Advanced therapy services

Get your advanced therapy to market faster

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

 

Performance and expertise
We have more than 20 years of experience with current good manufacturing practice (cGMP) regulations for advanced therapeutics manufacturing and know how to deliver for you.

Scale and global capacity
Flexible network of 45 viral vector drug substance suites worldwide with more than 650,000 square feet of cell and gene therapy facilities capacity ensures we can address increasingly complex customer needs.

Breadth of services
With integrated clinical and commercial cGMP manufacturing and supply chain solutions across advanced therapy modalities including mRNA and cell and gene therapies, our broad service offering and extensive network can help you efficiently serve patients worldwide.


Advanced therapy 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.

 

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 plasmid DNA cGMP manufacturing and QC analytical capabilities ensure you get the quality material you need at all stages of development and commercialization, with scale options ranging from 1 mg to 1 kg for plasmid yield.

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 expanded capacity and flexibility partnered with a broad range of services from process development to cGMP manufacturing to storage, logistics, and distribution solutions means our plasmid DNA manufacturing capabilities can flex and scale with your changing needs.

Helpful resources 

Patheon Viral Vector services is your end-to-end viral vector CDMO partner from process and analytical development to clinical and commercial supply of viral vectors for your cell or gene therapy or vaccine. Quality is at the core of everything we do. We strive to exceed our clients’ expectations on every project while ensuring regulatory compliance and the highest product quality possible. What’s more, we’ll work as an extension of your team, operating with transparency and flexibility to keep you involved, engaged, and well-informed at every stage.

Viral vector types and platforms

We have vast knowledge developing processes and producing cGMP viral vectors (including AAV, Adenovirus, Lentivirus, HSV, and Retrovirus) with many different manufacturing platforms. Our platform suspension and adherent processes can be optimized for your product, indication, and route of delivery. We have extensive experience transferring in client processes at a variety of scales for further optimization or to proceed quickly to cGMP manufacturing.

Viral vector process development, characterization, and validation

As your viral vector CDMO partner, we have the experience, expertise, and capabilities to guide your program from development, into clinical trials and through commercialization. Our Viral Vector Services team has produced more than 130 viral vector products to support bringing therapies to market.

Patheon Quick to Clinic viral vector

De-risk your regulatory pathway and accelerate development timelines with a truly all-inclusive platform process that equips your program for long-term commercial success.

With the Quick to Clinic™ viral vector platform, you can get to released drug product for IND more than six months faster than standard process development. Set the foundation for commercial success by utilizing our standardized platform process for 200 L suspension-based AAV and LV vector manufacture that’s inclusive of all raw materials, analytical testing, and commercial-use licenses. Projected project timelines include all plasmid manufacturing and optimization time, with phase-appropriate regulatory support provided throughout the product lifecycle.

All you need to provide are details around your gene of interest and any known product specifications and let Viral vector services do the rest. Key benefits of Patheon™ Quick to Clinic™ viral vector include:

  • Reaching milestones faster
  • Reducing supply chain and regulatory risk
  • Building for commercial success

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.

Helpful resources