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@PharmaReview Complete biopharma testing services Eurofins BioPharma Product Testing offers complete CMC testing services for the bio/ pharmaceutical industry, including all starting materials, process intermediates, drug substance, drug product and manufacturing support, as well as broad technical expertise in biochemistry, molecular and cell biology, virology, chemistry and microbiology. What are the main outsourced services that your company provides? Our breadth of services includes: Method establishment, including method development, feasibility, optimisation, cGMP qualification and validation, as well as verification of compendial methods Comprehensive stability and release programs for clinical and marketed products Complete biochemical and chemical characterisation and microbial identification Raw material and excipient testing (USP/NF, EP, JP) Production and non-production cell banking including full characterisation Lot release/unprocessed bulk testing Process/facilities validation, including viral clearance, residual impurities testing, extractables and leachables, water testing, environmental monitoring, disinfectant efficacy and on-site sample collection Consulting/protocol writing GMP manufacturing. What differentiates your company from the competition? With a global capacity of more than 92,000m 2 and 28 facilities throughout North America, Europe and Asia Pacific, our network of GMP laboratories operates under the same strict quality procedures and harmonised LIMS to deliver a seamless service experience across all locations. We continue to expand our facilities, enhance our capabilities and service models and continually invest in information technology to support our steadfast commitment to data quality and data integrity. From the development of our secure, online data access portal, LabAccess.com in2007, to our recent efforts to develop and deploy our global laboratory management system (LIMS) and electronic laboratory notebook (ELN) platforms, we continually develop solutions that further enhance data quality, data integrity, and data accessibility for our clients. We also continue to aggressively make investments to enhance and expand our market-leading biologics capabilities across our global network of Eurofins BioPharma Product Testing laboratories, as well as continuing to drive geographic expansion. All of this is focused on serving our clients with the world’s largest and most comprehensive group of harmonised GMP laboratories. What value-added services does your company provide? We offer clients the flexibility to manage testing programmes more efficiently through the choice of three unique service models, including our award-winning Professional Scientific Services (PSS), Full Time Equivalent (FTE) or traditional fee-for-service. Clients can choose the best, most cost-effective service solution to meet project goals. What are the main drivers affecting the supply and demand for outsourcing services across the pharmaceutical industry? The two primary drivers affecting demand for bio/pharmaceutical testing services include a steady increase in the overall percentage of the total global R&D spend, currently estimated at approximately €117bn, outsourced by big biopharma companies, and a robust funding market for the small or virtual companies. Eurofins has aggressively invested in facilities, equipment and personnel to meet both current and future client needs, and continues to do so. What are the main challenges facing both companies who want to outsource manufacturing or services and those providing these services? It has been, and most likely always will be, communication. Both parties must invest the time necessary to fully communicate all technical requirements and service expectations. To facilitate effective communication, we have doubled the size of our project management staff over the past two years and implemented more formalised project management practices. We are expanding the availability of LabAccess, our innovative online data access tool, so clients have immediate 24/7 access to their certificate of analysis, raw data, and project status. COMPANY DETAILS NAME: Eurofins BioPharma Product Testing ADDRESS: Avenue Herrmann Debroux 48, BE-1160 Bruxelles, BELGIUM TELEPHONE: +32 2 766 16 20 EMAIL: pharma@eurofins.com WEB: www.Eurofins.com/Biopharma GUIDE TO... | OUTSOURCING

Transcript of Complete biopharma testing services · Complete biopharma testing services ... EMAIL:...

@PharmaReview

Complete biopharma testing servicesEurofins BioPharma Product Testing offers complete CMC testing services for the bio/pharmaceutical industry, including all starting materials, process intermediates, drug substance, drug product and manufacturing support, as well as broad technical expertise in biochemistry, molecular and cell biology, virology, chemistry and microbiology.

