Your gene and cell therapy innovation brought to light

Time is life and experience is key with gene and cell therapy, so choosing the right CDMO partner is critical.

At our Sanford site, we have a team of gene and cell therapy scientists and manufacturing experts, who have the experience in developing and manufacturing scalable viral vectors across multiple serotypes, in a significant number of GMP batches with proven quality control.

Our extensive network of global regulatory experts, analytical and quality control engineers, means that we can help you overcome bottlenecks and troubleshoot. We are ready to help ensure your innovation reaches your patients fast.

Speak to our gene and cell experts today

Expert content

Gene and cell therapy analytical and development methods: A path to success

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What to look for in a gene and cell therapy CDMO partner

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Watch the Gene and Cell Therapy webinar

Watch the Webinar

Pfizer CentreOne gene therapy webinar

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Uncover unique insights from Pfizer scientists into how process, methods, and platform factors light up the path to gene therapy success, driving optimized yields, accelerated timelines to market, and more reliable manufacturing outcomes.

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What makes Pfizer CentreOne's gene and cell therapy altogether different

Technical expertise

Global team of 70+ experienced Pfizer scientists
Global network of manufacturing, analytical and quality experts
Several years of experience from our Pfizer internal research & pipeline optimization
Developing and manufacturing scalable viral vectors across multiple serotypes
Adherent and suspension cell culture process

Capability & quality

Clinical to commercial capability
Single use mobile equipment
Infrastructure to support multiple viral vectors
Industry leading yield & productivity ratios to meet the need of your targeted vector tissue
Batches ranging from 200-2000 liters
Over 40 GCP batches & 100+ transfections

Time is life

Global network of Pfizer scientists, regulatory experts, and analytical & quality control engineers that help reduce:

Waiting times for manufacturing suite access
Process scale-up time
End-to-end process cycle time

Process development

Your gene and cell therapy is innovative and needs the right process development methods and analytical requirements to support this.

At Pfizer CentreOne we understand the importance of the right processes in meeting your critical development milestones.

This is why your innovation will have the development support of not only our 70+ US based scientists, but also a global network of analytical and quality control engineers, as well as regulatory experts who can support you along your journey.

Manufacturing

With approximately 300,000 sq ft of state of the art gene and cell manufacturing in North Carolina - USA, we are ready to meet your needs. We use single use mobile equipment to enable rapid turnover and platform customization.

We have the capabilities of industry leading yield and productivity ratios to help meet the need for your targeted vector tissue; with batches ranging from 200 -2000L. Together with filling, packaging and cold chain storage & shipping solutions.

This is how our Pfizer CentreOne value chain is designed to help you scale up your gene and cell therapy innovations from clinical to commercialization.

State of the art facilities

sanford

Our primary site in Sanford - North Carolina, USA:

Employs over 1,400 colleagues
35 years in operation
Highly skilled workforce with patient focused culture
Sustainably-focused energy and utility systems
Warehousing with multiple temperature storage conditions

Discover Sanford

Our science experts

Sriram Srinivasan

Sr. Director for Gene Therapy Process Development at Pfizer

Sriram leads teams to develop drug substance manufacturing processes; this includes the development of transfers processes and technologies to enable clinical and commercial-scale manufacturing while seeking to increase productivity and consistency to enable this emerging modality. Prior to this, Sriram has over 15 years of experience in upstream development for therapeutic proteins and vaccines.

Sriram is a biochemical engineer with a bachelor's from Anna University, India and a PhD from Dartmouth College, USA.

Bianca Bracht

Global Lead in Supply Manufacturing for Clinical Gene Therapy

Bianca oversees a team responsible for the project management, tech transfer, and end-to-end manufacturing of clinical gene therapy products. Indications of products she has been directly involved with include Hemophilia, Duchenne’s Muscular Dystrophy, and Wilson’s Disease.

Bianca holds a BSE in Biomedical Engineering as well as a Global Executive MBA from Duke University.

Helena Vitello

Senior Manager, Analytical Technologies

Helena leads the Analytical testing team and support numerous teams across the process, including the MSAT team with routine and characterization testing, manufacturing team with investigations and non-GMP testing, and Quality control team with investigations, as well as method troubleshooting and redevelopment activities.

Helena holds a Ph.D. in Biochemistry and Molecular Biophysics, University of Pennsylvania

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.

Let's work together

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

Why Pfizer Infographic

Let's light up your gene and cell therapy together

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Frequently asked questions in
gene therapy development and manufacturing processes

The gene therapy (GTx) market is expanding rapidly, fueled by the potential of these revolutionary medicines to treat diseases ranging from various cancers to rare disorders. With over 2,000 gene therapies currently in development pipelines¹, the market is expected to climb in value, from $18.61 billion in 2022 to around $93.78 billion by 2030 at a compound annual growth rate of 22.41%².

Bringing these life-changing therapies to market — and ultimately to the patients who have been waiting for transformative therapies like these — is a complex process.

Here, our Pfizer gene therapy experts answer key questions around the development and manufacturing processes of GTx.

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

Frequently asked questions in gene therapy development and manufacturing processes