Our services

Aseptic Fill & Finish Services

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

Utilize our expert Aseptic Fill & Finish services as the final phase in the GMP manufacturing of your biopharmaceutical product.

Aseptic Fill and Finish is the final critical step in the GMP manufacturing of biopharmaceutical products. It is a specialized process, involving highly developed techniques to ensure product sterility for clinical dosing.

Our complete Fill & Finish service chain for Drug Products include formulation, aseptic Fill & Finish, terminal sterilization or aseptic processing, visual inspection, in-house sterility testing, labelling, packaging, and our Qualified Person’s certified release.

Aseptically filled GMP-certified Drug Products can be used for clinical trials or for commercial purposes in gene therapies, immune-oncology, and vaccine applications. Intermediate warehousing of the Drug Products at various temperatures (RT, +4°C, -20°C, and -80°C) is provided on the same EMA (European Medicines Agency) certified site.


Your Fill & Finish Journey

Aseptically filled GMP certified Drug Products can be used for clinical trials or commercial purposes.


Formulation

Fill & Finish

Visual Inspection

Label & Pack

QP Certification

Examples of biologics for Aseptic Fill & Finish

Drug Products can be used e.g. in gene therapies, immuno-oncology, and vaccine applications.

  • AAV, Adenovirus, and other BSL2 class Viral Vectors.
  • Plasmid DNA
  • Recombinant proteins and protein complexes
  • Dilution buffers
  • Placebos

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