Biotechpharma company profile

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October 2013

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 sectors

2007 – Biotechpharma commenced biopharmaceutical R&D activities and started to develop recombinant protein technologies

2011 – new biopharmaceutical R&D center was opened for contract research and development services

2012 – cGMP-compliant biopharmaceutical manufacturing facility was completed

Contract Services Company

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Research and Development

has professionals with 20+ years experience

in biochemistry, biology and bioprocess

engineering

Manufacturing

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

One stop shop from strain development to F&F

Facilities

• R&D centre:

• GLP laboratories for process development

• Administration and meeting areas

• Manufacturing facility :

• GMP Class D, C and B clean-rooms

• QC laboratories, incl. class D, C and B labs

• Utilities area for HVAC, PW, WFI, CS, CA, CW

• Warehouses

• QA and technical offices

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R&D and Manufacturing Services:

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 drug substance and drug product

Process Development Services

• Development of bacterial, yeast 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 supply Manufacturing

Scale-up and GMP Manufacturing Services

• Technology Transfer

• Pilot manufacturing and scale-up

• Manufacturing of microbial and mammalian derived recombinant proteins

• Drug product manufacturing 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 supply Manufacturing

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

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

Strain development

Process development

Scale-up Clinical supply manufacturing

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 supply Manufacturing

Quality Management System

Our Quality management system ensures compliance with cGMP:

• From early stage development to late stage development and production

• Implemented by following EU and ICH 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 supply Manufacturing

Biotechpharma’s electronic quality management system covers:

Areas of Expertise

• Bacterial, yeast and mammalian expression systems

• Cell line development and cell banking

• 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

• Drug substance and drug product cGMP manufacturing

• Project Management

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Track record – selected projects for the last 3 years

• BigPharma - technology transfer, process validation and GMP manufacturing of commercial API (E.Coli)

• EU biotech - design and development of half-life extension platform for 2nd generation fusion proteins (E.Coli, K.lactis)

• BigPharma - Analytical method development for biosimilar recombinant monoclonal antibodies comparability studies

Drug product formulation development for biosimilar monoclonal antibodies. • EU biotech - development and GMP manufacturing of innovative cytokine for

Phase I and II (E.Coli) • US biotech - Human cell line development for neurotoxin bioassay • Asian biotech - development of technology to manufacture blood coagulation

cascade related protease (CHO) • EU biotech - development of technology to manufacture biosimilar recombinant

blood factor (CHO, BHK) • EU biotech - development of technology to manufacture biosimilar monoclonal

antibodies (CHO) drug substance as well as drug product • EU biotech - development of cell line for biosimilar MABs (CHO) • Multinational Co - testing of operational parameters for chromatographic resins • Asian biotech - manufacturing and supply of HCP testing kits based on polyclonal

antibodies

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www.biotechpharma.lt

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