Wacker Biotech, mRNA Production & Microbial Process Development Laboratory

Wacker Biotech is a contract manufacturer of therapeutic proteins, vaccines and live microbial products. Their Amsterdam GMP manufacturing facility intends to expand its mRNA production capacity and redesign their process development laboratory.

Location: Netherlands
Sector: mRNA Vaccines

About This Project

Project Description

A suite within Wacker Biotech's facility in Amsterdam will be retrofit for the purpose of manufacturing mRNA vaccine products. 
The study developed layouts for ~1500 sq.m of QC and Bio Process Development (BPD) laboratories and cGMP manufacturing suites. Layouts developed a separate support technical area for clean and plant utilities and HVAC equipment. The goal of the project is to create a cGMP mRNA production suite with multiple equipment trains and a new BPD Suite with a pilot scale microbial fermentation train.  

Process Steps

The process included typical mRNA vaccine process unit operations;

  • DNA template production (microbial fermentation).
  • mRNA synthesis including plasmid linearization, in-vitro transcription (IVT).
  • DSP steps including various chromatography and ultrafiltration/ diafiltration (UF/DF) unit operations.
  • Lipid nanoparticle preparation and encapsulation (LNPs). 
  • Bulk formulation and sterile filling.

Design considered all cGMP requirements, including logical adjacencies, material and personnel flows, containment and product protection as well as considerations for solvent handling and solvent waste handing. The design ensured considerations of working within an existing building and minimising the impact on existing facilities.

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