The cell and gene therapy (CGT) industry is transforming medicine, offering groundbreaking treatments for conditions once thought to be untreatable. From engineered CAR-T cells that combat cancer to gene therapies that correct genetic disorders, the success of these innovations depends on meticulous manufacturing processes. Every component in the development pipeline plays a critical role, and excipients—non-active ingredients that stabilize, deliver, and enhance the performance of these therapies—are fundamental to achieving the safety, efficacy, and scalability required in CGT manufacturing.
Excipients serve as the backbone of final therapeutic products, ensuring stability, consistency, and functionality. In the case of cell and gene therapy, excipients like buffers, media, cryoprotectants, media supplements, and reagents play a vital role in maintaining the integrity of therapeutic cells, facilitating the delivery of genes, and stabilizing viral vectors. Unlike traditional pharmaceuticals, cell and gene therapy products are highly complex and sensitive to environmental conditions, which makes the quality of excipients more critical than ever. Any inconsistency or variability in excipients can disrupt manufacturing, delay clinical timelines, or compromise patient safety. By using excipients that adhere to Excipient GMP standards, CGT developers can ensure consistent, reproducible performance across the product lifecycle, from research and development to clinical trials and commercial production.
At Nucleus Biologics, we recognize the importance of excipient quality and its impact on the CGT development process. To reinforce our commitment to providing materials of the highest standard, we are proud to announce our recent certification to EXCiPACT for Pharmaceutical Excipients and Pharmaceutical Auxiliary Materials (PAMs) and ISO 9001 certification. These prestigious certifications, in addition to our ISO 13485 certification, underscore our dedication to delivering GMP-quality excipients that meet stringent regulatory requirements, simplify manufacturing, and ultimately improve patient access to life-saving therapies.
The EXCiPACT GMP Standard is a globally recognized certification that verifies compliance with rigorous Good Manufacturing Practices (GMP). Designed specifically for Pharmaceutical Excipients and Pharmaceutical Auxiliary Materials (PAMs), it sets the highest standards for quality, safety, and supply chain integrity. Achieving this certification requires manufacturers to undergo independent third-party audits that evaluate every aspect of their production process, from raw material sourcing and risk management to supply chain traceability and manufacturing controls. This ensures that excipients meet the same stringent quality standards as active ingredients and final drug products.
This certification is highly respected across the pharmaceutical and biotechnology industries and aligns with the expectations of leading regulatory agencies, including the FDA and EMA. For therapy developers, working with EXCiPACT-certified companies means they can trust in the quality of their supply chain without the need for extensive supplier audits. This not only saves time but also ensures confidence in the materials used to produce life-saving therapies. By meeting EXCiPACT for Pharmaceutical Excipients and Pharmaceutical Auxiliary Materials (PAMs), Nucleus Biologics has demonstrated our ability to consistently provide excipient materials that are safe, reliable, and ready to support CGT manufacturing.
High-quality excipients play a pivotal role in accelerating CGT development. They help streamline regulatory filings by providing comprehensive documentation that satisfies global standards, reducing the time and effort required to gain regulatory approval. They also enable a seamless transition from research to clinical and commercial manufacturing by ensuring batch-to-batch consistency and reliable performance. For CGT developers, this reliability is critical, as any variability can lead to manufacturing delays, increased costs, or compromised product quality. Using Excipient GMP quality materials mitigates risks of contamination and variability, allowing manufacturers to maintain the integrity of their processes and products.
Beyond enabling development efficiency, excipients also have a direct impact on patient access. The complexity of CGT manufacturing is a significant barrier to making these therapies widely available, as high costs and long production timelines can limit scalability. By ensuring reliable and high-quality excipients, Nucleus Biologics helps therapy developers reduce costs, minimize delays, and bring their therapies to market faster. This not only accelerates the availability of life-changing treatments but also makes them more accessible to patients in need.
The EXCiPACT certification is more than a quality standard—it reflects our commitment to driving innovation and supporting the CGT community. By ensuring that our materials meet the highest global benchmarks for quality and compliance, we empower therapy developers to focus on what matters most: advancing transformative therapies for patients. Our Excipient GMP materials provide the consistency and reliability needed to meet regulatory requirements, improve manufacturing efficiency, and deliver safe and effective therapies to patients.
At Nucleus Biologics, we take pride in being a trusted partner for CGT developers, offering solutions that support their success at every stage of the development process. With our EXCiPACT certification, we continue to lead the way providing Excipient GMP quality materials in order to help accelerate development timelines, reduce risks, and enable the future of medicine.
Learn more about how Nucleus Biologics is supporting cell and gene therapy innovation with Excipient GMP quality materials by visiting our website.
