Biomay - GMP-Grade Recombinant Proteins and Plasmid DNA

Biomay is a contract manufacturing organisation (CMO) for GMP-grade recombinant proteins and plasmid DNA. Headquartered in Vienna, Austria, Biomay has manufactured recombinant biomolecules with microbial systems (E. coli, yeasts) for more than 20 years. In addition, Biomay has a product development focus in the field of preventive and therapeutic vaccination against allergic diseases.

GMP contract services

Biomay offers the following GMP contract services:

• Host / vector development
• cGMP cell banking
• Technology transfer and scale-up
• Process development and optimisation
• cGMP manufacturing of API (drug substance)
• cGMP manual aseptic filling (drug product)
• QC with well-established / validated assays
• In-house QP release
• Validation (assay / process / cleaning)
• Storage and stability testing
• Regulatory support (IMPD / IND)

Our expertise, flexibility and excellent price performance ratio are our strengths as a biotech CMO.

GMP facility and manufacturing capacities

Biomay’s GMP facility consists of the following areas:

• Clean room class D (upstream /midstream processing)
• Clean room class C (downstream processing)
• Clean room class A/B (unidirectional airflow units for aseptic filling)
• Air locks for personnel and material flow
• State-of-the-art heating, ventilation and air conditioning (HVAC)
• Preparation, service and storage areas
• Quality-control laboratories

Microbial biopharmaceuticals processing equipment and techniques

The complete processing chain for microbial biopharmaceuticals is established.

• Upstream: rotary shakers, GMP bioreactor 25l (non-GMP 15l), fed-batch fermentation / high cell density cultivation
• Midstream: batch or continuous flow centrifuges, high-pressure homogeniser, alkaline cell lysis, and protein refolding
• Downstream (purification): process chromatography (pilot-scale, up to 10g per batch), chromatographic techniques (CEC, AEC, HIC, IMAC, AC), filtration techniques (depth, UF / DF)
• Filling and finishing: aseptic 0.2µm filtration, manual aseptic filling / class A

Analytical services and quality control

Analytical testing and in-process controls that conform with USP / PhEur standards are offered. Assay development, validation and stability testing can be performed. Biomay employs a certified qualified person (QP) for product release.

Established analytical methods include:

• Electrophoresis: SDS-PAGE,Western blot, AGE
• HPLC (RP-, IEC-, SEC-)
• Spectroscopies: UV, OD600, MS, CD, dynamic light scattering
• Immunochemical: 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, TOC

Plasmid DNA manufacturing

Biomay manufactures GMP-grade plasmid DNA (pDNA) for third-party clients and its own clinical pipeline (DNA vaccines / allergy treatment). As a pDNA CMO, Biomay caters for clients requiring batch sizes of 100mg to 5g.

Biomay has entered a technology transfer collaboration with Boehringer Ingelheim RCV (Vienna), enabling the utilisation of Boehringer Ingelheim’s plasmid manufacturing technology at small scale. The production process established at Biomay is well proven, completely compatible with large-scale, and comprises the following features:

• High-yield E. coli hosts
• High-cell density cultivation
• Synthetic media (no antibiotics, no animal compounds)
• Scalable alkaline lysis
• High-performance downstream process
• Highly homogenous pDNA (up to 98% supercoiled)

Biomay’s collaboration with Boehringer Ingelheim offers a comprehensive contract service solution for milligram to several-gram quantities provided by Biomay, and for gram to kilogram pDNA quantities supplied by Boehringer Ingelheim.

Development of allergy vaccines

As a biotech product company, Biomay’s business focus is the development of vaccines against allergic diseases. Based on recombinant proteins and nucleic acid molecules, Biomay’s proprietary and most promising core technologies are:

• Peptide-carrier-fusion vaccines
• Hypoallergen vaccines
• RNA / DNA vaccines

With the main target of preventive and therapeutic allergy treatment, clinical validation of Biomay’s platform is currently ongoing. Biomay is searching for partners for the co-development of its clinical pipeline.