication plan, including escalation paths and communication trees, prevents misunderstandings and ensures smooth knowledge transfer.

The Bottom Line

Transferring potency assays is a critical step in the development and manufacturing of biological products, especially for CGTs. Ensuring success requires careful planning, clear agreements, effective training, proactive material readiness, and structured communication. By addressing these five key considerations, organizations can streamline potency assay transfers, minimize risks, and enhance overall product quality and regulatory compliance. As an experienced CDMO, we are committed to supporting seamless potency assay transfers for clinical and commercial success. Contact us today to discuss the future of your program.

Where Can I Learn More?

If you’d like more insight into improving your approach to tech transfer of a cell potency assay or potency assay development, Dr. Audrey Chang, Executive Director and CMC Scientific Advisor and Joseph Newcome, Senior Director, Analytical Development, recently hosted a webinar in which they discussed how to overcome the challenges the industry faces when developing potency assays for cell and gene therapies. You can watch the full webinar or contact us to speak with our experts directly.

To launch a successful GMP program for biologics, a robust quality control (QC) release testing protocol is essential. QC testing, which is mandated by global regulatory authorities, helps ensure that a product meets scientific specifications and reaches patients safely. Though each program will have unique parameters, QC testing should gather data to answer the following questions:

Identity: Have you produced the correct product?
Purity: What manufacturing and product byproducts are present?
Strength: What is the potency and quantity of your product?
Safety: Is your product safe and free of unwanted adventitious agents, e.g. Virus, bacteria, and mycoplasma?
Product Quality Attributes: Have you demonstrated that product specific attributes are present?

As biologics continue to diversify beyond monoclonal antibodies (mAbs) and recombinant proteins to include cell and gene therapies (CGTs), QC programs are shifting to accommodate the unique challenges associated with these advanced and novel therapeutics.

Recognizing Important Shifts

CGTs require adaptive and advanced assays for characterization and safety assessments; in many instances, the assays historically used for biologics do not fit the needs of these novel therapies. For example, mycoplasma has long been an area of key testing concern due to its ability to pass through standard sterilization filters. The standard mycoplasma culture-based assay takes 28 days to complete. This cycle is incompatible with the short shelf life of CGT products; as a result, the industry has pivoted to PCR testing for mycoplasma in CGTs, which can be completed in just a few days.

Empty/full ratios for viral vectors are another critical quality characteristic that has been challenging to characterize in the GMP setting thus far. To date, Analytical ultracentrifugation (AUC) has served as the best assessment of empty, full, and partial populations on the market, and as the identification of these ratios grows increasingly vital, AUC will continue to be an important implement for QC programs.

Several other considerations, including defining the critical quality attributes of raw materials and navigating evolving regulatory guidance, have left CGT developers and manufacturers looking for greater insight into how best to design their QC approach.

Identifying Five Best Practices for QC Programs

As you strive to design a strategic QC program, assess how you can leverage the following five best practices in your approach:

Align to Your Risk Assessment:To mitigate risk, begin with a GMP mindset from the start, including sourcing well-characterized cell lines and raw materials while accounting for scale in your processes.
Take a Quality by Design (QbD) Approach: Implementing QbD processes entails several deliberate choices, including ensuring you have the inventory necessary for your product lifecycle, creating a reference standard, and tracking trends as you set specifications.
Leverage Templates and Platforms: Utilizing a templated or platformed approach helps you minimize variation in your process and establish streamlined validations, defined assay parameters, and a thorough understanding of each step.
Gain Proximity to the Manufacturing Floor: The closer the QC lab’s proximity to the manufacturing floor, the better. The goal is to implement real-time, continuous testing in parallel with your manufacturing process.
Participate in Knowledge Sharing: Disseminating key findings between stakeholders across the industry ― particularly around data, technology, and regulatory interactions ― yields major benefits for everyone, including patients.

Where Can I Learn More?

If you’d like more insight into improving your QC program, Dr. Audrey Chang, Executive Director at WuXi Advanced Therapies, recently hosted a webinar in which she highlighted the difficulties of developing QC programs for CGTs and her recommendations for how to improve them. You can watch the full webinar here or contact us to schedule a time to speak with her directly.

Tag: Analytical Methods

Transferring Potency Assays from Lab to GMP Production: 5 Key Strategies for Success