Biotechpharma company profile

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October, 2012

History

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2004

2012

2007

2004 – Biotechpharma UAB established as a

proteomic research company in Vilnius, Lithuania

2005 – Company became a member of UK’s

Northway group, investing in healthcare and

biotechnology areas

2007 – Biotechpharma established

biopharmaceutical R&D activities and started to

develop recombinant protein technologies

2011 – new biopharmaceutical R&D center was

established to provide contract research services

2012 – cGMP-compliant biopharmaceutical

production facility was constructed

Biotechpharma is a contract services company

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Research and Development

has professionals with 20+ years experience

in biochemistry, biology and bioprocess

engineering

Production

all projects are executed in a state-of-the-art GMP facility by experts with 15+ years

experience in recombinant protein

manufacturing

Quality

our quality system ensures process and

product compliance at all stages of research,

development and commercial

manufacturing.

Business development

our business model is executed with

support of leading international

companies searching for partners and

customers

Facilities

• R&D centre (1320 sq.m. total area):

• 800 sq. m. of GLP laboratories for process development

• Administration and meeting areas

• Production facility (2080 sq.m. total area):

• 700 sq. m. of class D, C and B clean-rooms including QC

• 580 sq. m. utilities area for HVAC, PW, WFI, CS, CA, CW

• 800 sq. m. of warehouses, QA and technical offices

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Integrated R&D and manufacturing services for all stages of biopharmaceutical development

Strain development

Process development

Scale-up Clinical supply Commercial

manufacturing

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R&D services GMP manufacturing services

1320 sq. m. R&D department houses over 800 sq. m. of GLP laboratories for:

• Strain development

• Upstream process development

• Downstream process development

• Biological assay development

• Quantitative/qualitative protein analysis

• Protein structure research

• Process /Protein characterization

2080 sq. m. EU and US cGMP-compliant recombinant protein and final pharmaceutical product manufacturing facility is designed for production of:

• Mammalian cell line or bacteria derived bulk drug substance up to 200 g per batch

• Liquid drug product in vials and pre-filled syringes for clinical supply up to 20.000 units per batch

• Lyophilized drug product up to 2.000 vials per batch

• Commercial manufacturing drug substance and drug product

Process development services

• Development of bacterial and mammalian expression systems

• Establishing and maintaining microbial cell banks

• Development of microbial and mammalian cell-line upstream processes

• Development of downstream processes

• Analytical methods development and validation

• Formulation development

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Equipment: PCR-analyzers, Bioreactors, Bio-analyzers, Electrophoresis equipment, Conventional and 2D chromatography systems, TFF units, UV-VIS spectrophotometers, ESI and MALDI TOF mass spectrometry systems, HPLC units

Strain development

Process development

Scale-up Clinical trial

supply Production

Technology scale-up and GMP manufacturing services

• Technology Transfer

• Pilot manufacturing and scale-up

• Manufacturing of microbial and mammalian derived recombinant proteins

• Drug product F&F development and clinical supply

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cGMP-compliant recombinant protein and final product manufacturing facility is designed for production of:

• Mammalian cell line or bacteria derived bulk drug substance up to 200 g per batch

• Liquid drug product in vials and pre-filled syringes

• Lyophilized drug product

Strain development

Process development

Scale-up Clinical trial

supply Production

Equipment and capacities

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Drug substance manufacturing:

• Microbial bioreactors: 30 and 300 L volume

• Mammalian bioreactors: 5-50 and 200 L volume

• Chromatography systems: up to 3 L/min flow rate

• Harvesting: 20kG continuous centrifuge

• Ultrafiltration/Diafiltration units: up to 5 sq. m.

Drug product Fill and Finish:

• Liquid in vials: up to 20,000 vials per batch

• Freeze dried in vials: up to 2,000 per batch at 1 ml volume

• Pre-filled syringes: up to 20,000 per batch

Strain development

Process development

Scale-up Clinical trial

supply Production

Quality Control

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QC department performs:

• DS/DP/IPC and release testing

• Assays / bioassays validation

• Real time, accelerated and stressed stability studies according to ICH guidelines

• Process validation support testing

– Process related impurities

– Product related impurities

– Buffers mixing/stability

– Cleaning verification/validation QC unit equipment: HPLC, RT-PCR, Capillary electrophoresis, Absorbance plate reader, UV/Vis

spectrophotometer, Analyzer of sub-visible particles in liquids, Automated cell culture analyzer,

Sterility testing equipment, Climatic chambers, Automated titrators, Immunoassays equipment

Strain development

Process development

Scale-up Clinical trial

supply Production

Quality management system

Our Quality management system ensures compliance with EU and US cGMP:

• From early stage development to late stage development and production

• Implemented by following guidance and directives (directive 2001/83/EC, directive 2004/27/EC , directive 2003/94/EC, EU GMP Guide part I and II, ICH Q7 guidance)

• Supported by comprehensive electronic quality management system

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• Documents management

• Training management

• Change control

• Equipment calibration/maintenance

• Deviation control

• Corrective and preventive action

• Out-of-specification/out-of-trend

• Risk assessment and management

Strain development

Process development

Scale-up Clinical trial

supply Production

Biotechpharma’s electronic quality management system covers:

Areas of expertise

• Cell line development and cell banking

• Bacterial, yeast and mammalian expression systems

• High productivity biosynthesis process

• Efficient protein refolding and downstream processes

• cGMP compliant analytical development and stability testing

• Technological audit and process transfer support

• Stable protein formulation development

• Bulk drug substance and drug product cGMP manufacturing

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www.biotechpharma.lt

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