Driving Client Value for Viral Vector Manufacturing Through a Platform Approach

Andelyn Biosciences is a Cell and Gene Therapy CDMO with 20+ years of experience manufacturing Advanced Therapies from its origins at Nationwide Children’s Hospital.

Driven by our mission of bringing more treatments to more patients, Andelyn offers a platform approach for suspension and adherent manufacturing that provides value based on three key cornerstones:

1. Cost Savings

• High yielding, scalable and high percentage of full capsids drives manufacturing costs down coupled with improved safety profile

• Assurance of program success through process experience and a track record of reproducibility and operational efficiencies

• Reduced upfront investment in Process Development Activities

• No Cell line licensing fees for manufacturing until BLA

• Continuous carrying of cells – no MCB/WCB manufacturing upfront costs

2. Expedited timelines

• Fully integrated CDMO from MCB/WCB generation to plasmid manufacturing, vector production and extensive in-house analytical capabilities

• Well-characterised platform reduces process development and analytical development activities scope and timelines

3. Reduced risk from IND to Commercial

• Ph1 to Commercial occurs in same site with no need for tech transfer

• Platform approach drives seamless transfer from Pre-Clinical to Commercial through process harmonization

• Nimble and scalable capacity to 2,000L

Scale

Maintaining Titer across multiple scales because some of the work they did on the design of experiments and optimisation of their processes have transferred to us and we then scaled that up even further.”

As with any company, supplier relationships are key and here Emmanuelle discusses Cytiva’s close relationship with Polyplus – a leading upstream solutions provider that supplies Cytiva with transfection reagents and plasmids.

“We interact with Polyplus in collaboration, for instance when we use their transfection reagents to generate material or do experiments that help us towards our thought leadership work. We also engage with each other to support shared customers and to generate joint thought leadership content.”

What are some of the main opportunities or obstacles in the gene therapy industry and how is Cytiva leaning into them?

Emmanuelle describes the sheer volume of drugs that are in the clinical and late-stage clinical phase right now.

“We have shown we can make viral vectors and get them approved by the regulatory bodies and balance safety with efficacy,” explains Emmanuelle. “But they are still very expensive. So now we have to manufacture them with better, newer tools using analytics to make this process more efficient and better predict when we are developing a process to reduce the R&D costs that go into the therapy cost, so the therapies go into the clinic faster.

“There are some cases where therapies can be fast-tracked if the indications are incurable and depending on the country. But we need to be working together with the regulatory bodies so they can keep up with our new solutions. We now have all these different tools amongst mRNA, saRNA, viral vectors, cell therapy, gene-modified cell therapy, oligonucleotides etc, that form what we could call a scientific toolbox. But now scientists have to figure out what is the best tool for what problem, to cure specific diseases. This will be a revolution because it will allow us to develop the best drugs or therapies for the specific diseases, optimally and effectively.”

What are the principal ambitions and growth plans at Cytiva in 2023 and beyond?

The ambition at Cytiva is to be the biggest supplier in the biotech industry, specifically within the genomic medicine industry.

With the combined Pall Life Sciences and Cytiva portfolio, Emmanuelle says, “We can really answer the customer needs from the early stage of the process to the final stage of the process for delivering therapeutics, regardless of scale, including process automation and/or single-use products.

“Our goal is to continue building on this prominent position while helping and advancing medicine – it’s our core driver to bring these lifesaving and life-improving therapies to people around the world.”

For more information about Cytiva, visit cytiva.com.

A New Chapter

Emmanuelle is thrilled about the recent integration of Pall Life Sciences and Cytiva.

“We’ve been working on this for years and it’s finally here and I can hardly believe the day has come to pass. But we believe it was the right thing to do and it’s pointing us in the right direction to help our customers and advance genomic medicines.”

Events

Emmanuelle has her fingers crossed that she will be presenting Cytiva’s collaborative work with Virica towards the end of the year in Dublin at the Cell and Gene Therapy Manufacturing & Commercialization Europe conference.

She also invites readers to attend her Cytiva Live 30 webinar on June 13, 2023.