Our global network of Pfizer scientists, analytical and quality control engineers are here to help you bring your unique gene and cell therapy (GCT) to market. From development to manufacturing, we are here to meet your needs.

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With an approximate 300,000 sq ft of world-class manufacturing space in North Carolina, USA, we provide industry-leading yield and productivity ratios with batches ranging from 200 to 2000 liters.

Discover our manufacturing capabilities

Our infrastructure supports a variety of viral vector types, and we can manufacture AAV vectors across multiple serotypes in the highest quality environment.

Explore our development capabilities

Our team has successful experience with over 40 GMP batches and 100+ transfections in both adherent and suspension cell culture systems.

Discover how our expertise can help you

We use our expertise to help reduce manufacturing suite waiting times, process scale-up time and end-to-end process cycle to streamline production without compromising on quality.

Discover our commercialization strategies

We draw from our Pfizer scientists’ learnings from several years of internal research and pipeline optimization to help troubleshoot quickly and create efficiencies for your innovation.

Let's shape your development masterpiece

Our regulatory experts leverage years of experience in GCT to help overcome roadblocks on your drug’s path to commercialization.

Drive your regulatory strategy with us

As it is a relatively new therapeutic area, meeting the specific needs of GTx development can be difficult. This is especially true because most commercially available equipment and technologies are designed with traditional biologics, such as monoclonal antibodies, in mind.

Extensive expertise and experience are needed to adapt and apply these technologies to meet the manufacturing needs of gene therapy experts.

Developing gene therapies is a complex process.In contrast with traditional biologics, developers must consider unique factors such as full and empty viral vector capsid ratios and triple transfection techniques.

Although developers will anticipate these complexities, the requirements for their analysis are distinct and can be underestimated without the relevant experience of the team – particularly the need to consider analytical volume needs when working with the typically small batches produced.

Early and proactive planning with experienced collaborators in the GTx field is essential to prevent unexpected bottlenecks arising from analytical requirements.

A critical step in viral vector production is triple transfection, in which the three plasmids carrying the genes for vector expression are introduced to the producer cell line.

Scaling this step effectively is critical to preserving a high titer and potency.

Compared with small-scale, large-scale transfection presents risks to quality, consistency and efficiency, and may necessitate input from experts in fluid and mixing dynamics to avoid issues.

With constantly advancing regulations, processes, technologies, and the multidisciplinary nature of GTx projects, communication is key to ensuring compliance and prioritizing patient safety when completing a tech transfer.

The complexities of gene therapy mean that open channels of communication and transparency between the stakeholders involved are required to solidify an understanding of the project’s needs and proactively identify and prevent any risks that could arise during a tech transfer.

GTx development involves unique and complex processes coupled with the need for stringent regulatory compliance to ensure patient safety. Process development and analytical development go hand in hand, with tests needed to determine the impact of process changes on the critical quality attributes (CQAs) of the product.

The need for process and analytical development to occur concurrently can result in potential bottlenecks in production. Preventing these bottlenecks requires drug developers and their contract partners to consider and plan for the likely analytical needs of the entire project from the earliest stage possible.

Accelerating timelines to deliver a GTx to patients should never be at the detriment of a therapeutic’s quality and safety.

Bringing a GTx to market takes the experience and expertise to make judgment calls along the development and manufacturing lines that balance an accelerated timeline and an emphasis on patient safety.

As the scientific understanding of molecular biology and genetics expands, the GTx regulatory landscape must evolve in tandem.

To deliver critical therapeutics to patients who need them, GTx developers and manufacturers must ensure their processes are robust and keep a line of communication open with regulatory bodies.

Leveraging several years of experience from our Pfizer internal research and pipeline optimization in the GTx space, along with an extensive global network of regulatory experts, Pfizer CentreOne can help drive your regulatory strategy and navigate potential roadblocks.

When selecting your CDMO partner, you must consider their facilities, capacity, lead times, capabilities, regulatory strategies, and experience.

As the novel area of gene therapies continues to advance in complexity, one of the most important factors when working with these advanced molecules is expertise. Drawing on a wealth of experience, Pfizer CentreOne understands the unique requirements of GTx projects, proactively anticipates difficulties, and has established strategies to ensure the smooth delivery of projects to key milestones.

Pfizer CentreOne is a CDMO dedicated to executing high-quality GTx products through our unique market offerings:

• Extensive technical expertise in gene therapy

• Clinical to commercial capability with proven quality through our own GMP batch success

• A global network with logistics in place to help your innovation reach patients faster and safely