Biomay Contract Manufacturing of Plasmid DNA and Recombinant Proteins
Biomay is a contract development and manufacturing organisation (CDMO) providing plasmid DNA (pDNA) and recombinant proteins for Phase I-III clinical trials.
Headquartered in Vienna, Austria, Biomay has more than 20 years‘ experience producing good manufacturing practice (GMP) recombinant biomolecules using microbial systems such as E. Coli and yeast.
Biomay‘s modern facilities feature a 25l bioreactor and equipment for high cell density cultivation, homogenisation, chromatography, filtration, aseptic filling and lyophilisation.
GMP contract manufacturing services
Biomay manufactures recombinant GMP-grade proteins and plasmids for DNA vaccines that are used as active pharmaceutical ingredients (API).
The company specialises in advanced therapeutic medicinal products (ATMP), including plasmid DNA vectors for cell and gene therapies, plasmids for viral vectors such as the adeno-associated virus (AAV), non-viral DNA drug substances and customised DNA plasmids.
Current good manufacturing practice (cGMP) cell banking, technology transfer and scale-up, linearised DNA templates for in-vitro messenger ribonucleic acid (mRNA) transcription and gene editing materials such as recombinant clustered regularly interspaced short palindromic repeats (CRISPR) and CRISPR-associated protein 9 (Cas9) nucleases are also available.
Biomay follows stringent quality control guidelines with validated assays to ensure a repeatable and reliable process. Manufacturing procedures are conducted in-house by highly qualified persons (QP).
Biomay cultivates pDNA in a high-performance downstream process, with a focus on single-use systems. The process utilises high-yield E.coli hosts in batch sizes ranging from 100mg to 20g to meet client requirements. The bacteria are grown in an optimised culture media without using antibiotics or animal compounds, and they are highly homogenous (more than 90% supercoiled).
The company offers its plasmids in three quality levels: Full-GMP Quality for drug substances and critical start media; High-Quality for DNA transcription templates and pre-clinical material; and R&D Quality for research purposes.
Processing equipment and techniques
Biomay’s manufacturing services are available throughout the processing chain for microbial biopharmaceuticals, including:
- Upstream – rotary shakers; 5l, 25l and 45l bioreactors; and fed-batch fermentation units for high cell density cultivation
- Midstream – batch or continuous flow centrifuges, high-pressure homogenisers, alkaline cell lysis and protein refolding
- Downstream – process chromatographies from pilot-scale to a 20g batch, with techniques such as capillary electrochromatography (CEC), anion-exchange chromatography (AEC), hydrophobic interaction chromatography (HIC), immobilised metal affinity chromatography (IMAC) and affinity chromatography (AC)
- Filling and Finishing (partially with subcontracting partners) – aseptic 0.2µm filtration and manual aseptic filling class A
Analytical services and quality control
Biomay’s analytical testing and in-process control services meet United States Pharmacopoeia (USP) and the European Pharmacopoeia (PhEur) standards.
Assay development, validation and stability testing are available, and Biomay employs a certified QP for internal drug product release.
The company’s analytical methods include:
- Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), Western blot and Agarose gel electrophoresis (AGE)
- Reversed-phase (RP) high-performance liquid chromatography (GPLC), ion-exchange chromatography (IEC) HPLC, and size-exclusion chromatography (SEC) HPLC
- Ultraviolet spectroscopy, optical density (OD) 600, mass spectrometry (MS), circular dichroism, and dynamic light scattering (DLS)
- Enzyme-linked immunosorbent assay (ELISA) processing for product-specific, host cell proteins and DNA
- Bioburden, viability studies, phenotypic identification, plasmid retention, bacteriophages
- Peptide and restriction mapping, DNA and protein sequencing, amino acid composition, endotoxins, total organic carbon (TOC) assessment
GMP Facility and manufacturing capacities
Biomay has a range of GMP facilities, including quality control laboratories, Class D cleanrooms for upstream and midstream processing, Class C cleanrooms for downstream processing, and Class A.B cleanrooms with unidirectional airflow units for aseptic filling.
The facilities have state-of-the-art heat ventilation and air-conditioning (HVAC), airlocks for personnel and material flow, as well as preparation and storage areas.