Manufacturer of recombinant proteins, GMP raw materials and analytical services for biopharma and cell/gene therapy
ACROBiosystems Group (ACROBiosystems百普赛斯生物科技股份有限公司)
Suzhou (CN) · Newark, DE (US) · Boston, MA (US) · San Jose, CA (US) · San Diego, CA (US) · Frankfurt am Main (DE) · Zug (CH) · Chessington (UK) · Beijing · Shanghai · Tokyo · Seoul · Paris · BaselNew on Amplifa
About ACROBiosystems
ACROBiosystems Group is a biotechnology company founded in 2010 and listed on the Shenzhen Stock Exchange since 2021, focused on recombinant proteins, antibodies, GMP raw materials and analytical services for the biopharma industry. The portfolio comprises more than 5,000 recombinant protein products, cytokines, antibodies, enzymes, Magnetic Beads, ELISA and TR-FRET kits as well as functional cell lines (HEK293, CHO, Jurkat, Raji) with global commercial license support. Production is based on eukaryotic mammalian cell-based expression with chemically defined, serum-free and animal-origin-free media in the upstream process. The centerpiece is a GMP manufacturing facility in Suzhou, China (5.4 acres, USD 90 million investment) with cleanroom, single-use technology, oRABS/isolator filling systems (glass vials 2R–50R, bags, PETG bottles) and lyophilization. This is complemented by an Innovation Lab in Newark (DE, USA) with SPR, SEC-MALS, ELISA and MEA analytics, as well as branches in Frankfurt am Main, Zug and Chessington (UK) for the European market. Customers come from pharma, biotech, vaccine and diagnostics development.
- Site
- Frankfurt am Main
- Processes
- Recombinant Protein Production (mammalian cell-based), GMP-grade Protein Manufacturing (Cytokines, Antibodies, Enzymes, Magnetic Beads), Custom GMP-grade Protein Service, Eukaryotic Protein Expression (MHC complexes, co-expression heterodimers), Formulation/Fill-Finish (glass vials 2R to 50R, bags, PETG bottles, oRABS/isolator), Lyophilization (freeze-drying), Bioreactor Cell Culture (single-use, closed system), SPR (Surface Plasmon Resonance) Analytics
- Materials
- HEK293, CHO, Jurkat, Raji, Chemically defined medium (CDM), serum-free (SF), animal-origin-free (AOF), HEK293 cell line, CHO cell line, Jurkat cell line
- Certificates
- ISO 9001:2015, ISO 13485:2016, ISO/IEC 17025 (SPR service, CNAS accreditation), AAALAC (animal husbandry, antibody generation service), ISO/IEC 17025 (CNAS, SPR), AAALAC (animal husbandry), FDA 21 CFR Part 11 (IT compliance)
- Founded
- 2010
- Industries
- Biopharma, Biotech, Cell and gene therapy (CGT), Vaccines, Diagnostics, Academia
- 01
Cell bank & cell lines (HEK293, CHO, Jurkat, Raji)
- 02
Upstream cell culture (bioreactor, single-use, CDM/SF/AOF)
- 03
Downstream purification (incl. virus clearance)
- 04
Formulation & sterile fill-finish (oRABS/isolator, 2R–50R)
- 05
Lyophilization
- 06
Quality control & release
- 07
Analytics & regulatory support (DMF, IND)
Cell Lines, Media & Expression Systems
HEK293 cell line
Human cell line for recombinant protein and antibody production, traceable back to ECACC.
CHO cell line
Hamster cell line for stable overexpression and protein manufacturing.
Jurkat cell line
Human T cell line for functional cell lines and assay development.
Raji cell line
Human B cell line for functional assays.
Chemically defined medium (CDM, SF, AOF)
Serum-free, animal-origin-free media for low-contamination GMP production.
