Biotechpharma company profile

Romanas Ramanauskas

Business development manager

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October, 2012

Contents

• History

• Company overview

• Services and capabilities – Expression system and process development

– Technology scale-up and GMP manufacturing

– Quality Assurance

– Quality Control

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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

is led by professionals with 20+ years of

R&D experience in biochemistry, biology

and bioprocess engineering

Production

New state-of-the-art GMP facility has experts with 15+

years experience in recombinant protein

manufacturing

Quality

Our quality system ensures process and product compliance

at all stages of development and

commercial manufacturing

Business development

CMO/CRO business model is executed

with support of leading international

pharma marketing and sales company

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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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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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

1400 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

2000 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

Expression system and 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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R&D department 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

Main process equipment capacities

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Bulk 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:

• Bulk DS/DP release testing

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

• Assays / bioassays validation

• 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

Company’s Quality management system is implemented following industry guidance:

• directive 2001/83/EC (code related with medicinal products for human use)

• directive 2004/27/EC (addition to 2001/83/EC)

• directive 2003/94/EC (Principals of GMP for medicinal products for human use and investigational medicinal products)

• EU GMP Guide part I and II

• ICH Q7 guidance

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Strain development

Process development

Scale-up Clinical trial

supply Production

Quality management system

Company’s Quality management system ensures compliance with EU and US cGMP

• Electronic quality management system is in place

• Quality Assurance covers:

– Early stage development (research)

– Late stage development (production)

• Quality Control is a part of Quality Unit and covers full range of quality and in-process control activities

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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:

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Thank you!