Advanced Therapies
End-to-end advanced therapy development and manufacturing services
Advanced therapeutics, including cell and gene therapies, have the potential to revolutionize healthcare, and speed is of the essence. Knowing your contract development and manufacturing organization (CDMO) partner has the expertise, capacity, and global supply network is critical to transitioning seamlessly from clinic to commercial with confidence. Patheon pharma services offers the confidence of partnering with an experienced CDMO, combining scale with breadth of services and a support network to meet your critical timelines.
Save time and effort with end-to-end solutions to get your therapy to market faster.
20+ years
More than two decades of cGMP advanced therapeutics manufacturing experience, making us a trusted partner
500+
We have manufactured more than 500 viral vector cGMP clinical and commercial lots
130+
We have a proven track record and have produced more than 130 viral vector products globally
45
Flexible network of 45 drug substance suites worldwide
20+ years
More than two decades of cGMP advanced therapeutics manufacturing experience, making us a trusted partner
500+
We have manufactured more than 500 viral vector cGMP clinical and commercial lots
130+
We have a proven track record and have produced more than 130 viral vector products globally
45
Flexible network of 45 drug substance suites worldwide
Advanced therapy CDMO services, solutions, and capabilities
Streamline your translational research to rapidly identify lead therapeutic drug candidates by leveraging high quality material to generate reliable proof-of-concept data. Due to the complexity of viral vector production, inherent challenges persist with establishing and maintaining product consistency throughout development phases. By including appropriate manufacturing and raw material controls during discovery, lead candidates have a strong potential to quickly and easily translate from discovery through preclinical and cGMP manufacturing.
Patheon Translational Services include custom molecular biology (cloning, plasmid DNA constructs), viral vector packaging (Lentivirus [LV], adeno-associated virus [AAV]), and cell therapy services that use established scalable processes with advanced analytical testing representative of future cGMP workflows. Leverage an experienced team of scientists with over 20 years of cGMP manufacturing and technical experience to accelerate product development and facilitate a smooth transition to the clinic.
Molecular biology services options
- In silico analysis (e.g., codon optimization, construct design)
- Cloning (e.g., de novo synthesis, antibiotics resistance cassette swapping, cut-n-paste fragments)
- Plasmid expansion
Viral vector packaging services options
- Customized LV and AAV packaging using suspension, serum-free, triple plasmid transfection in HEK293F-derived cells
- Affinity-based purification method
- Suitable for in vitro and in vivo applications
Additional services available upon request, including analytical testing.
Experience the benefits of Patheon Translational Services:
- Accelerate timelines and de-risk translating to cGMP manufacturing with minimal bridging studies
- High throughput production capacity using scale-down manufacturing processes
- Qualifiable, best-in-class analytical tests
- Well documented cell line lineage and clonality to enable tech transfer
- Optimized for seamless portability into Patheon cGMP manufacturing platforms including Quick to Clinic™ viral vector services, Quick to Care™ services for advanced therapies, or standard process development and manufacturing
- Experienced scientific and regulatory teams who have successfully taken drugs from process development to market
Translational Services generates materials for research use only. Not for IND-enabling studies or diagnostics purposes.
Helpful resources
Plasmid DNA forms the genetic foundation for many therapeutic strategies, and the growth of cell and gene therapies as well as the rapid emergence of the mRNA vaccine market has created intense pressure on manufacturing of plasmid DNA. We have responded by expanding capacity and service offerings so you can get to market faster.
cGMP quality at all stages of development and commercialization
Starting with cGMP raw materials early on can help reduce timeline and clinical efficacy risk associated with transition of raw materials as well as reduce risk of repeat work due to inconsistent quality. Our phase-appropriate service provides access to full cGMP quality plasmid material regardless of clinical phase of use. Enhanced traceability and/or customized documentation can be added as needed for an additional fee. This unique approach allows for flexibility in defining a solution that works for your organization from both a cost and quality perspective. Learn more about phase-appropriate service and GMP Now™ Plasmid DNA.
Transparency to support regulatory approvals
Visibility into manufacturing processes, data, and batch records is critical in a regulated environment. Patheon pharma services places a high value on collaborative partnerships, so we strive to provide the visibility and support you need for your regulatory filings.
Capacity and flexibility to scale with you
Capacity is at a premium, and flexibility in cGMP facility design can help ensure your unique timeline and needs can be met. Our production scale options range from 30L to 1000L to address a variety of plasmid applications. Expanded capacity and flexibility partnered with a broad range of services from process development and analytical testing to cGMP manufacturing to storage, logistics, and distribution solutions means our plasmid DNA capabilities can flex and scale with your changing needs.