What are the main outsourced services that your company provides?Our breadth of services includes:

■ Method establishment, including method development, feasibility, optimisation, cGMP qualification and validation, as well as verification of compendial methods

■ Comprehensive stability and release programs for clinical and marketed products

■ Complete biochemical and chemical characterisation and microbial identification

■ Raw material and excipient testing (USP/NF, EP, JP)

■ Production and non-production cell banking including full characterisation

■ Lot release/unprocessed bulk testing ■ Process/facilities validation, including

viral clearance, residual impurities testing, extractables and leachables, water testing, environmental monitoring, disinfectant efficacy and on-site sample collection

■ Consulting/protocol writing ■ GMP manufacturing.

What differentiates your company from the competition?With a global capacity of more than 92,000m2 and 28 facilities throughout North America, Europe and Asia Pacific, our network of GMP laboratories operates under the same strict quality procedures and harmonised LIMS to deliver a seamless service experience across all locations.

We continue to expand our facilities, enhance our capabilities and service models and continually invest in information technology to support our steadfast commitment to data quality and data integrity.

From the development of our secure, online data access portal, LabAccess.com in 2007, to our recent efforts to develop and deploy our global laboratory management system (LIMS) and electronic laboratory notebook (ELN) platforms, we continually develop solutions that further enhance data quality, data integrity, and data accessibility for our clients.

We also continue to aggressively make investments to enhance and expand our market-leading biologics capabilities across our global network of Eurofins BioPharma Product Testing laboratories, as well as continuing to drive geographic expansion. All of this is focused on serving our clients with the world’s largest and most comprehensive group of harmonised GMP laboratories.

What value-added services does your company provide?We offer clients the flexibility to manage testing programmes more efficiently through the choice of three unique service models, including our award-winning Professional Scientific Services (PSS), Full Time Equivalent (FTE) or traditional fee-for-service. Clients can choose the best, most cost-effective service solution to meet project goals.

What are the main drivers affecting the supply and demand for outsourcing services across the pharmaceutical industry?The two primary drivers affecting demand for bio/pharmaceutical testing services include a steady increase in the overall percentage of the total global R&D spend, currently estimated at approximately €117bn, outsourced by big biopharma companies, and a robust funding market for the small or virtual companies. Eurofins has

aggressively invested in facilities, equipment and personnel to meet both current and future client needs, and continues to do so.

What are the main challenges facing both companies who want to outsource manufacturing or services and those providing these services?It has been, and most likely always will be, communication. Both parties must invest the time necessary to fully communicate all technical requirements and service expectations. To facilitate effective communication, we have doubled the size of our project management staff over the past two years and implemented more formalised project management practices. We are expanding the availability of LabAccess, our innovative online data access tool, so clients have immediate 24/7 access to their certificate of analysis, raw data, and project status.

COMPANY DETAILSNAME: Eurofins BioPharma Product TestingADDRESS: Avenue Herrmann Debroux 48,BE-1160 Bruxelles, BELGIUMTELEPHONE: +32 2 766 16 20 EMAIL: [email protected]: www.Eurofins.com/Biopharma

GUIDE TO. . . | OUTSOURCING

From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.

As we have grown to become the world’s largest network of GMP product testing labs, we continue to uphold our founding promise of personal service and impeccable quality.

When the world awaits your product, choose the lab that provides complete capabilities and rigorous quality systems you can trust.

www.eurofins.com/biopharma

BioPharmaProduct Testing

Method Development & Validation • Release Testing • Stability Testing & Storage

Cell Banking Services • Virology Services • Facility & Process Validation

Chemistry • Biochemistry • Molecular & Cell Biology • Microbiology

Raw Materials Testing • Primary & Secondary Package Testing

Comprehensive GMP Testing Services

Australia

Belgium

Canada

Denmark

France

Germany

India

Ireland

Italy

Netherlands

New Zealand

Spain

Sweden

Switzerland

UK

US

Global Facilities

Fee For Service (FFS)

Full-Time-Equivalent (FTE)

Professional ScientificServices® (PSS)

Flexible Service Models

Largest scope of global services.

Sharpest focus on data integrity.