Siirry sisältöön

Viral Vector GMP Production

Biovian has established itself as an experienced and knowledgeable GMP producer of Viral Vectors for gene therapy applications, immuno-oncology and vaccines. Since 2005 we have provided Viral Vector CDMO services to clients in the EU and in the USA; these services include batch manufacturing of several adenoviral vector products. Biovian holds an EMA license for manufacturing of Viral Vector products for clinical trials as well as for commercial use. We offer GMP-grade production of AAV and adenovirus and have the readiness to produce other biosafety level 2 (BSL2) class viruses.

Viral Vector CDMO Excellence with in-house Plasmid Production

Biovian is removing bottlenecks in gene therapy production with true One-Stop-Shop service. As regards Viral Vector production, the services span from in-house GMP plasmid DNA manufacture to Qualified Person-approved release of the final labelled Drug Product.

The strength of Biovian lies in their expertise in adenovirus, their flexibility for manufacturing slots and in competitive pricing. I find people at Biovian pleasant and trustworthy. For us one of the reasons for choosing Biovian was their expertise in Adenovirus and I would gladly recommend Biovian to someone looking for an adenovirus CDMO player.
Vice President of CMC

Gene Therapy CDMO Facilities

The Viral Vector production facility of Biovian allows for flexible contract development and production scenarios. The state-of-the-art BSL2 production facility is equipped with e.g. a 200 liter, single-use bioreactor. This enables efficient manufacturing of Viral Vectors on a large scale for advanced clinical trials and for the support of commercial strategies.

Track Record in Viral Vector Development and Manufacturing

  • Biovian has been developing Viral Vector processes since 2005
  • Over 40 clinical GMP batches have been manufactured (including batches for clinical phases up to Phase III as well as commercial validation batches)
  • Longest-lasting customer relationship >10 years and still active
One of the reasons for choosing Biovian as a partner was their expertise in oncolytic Adenovirus. Biovian has a holistic view on future scenarios of the program. Because of their experience, they can guide their clients through all the steps of the project. I appreciate the fact that Biovian keeps to the deadlines. Their project management is very good. The regulatory documentation of Biovian is also excellent.
Regulatory CMC Manager

One-Stop-Shop CDMO Services in Viral Vector Production

Cell Banks and Virus Seed Stocks

  • Research Cell Bank
  • Master Cell Bank and Working Cell Bank
  • Master Viral Seed Stock and Working Seed Stock

Upstream Processes

  • Suspension Cell Culture in single-use bioreactors – up to 200 L
  • Adherent Cell Culture in multilayer flasks, packed-bed bioreactor and single-use bioreactors on microcarriers

Downstream Processes

  • Ultracentrifugation-based Downstream Processes
  • Chromatography-based Downstream Processes
  • Comprehensive purification solutions – chromatography, membrane processes, Tangential Flow Filtration processes (TFF)

Aseptic Fill and Finish

  • Formulation and final Drug Product manufacture
  • Automated Aseptic Filling line for live Viral Vectors – Filling in vials
  • Typical batch sizes 200 – 1000 vials

Quality Assurance and Quality Control

  • Product specific assays
  • Impurity analysis
  • Cell based assays
  • Microbiological QC and safety assays (sterility, bioburden, endotoxin etc.)
  • QP Certification and full GMP documentation

Viral Vector Process Development Services

Biovian provides comprehensive Viral Vector process development services that are fully integrated with process analytics. Our process development services support the Quality-By-Design (QBD) approach from the earliest possible stage in order to enable a straightforward transition to GMP production.

  • Upstream Process development
  • Downstream Process development
  • Analytical development
  • Development and setting up of in-process control
  • Formulation development
The building of Viral Vector processes from almost any starting point is the expertise of Biovian. Our Process Development team can start the Viral Vector project from a single vial of the virus or from a small volume of plasmids.
Pirjo MerilahtiProcess Development Manager

Read a blog about Viral Vector Process Development

Viral Vector Process Development - Activity Diagram
Viral Vector Process Development – Flow Chart
Download a Viral Vector flyer
Biovian in Biopharma dealmakers June edition
Next step

GMP-Grade Plasmid DNA Production

Biovian manufactures plasmid DNA for a variety of client projects.

Contact Us

Antti Nieminen
Director, Business Development and Projects
Magnus Gustafsson_Biovian
Magnus Gustafsson
Head, Global Business Development
Eero Mustalahti
Manager, Sales and Business Development