Our services

Viral Vector Services

Always close, we are with you all the way on your Viral Vector Manufacturing journey. Together, making advanced biologics, and tomorrow’s life-transforming therapies.

This is affinity in the making.

Always close, we are with you all the way on your Viral Vector Manufacturing journey // 3PBIOVIAN / Affinity in the making.

Rely on our comprehensive viral vector process development and GMP production of AAV and adenovirus vectors to accelerate your projects seamlessly.

Our process development services support the Quality by Design (QbD) approach from the earliest stage, enabling a smooth transition to GMP production.

  • Research Cell Bank
  • Master Cell Bank and Working Cell Bank
  • Master Viral Seed Stock and Working Seed Stock
  • 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
  • Ultracentrifugation-based Downstream Processes
  • Chromatography-based Downstream Processes
  • Comprehensive purification solutions – chromatography, membrane processes, Tangential Flow Filtration processes (TFF)
  • Formulation and final Drug Product manufacturing
  • Automated aseptic filling line for live viral vectors
  • Typical batch sizes 200 – 1000 vials
  • Product-specific assays
  • Impurity analysis
  • Cell-based assays
  • Microbiological QC and safety assays (sterility, bioburden, endotoxin etc.)
  • QP certification and full GMP documentation
Always close, we are with you all the way on your Plasmid DNA Production journey // 3PBIOVIAN / Affinity in the making.

Viral Vector Quality Control Services

Biovian offers comprehensive access to quality control analytics for both adenovirus and AAV vector GMP batches, ensuring compliance with regulatory standards for human use. Our services include compendial assays, sample-specific validation, and assistance in developing and validating product-specific analytical methods.

Optimized Viral Vector assurance including QC tests for:

  • Viral vector harvest
  • Control cells
  • Plasmids
  • AAV vector Drug Substances and Drug Products
  • Adenovirus vector Drug Substances and Drug Products

Always close, we are with you all the way on your Aseptic Fill & Finish Services journey // 3PBIOVIAN / Affinity in the making.

Viral Vector Fill and Finish

We provide fill and finish services for AAV and adenovirus-based products. For AAV vectors, fill and finish are conducted in a dedicated aseptic suite (grade A/B, EU GMP) using an automated line validated for 2R and 10R vials, handling up to 1000 vials per batch. Adenovirus vectors are processed in dedicated BSL-2 suites with an automated line also validated for 2R and 10R vials, up to 1000 vials per session. Disposable components are used, and in-house release testing includes sterility testing and 100% visual inspection to ensure product safety.

We offer EMA-certified warehousing solutions for pharmaceuticals at controlled temperatures (RT, +4°C, -20°C, and -80°C) on-site. Once approved by our Qualified Persons, finished vials can either remain in our intermediate GMP storage or be promptly dispatched to clinics.

GMP documentation package:

  • TSE/BSE certificate
  • Certificate of analysis
  • Batch certificate and certificate of GMP compliance
  • GMP production summary report

CMC documentation

  • IND/IMPD CMC documentation support upon request

Stability studies

At 3PBIOVIAN, stability testing services for both AAV and adenovirus vector Drug Substances and Drug Products adhere to ICH guidelines. We conduct comprehensive studies encompassing study planning, analytical QC testing, and reporting, utilizing controlled cabinets to ensure the stability of these products.

With you all the way…

together, making advanced biologics, and tomorrow’s life-transforming therapies.

We deliver unparalleled end-to-end development and manufacturing services for all protein expression systems and viral vectors, both for Drug Substances and Drug Products, from pre-clinical to clinical development and commercial phases.

We support our customers wherever they are on their journey, from early-stage development to commercialization. We are passionate, precise, and always close, together, making advanced biologics and tomorrow’s life-transforming therapies.


Pre-Clinical

Phase I

Phase II

Phase III

Commercial