Sites
Suzhou, China
CNGMP manufacturing facility (5.4 acres, USD 90 million investment)
- Materials
- GMP cytokines, antibodies, enzymes, Magnetic Beads
- Cleanroom (GMP/ISO classified, independent HVAC)
- Single-use bioreactors (closed system)
- Fully automated single-use filling system
- oRABS (B+A) / isolator (C+A)
- Lyophilization
- 24/7 environmental monitoring (PMS, TOC water analysis)
- Validated IT systems (BMS, EMS, SAP, DMS) FDA 21 CFR Part 11
Newark, DE, USA
USOffice and Innovation Lab (R&D and analytics laboratory)
- Materials
- Recombinant proteins, antibodies
- SPR system Biacore 8K (Cytiva)
- Multimode microplate reader SpectraMax i3x (Molecular Devices)
- SEC-MALS analytics
- UNcle protein stability analysis
- Maestro Edge MEA system
Frankfurt am Main, Germany
DEEuropean branch office (Bettinastraße 30)
Zug, Switzerland
CHSwiss branch office (General-Guisan-Strasse 6)
Chessington, UK
GBUK branch office (2 Wetherby Way)
Products & Building Blocks
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Recombinant Protein Production (mammalian cell-based)Biotech/Pharma Manufacturing | – | – | – | – | HEK293, CHO |
| GMP-grade Protein Manufacturing (Cytokines, Antibodies, Enzymes, Magnetic Beads)Biotech/Pharma Manufacturing (GMP) | – | – | – | – | HEK293 |
| Custom GMP-grade Protein ServiceBiotech/Pharma Contract Development | – | – | – | – | – |
| Eukaryotic Protein Expression (MHC complexes, co-expression heterodimers)Biotech/Pharma Manufacturing | – | – | – | – | – |
| Formulation/Fill-Finish (glass vials 2R to 50R, bags, PETG bottles, oRABS/isolator)Biotech/Pharma Fill-Finish | – | – | – | – | – |
| Lyophilization (freeze-drying)Biotech/Pharma Manufacturing | – | – | – | – | – |
| Bioreactor Cell Culture (single-use, closed system)Biotech/Pharma Manufacturing | – | – | – | – | HEK293 |
| SPR (Surface Plasmon Resonance) AnalyticsTesting/Analytics | – | – | – | – | – |
| ELISA Service (method development, validation, kit development)Testing/Analytics | – | – | – | – | – |
| SEC-MALS Characterization (molecular weight, aggregation, purity)Testing/Analytics | – | – | – | – | Recombinant Proteins, Antibodies, Polypeptides |
| UNcle Analytics (Tm, Tagg, particle size via fluorescence/SLS/DLS)Testing/Analytics | – | – | – | – | – |
| Cardiac Organoid MEA Cardiotoxicity ServiceTesting/Analytics | – | – | – | – | human iPSC-derived cardiac organoids |
| Anti-Idiotypic Antibody Development (mono-/polyclonal, single B cell)Biotech/Pharma Contract Development | – | – | – | – | – |
| IHC Antibody Development (Customization)Biotech/Pharma Contract Development | – | – | – | – | – |
| Cell Line Customization (reporter, gene knockout, overexpression)Biotech/Pharma Contract Development | – | – | – | – | HEK293, CHO, Jurkat, Raji |
| Biomarker Immunoassay Development (ELISA/FACS/TR-FRET/IHC)Testing/Analytics | – | – | – | – | – |
| Sterility testing, endotoxin testing, mycoplasma testing, residual testing (GMP QC)Testing/Analytics | – | – | – | – | – |
| Reporter Cell Line Validation ServiceTesting/Analytics | – | – | – | – | – |
7 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| SPR system Biacore 8K | Cytiva Biacore 8K | – | – | – | Delaware, USA |
| Multimode microplate reader SpectraMax i3x | Molecular Devices SpectraMax i3x | – | – | – | – |
| SEC-MALS analytics system | – | – | – | – | – |
| UNcle (protein stability analysis: fluorescence/SLS/DLS) | Unchained Labs UNcle | – | – | – | – |
| Maestro Edge MEA assay system | Maestro Edge | – | – | – | – |
| GMP manufacturing facility (cleanroom, oRABS/isolator filling systems, single-use) | – | – | 5.4 acres, USD 90 million investment | – | Suzhou, China |
| Single-use sterile filling system (fully automated) | – | – | – | – | Suzhou, China |
Additional services
Reference customers
Quality & Certifications
The quality management system is certified to ISO 9001:2015 and ISO 13485:2016; every batch undergoes more than 20 inspection procedures, over 30 tests, 4 audits and 3 releases. SPR service is CNAS-accredited (ISO/IEC 17025); GMP QC includes sterility, endotoxin, mycoplasma and residual testing per USP/EP.
| Evidence | Suzhou, China |
|---|---|
| ISO 9001:2015 | |
| ISO 13485:2016 | |
| ISO/IEC 17025 (CNAS, SPR) | |
| AAALAC (animal husbandry) | |
| FDA 21 CFR Part 11 (IT compliance) |
History
- 2010
Founding of ACROBiosystems
- 2016
First ISO 9001:2015 certification
- 2019
ISO 13485:2016 certification
- 2021
Stock exchange listing on the Shenzhen Stock Exchange; establishment of GMP quality management system
- 2022
Launch of GMP-grade products; CNAS accreditation of the SPR service
- 2024
European logistics center targeting ISO 9001/13485 certification