Biomay

cGMP Contract Manufacturing of Plasmid DNA and Recombinant Proteins

Vienna Competence Center, Lazarettgasse 19
, 1090 Vienna
, Austria

Vienna Competence Center, Lazarettgasse 19
, 1090 Vienna
, Austria



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:

  • 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).
Biomay AG

Vienna Competence Center

Lazarettgasse 19


1090 Vienna


Austria

+43 79 662 96100
 +43 796 629 6111 www.biomay.com