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.
Facility Seestadt
Personalized
Production
Aseptic Filling
GMP Fermentation
GMP Fermentation
Quality Control
DSP Purification
GMP Manufacturing Area
Manufacturing & Science Technology
GMP Purification
Manufacturing & Science Technology
Quality Control
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.
