Biomay cGMP Contract Manufacturing of Plasmid DNA and Recombinant Proteins
Biomay is a Good Manufacturing Practice (GMP) contract development and manufacturing organisation (CDMO) for plasmid DNA and recombinant proteins (clinical phases I-III).
Headquartered in Vienna, Austria, Biomay has manufactured recombinant biomolecules with microbial systems (E. coli, yeasts) for more than 20 years.
Biomay has a particular track record in GMP manufacturing of advanced therapeutic medicinal products (ATMP) such as:
- Plasmid DNA vectors for cell and gene therapies
- Starting plasmids for viral vectors such as adeno-associated virus (AAV)
- Non-viral DNA drug substances such as DNA-vaccines
- Personalised, patient-specific DNA plasmids
- Linearised DNA templates for in-vitro messenger ribonucleic acid (mRNA) transcription
- Gene editing materials such as recombinant CRISPR-associated protein 9 (Cas9) nucleases
Scope of GMP contract services
Biomay offers the following GMP contract services:
- Host / vector development
- Current Good Manufacturing Practice (cGMP) cell banking (master and working cell banks)
- Technology transfer and scale-up
- Process development and optimisation
- cGMP manufacturing of active pharmaceutical ingredients (API) / drug substance (plasmid DNA, recombinant proteins)
- cGMP manual aseptic filling (drug product)
- Quality control with well-established / validated assays
- In-house Qualified Person (QP) release
- Validation (assay / process / cleaning)
- Storage and stability testing
- Regulatory support such as Investigational Medicinal Product Dossier (IMPD) / Investigational New Drug (IND) applications
Plasmid DNA manufacturing
Biomay manufactures GMP-grade plasmid DNA (pDNA) for third party clients. As a plasmid CDMO, Biomay addresses clients requiring batch sizes ranging from 100mg to 20g.
Biomay´s plasmid DNA technology features:
- High-yield E. coli hosts
- High-cell density cultivation
- Optimised culture media (no antibiotics or animal compounds)
- Scalable alkaline lysis
- High-performance downstream process (mainly single-use systems)
- Highly homogenous pDNA (more than 90% supercoiled)
Biomay offers these quality levels for plasmid manufacturing:
- Full GMP/cGMP for drug substances and critical start materials
- High-quality for DNA transcription templates and pre-clinical materials
- Research and development (R&D) for research purposes
GMP facility and manufacturing capacities
Biomay`s GMP facility consists of following areas:
- Cleanroom class D (upstream / midstream processing)
- Cleanroom class C (downstream processing)
- Cleanroom class A/B (unidirectional airflow units for aseptic filling)
- Airlocks for personnel and material flow
- State-of-the-art heat ventilation and air conditioning (HVAC)
- Preparation, service and storage areas
- Quality control laboratories
Processing equipment and techniques
The complete processing chain for microbial biopharmaceuticals is established. Biomay caters to:
Upstream
- Rotary shakers
- Bioreactors: 5l / 25l / 45l
- Fed-batch fermentation / high cell density cultivation
Midstream:
- Batch or continuous flow centrifuges
- High-pressure homogenisers
- Alkaline cell lysis
- Protein refolding
Downstream (purification):
- Process chromatographies (pilot-scale, up to ~20g drug substance/batch)
- Chromatographic techniques: capillary electrochromatography (CEC), anion-exchange chromatography (AEC), hydrophobic interaction chromatography (HIC), immobilised metal affinity chromatography (IMAC) and affinity chromatography (AC)
- Filtration techniques such as depth, ultrafiltration (UF) / depth filter (DF)
Filling and finishing (partially with subcontracting partners):
- Aseptic 0.2µm filtration
- Manual aseptic filling / class A
Analytical services and quality control
Analytical testing and in-process controls conforming with United States Pharmacopoeia (USP) / European Pharmacopoeia (PhEur) standards are offered. Assay development, validation and stability testing can be performed. Biomay employs a certified QP for internal drug product release.
Established analytical methods:
- Electrophoresis: Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), Western blot, Agarose gel electrophoresis (AGE)
- High-performance liquid chromatography (HPLC), including reversed-phase (RP), ion-exchange chromatography (IEC), and size-exclusion chromatography (SEC) varieties
- Spectroscopies: ultraviolet (UV), optical density (OD) 600, mass spectrometry (MS), circular dichroism (CD) and dynamic light scattering (DSC)
- Immunochemical: Enzyme-linked immunosorbent assay (ELISA), (product-specific, host cell protein, host cell DNA)
- Microbiological: bioburden, viability, phenotypic identification, plasmid retention, bacteriophages
- Other methods: peptide / restriction mapping, DNA / protein sequencing, amino acid composition, endotoxins, total organic carbon (TOC).
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Vienna Competence Center
Lazarettgasse 19
1090 Vienna
Austria
