Facilities and Capacities

Biomay operates two GMP manufacturing sites in Vienna: the company’s headquarter in Vienna 1220 (Aspern Seestadt), and the mRNA Competence Center in Vienna 1090.

Multi-Purpose Facilities for Processing and Filling

  • Multi-product / multi-purpose facilities
  • Total floor space 6000 sqm / 60,000 sq ft
  • Multiple cleanroom suites for GMP manufacturing

Upstream processing (fermentation):

  • 3 fermentation suites in class D (ISO 8)
  • 4 personalized fermentations suites in class D
  • 1 cell banking suite class C (ISO 7)
  • Bioreactor capacities: 30L, 50L, 150L, 750L (stainless steel)
  • Bioreactor capacities personalized: 4 x 3L (single-use)

Downstream processing (purification):

  • 4 downstream suites in class C (ISO 7)
  • 4 personalized downstream suites in class C
  • Process chromatography equipment in various scales
  • Spacious state-of-the-art quality control labs
  • Extensive R&D lab space (Manufacturing Science & Technology, MSAT) for process and analytical development

Midstream processing (primary recovery):

  • 3 primary recovery / cell lysis suites in class D
  • Centrifuges, high-pressure homogenizers in various scales
  • Alkaline lysis tank capacity 1000 L
  • Refolding tank capacity 2000 & 1000 L

Aseptic filling:

  • 1 aseptic filling suite; class A (ISO 5) in class C
  • Isolator with automated filling / stoppering line
  • Capacity up to 1500 2R vials

Headquarter Facility

Competence in GMP Manufacturing

Biomay’s headquarters building is a greenfield investment that was constructed and set into operation by end of 2021. Since early 2022, the facility is GMP certified and fully operative. Our new building is a state-of-the-art, high-tech and flexible GMP manufacturing facility which is entirely dedicated to Biomay’s CDMO business (4000 sqm total floor space). It is located in “aspern Seestadt”, a newly formed urban district in the east of Vienna. The main focus of Biomay’s Seestadt facility is large-scale manufacturing of DNA plasmids and recombinant proteins.
Official company address: Biomay AG, Ada-Lovelace Str. 2 / Seestadt, A-1220 Vienna, Austria; +43-1-7966296-100, info@biomay.com

mRNA Competence Center

End-to-End Services for mRNA

Biomay continues to operating its first GMP facility – the former headquarters – in downtown Vienna. Those premises have been significantly expanded in 2023 and are now operated as the company’s mRNA Competence Center. On a total floor space of 2000 sqm, GMP clean rooms, quality control and R&D labs are dedicated to mRNA processing. Predominant services there comprise GMP manufacturing of mRNA, including the respective template DNA for in-vitro transcription. Moreover, that site features a suite for aseptic filling of drug product. It contains an automated aseptic filling line with a class A/C isolator. Current fill & finish capacity make up to 1500 sterile-filled vials per batch.

Facts of Biomay's Seestadt Facility

  • State-of -the-art and fully integrated multipurpose biomanufacturing facility
  • Associated laboratories for quality control, assay development and manufacturing science and technology (MSAT)
  • Construction work started in September 2020
  • Start of GMP operations in Q2/2022
  • Bioreactor scales, gross: 750 L , 150 L, 50 L, multiple 5 L
  • Clean room areas: class A (ISO 5), class B (ISO 5), class C (ISO 7), class D (ISO 8)
  • Dedicated area for parallel processing of multiple personalized (patient specific) batches

Scope of services

What we offer

  • Plasmid DNA, mRNA, recombinant proteins (microbial derived)
  • Quality grades: cGMP and High Quality (HQ)
  • Validation
  • Stability studies
  • Regulatory support

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One-Stop-Shop

  • Vector construction and cell banking;
  • Process- and analytical development;
  • Manufacturing drug substance and GMP starting material;
  • Manufacturing drug product / aseptic filling;
  • Quality control predominantly in-house

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Seestadt Aspern in Vienna

Seestadt Aspern can be reached within 30 minutes from the airport, as well as from Vienna city center (underground U2). > Read more about Seestadt Aspern

Seestadt Aspern: Logo

Biomay’s headquarter is located in the attractive and representative surrounding of an exciting, young, and urban region of Vienna.