GMP MANUFACTURING

BIOLOGICS AND ATMPs

At our cGMP manufacturing facilities in Germany and Switzerland, Celonic is offering multi-scale commercial manufacturing of biologics, vaccines, and Advanced Therapeutic Medicinal Products (ATMPs).

We offer GMP manufacturing services at different scales ranging from 10 L to 2,000 L. Multiple manufacturing slots – 3 x 2,000 L BR  (expandable to 6 x 2,000 L BR) – are available immediately for commercial manufacture of a wide range of therapeutics, including biologics, EVs, and mRNA.

Our commercial manufacturing facilities are fully equipped to cover a wide range of therapeutic modalities including:

  • Proteins – recombinants, antibodies, bispecifics
  • Extracellular vesicles (EVs), RNA, viral vectors
  • Cell Therapy

Site Heidelberg

With the latest commercial manufacturing expansion our Heidelberg site offers more than 10,600 sqm facility with both clinical and commercial manufacturing capacities, including: 

  • 3 × 2,000 L BR Fed – Batch
  • 3 x 200 L BR Fed – Batch
  • 1 x 1,000 L BR Perfusion

Liquid handling capacity: up to 100,000 L per run

For our multiple production GMP lines we offer capacities of:

  • 10 L single-use
  • 50 L single-use
  • 100 L stainless steel
  • 200 L single-use
  • 1,000 L single-use
  • 2,000 L single use

with corresponding downstream process equipment.

Site Basel

At our Basel site, we operate facilities comprising 500 sqm clean rooms of clean room class C for GMP production, as well as labs for cell line development, process development and quality control.

Lab and Production area: 950 sqm
Liquid handling capacity: up to 2,000 L per run

On our 3 GMP lines, we offer capacities of:

  • 50 L GMP, single use
  • 200 L GMP, single use
  • 250 L GMP, single use
  • 1,000 L GMP, single use

with corresponding downstream process equipment.

 

 

Upcoming world – class commercial facility in Stein, Switzerland

Celonic is also expanding its facilities in Switzerland by establishing a new production site and office space spanning 8,500 sqm in Stein.

In this upcoming clinical and commercial cell and gene therapy world-class facility, Celonic will establish multiple modular independent production suites for ATMPs: cell therapy, EVs, gene therapy, mRNA.

The facility will comprise of around 15 production lines with modular production suites and offices and laboratories for process development, method development, quality control services as well as logistics. 

We are aiming to start operations by Q2 2022.

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