BioUETIKON - GMP Bioproduction, Bioprocessing, Process Development and Optimisation

BioUETIKON Limited, a member of the Swiss CPH Chemie + Papier Holding AG, provides upstream / downstream development and GMP CMO services to the biopharmaceutical, medical device and related industries. BioUetikon is based in Dublin, Ireland serving international and local clients from a flexible high quality facility approximately 15 minutes from Dublin Airport on the DCU Campus.

Core competence and experience includes:

• Bioprocess development and optimisation
• GMP compliant contract manufacturing production in multi-suite facility
• Mammalian / insect cell culture
• Downstream processing and purification development and bio processing
• QA (Quality Assurance) including in house QP (Qualified Person)
• Contract process research and development
• Ten years' experience of API supply

CGMP CELL CULTURE BIOPRODUCTION SERVICES

BioUETIKON offers contract cGMP cell culture services for the production of biologics for clinical trials or market supply. BioUetikon's cell culture team have expertise in mammalian (suspension / adherent) and insect cell culture systems in batch, fed-batch or perfusion modes in a range of bioreactors. We also have an excellent track record in optimising, scaling up and validating cell culture processes. BioUETIKON s class C (10,000) multi-product cell culture facility has been designed to provide dedicated production suites for each client.

DOWNSTREAM BIOPHARMA PROCESSING

BioUETIKON prides itself on its broad and flexible capabilities for resolving the protein purification needs of clients. We can offer process development and purification method development at scale in dedicated class 10,000 self-contained processing suites. Personnel are experienced in the composite disciplines of downstream processing and chromatography of protein products including protein A.

ANALYTICAL SERVICES - PROTEIN AND PEPTIDE ANALYSIS

BioUETIKON's analytical laboratory specialises in protein and peptide analysis including method development. Services include:

• Total protein content estimation e.g BCA, chemical methods / extinction coefficient
• Immunoanalysis
• Immunoblotting
• ELISA methods
• Protein identity
• Quantitative analysis HPLC (size exclusion, reverse phase, peptide mapping)
• ISO electric point determination
• Analytical method development
• UVA280
• pH and appearance
• SDS-PAGE (R) and SDS-PAGE (NR)
• IEF
• Endotoxin and bioburden
• Mass spec
• HPLC
• DNA
• Cell based bioassay for activity
• TOC
• IEF-Western
• In process assays / testing
• In house microbiologist and environmental monitoring
• Method development / validation

VALIDATION, MICROBIOLOGY AND ENVIRONMENTAL MONITORING

BioUETIKON was awarded its first commercial product licensed in 1995 and has been successful in all IMB (EMEA) audits since 1998. We have our own in house qualified person and a QA department with validation, microbiology and environmental monitoring.

CGMP BIO-PHARMACEUTICAL MANUFACTURING FACILITY

• 1,200m² state-of-the-art manufacturing facility with fully independent ambient and 4°C grade C 10,000 production suites
• Suites designed to accommodate multi-product projects and have multiple air-handling systems
• Unidirectional personnel and material flow
• Separate media prep and support areas
• Cold storage
• Non cGMP development suites also available

UTILITIES

• Purified water to Ph.Eur and USP
• Centralised distributed gas system N2, CO2, O2 air and mixed gas
• Centralised process alarm system, with alarm inputs in all production suites, linked to security system
• Back up generator system available in all production suites
• Plant steam
• Full range of ancillary equipment on site including GMP and waste autoclaves, washers etc.