Helpful resources
Cell and gene therapies have been quickly gaining traction with many market approvals anticipated yearly. Speed is of the essence, which is why having a partner who knows what’s expected in regulated environments, has the flexibility to serve your unique needs, and can assist across your entire value chain is so important.
As a full-service cell therapy manufacturer, our capabilities include process development and optimization, analytical assay development and QC testing, as well as cGMP manufacturing for both autologous and allogeneic workflows across a variety of immune and stem cell types. Specific examples include but are not limited to viral and non-viral modified NK and T cells, HSCs, and iPSCs.
As part of Patheon pharma services, we have been active in pharmaceutical manufacturing for more than 20 years and have the expertise and flexibility you need to continue moving at a rapid pace. We know what regulatory authorities are looking for and how to design facilities compatible with commercial therapeutics so you can meet Pre-Approval Inspections requirements and start manufacturing quickly.
Flexibility and speed in cGMP manufacturing
Our expertise across various therapeutic strategies (e.g., different cell types, genetic modification technologies, autologous, allogeneic, etc.) combined with our ability to build a facility according to your specifications, means we have the flexibility to support your unique process. A “just-in-time” strategy for facility buildout means we can complete your space in less than nine months from time of order to facility qualification. Let’s build your solution together.
Services that span from process development to clinical site distribution
We offer not only process and analytical development, cGMP space, and manufacturing expertise, but also customizable apheresis collection kits and associated clinical/manufacturing site storage and logistics. That means our service offering spans from the start of patient material collection all the way to delivering finished clinical material to patient treatment sites.
Cell and gene therapeutic development is advancing quickly from clinical discovery research to pre-clinical and clinical development phases. That’s why we are investing in strategic partnerships that combine our product and CDMO expertise with partner insights to develop processes and products to advance therapeutic workflows and expedite successful commercial and patient outcomes.
Helpful resources
The emergence of mRNA therapeutics including the development of new vaccines and therapies has created a market constraint on access to critical raw materials and technical expertise. We know nucleic acids and pharmaceutical services and have worked to integrate our capabilities across the operational value chain to enable you to move your mRNA therapeutic from development to commercialization.
Supporting your pharmaceutical operations needs for more than 20 years
We have more than 20 years of operational and regulatory experience in complex sterile manufacturing, including quality scrutiny, supply chain, procurement, and technology transfer. We know what it takes to advance your mRNA therapeutic to market and can support you along the way.
Integrated services and broad capability
Our global network of sites with mRNA capabilities includes linearization, process and analytical development, cGMP manufacture for synthesis and liquid nano-particle (LNP), sterile fill and finish, as well as logistics and supply chain networks. We are well-suited to support your complex and unique cGMP mRNA manufacturing needs, with scale options ranging from 1 to 100 g.
Helpful resources
With experience maintaining the integrity of millions of samples in our global network of biorepositories, we are the experts in transporting, storing, and handling specialized biological samples and material, from ambient to cryogenic temperatures. A thorough understanding of the complexities associated with cell and gene therapies and the challenges of bringing them to patients drives the development of our well-defined and carefully managed processes and services.
Global cell and gene therapy clinical supply support
As the leading service provider to the cell and gene therapy community, we are uniquely positioned with the experience, resources, and global expertise to support our customers on their path toward commercialization. This enables customers to seamlessly conduct clinical trials across multiple geographies while providing patients around the world with access to life-changing therapies.
Our cryogenic storage and logistics, combined with proven components and validated procedures, allow us to configure and replicate each site to meet the specific requirements of individual clinical trials with minimal variation, regardless of volume or geographic location. This is supported by a global comprehensive and integrated quality system based on regulatory requirements, industry best practices, and highly trained personnel.
Specific advanced therapy supply chain solutions include:
- GMP biologics management and storage
- Cold chain logistics and distribution
- Clinical site and specialty courier services
- Continuous monitoring for cryogenic shipments
- Comprehensive chain of custody and identification capabilities (inclusive of serialization)
- Secondary packaging and labeling
- Kit production
Our global infrastructure enables customers to seamlessly conduct clinical trials across multiple geographies while providing patients around the world with access to life-changing therapies. Our cryogenic storage and logistics, combined with proven components and validated procedures, allow us to configure and replicate each site to meet the specific requirements of individual clinical trials with minimal variation, regardless of volume or geographic location. This is supported by a global comprehensive and integrated quality system based on regulatory requirements, industry best practices, and highly trained personnel.