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