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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, messenger RNA (mRNA) and recombinant proteins for clinical phases I-III.

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Vienna Competence Center,
Lazarettgasse 19,
1090 Vienna,
Austria
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Biomay is a Good Manufacturing Practice (GMP) contract development and manufacturing organisation (CDMO) for plasmid DNA, messenger RNA (mRNA) and recombinant proteins for 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:

Biomay is a contract development manufacturing organisation (CDMO) with headquarters in Vienna, Austria.
The company's cleanroom and quality assurance facilities feature equipment for processes such as homogenisation, chromatography, aseptic filling and lyophilisation.
Biomay produces recombinant good manufacturing practice (GMP) grade proteins and plasmids for DNA vaccines.
  • 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, mRNA, 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 the 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)

Enzymatic processing of DNA:

  • Linearization of plasmid DNA
  • In-vitro transcription (IVT) of mRNA

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).

New Vienna Biotech Manufacturing Facility

Biomay is pleased to announce that it is building a new production facility, which will expand its production capacities tenfold and its headcount almost double.

12 February 2021

Biomay AG

Vienna Competence Center
Lazarettgasse 19
1090 Vienna
Austria

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