Cellculture- Gene to GMP

ExperienceFlexibility

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Experience Flexibility. Cell culture - Gene to GMP.With more than a decade of cell culture development and manufacturing experience and a dedicatedteam of expert scientists, Fujifilm Diosynth Biotechnologies offers a full range of process and analyticaldevelopment services, combined with flexible cGMP manufacturing assets, to support you through thefull life cycle of your product, from preclinical development to commercial manufacture.

Gene to GMPFollowing significant investment in the latest equipment for cellline development, process scale-up and cGMP manufacture,we are able to support your full product life cycle for mAbs and non-mAb proteins. Through our alliance with PiramalHealthcare, we also offer a ‘one-stop-shop’ service for theproduction of antibody drug conjugates (ADCs). This issupplemented with the full range of support and developmentservices that would be expected from an experienced CMOwith a long track record of cGMP manufacture.

Cell line developmentOur in-house team of experts is able to offer efficient cell linedevelopment to meet your pre-clinical and clinical materialrequirements.

Vector construction

Cell line development

• Proprietary CHO cell lines

• Construction, cloning and selection

• High throughput screening and selection methodology including ClonePix™2, shaken multiwell plate system and ambr™ microbioreactor system

• Animal component free

Cell banking

• Cell banks created and stored in a dedicated cell banking unit within our mammalian cGMP facility

• Management of cell bank testing

• High throughput vial filling

Cell culture process development Focusing on yield, product quality and robustness, we offerplatform or customized approaches for rapid development,optimization and scale-up of processes to enable quicktransition to cGMP production.

Platform approach for mAbs

Toolbox of media and feeds for rapid development and optimization

Single use process platform for cell culture, harvest and purification

Micro- and lab-scale bioreactors to demonstrate process scalability

• ambr™ microbioreactor, 2L & 10L

Rapid process development for antibodies and non-antibody proteins

Scale-down modelling, process characterization andvalidation studies for reliable commercial manufacturing

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Protein conjugations

Viral clearance process support

Pre-formulation development

Drug substance and drug product formulation

TECAN™ resin screening

Analytical methodsUsing state-of-the-art analytical instrumentation techniques wewill provide the complete analytical package for your IND, BLAor comparability protocol.

Product release - SE-UPLC, CEX-UPLC, iCE280, CE-SDS,Product Characterization - Micro-Flow Imaging™, NP-UPLCGlycan, ESI-MS, DSC, CD, LC-MS

Process related impurities: DNA, HCP, residual Protein A

Force degradation

Design of stability trials

Impurity characterization

Pilot scaleSingle-use or stainless steel bioreactors available todemonstrate scale up and to produce material for pre-clinicalinvestigations ahead of GMP manufacture.

10L - 25L rocking bioreactors

200L single use bioreactor or 110L SS

Harvest via filtration or centrifugation

Scale-up/scale-down modelling

Purification process development We offer a platform purification development process to allowrapid scale-up for the production of mAbs, and custombespoke processes for non-mAb proteins.

Purification development for antibodies and non-antibody proteins

Protein modifications, including PEGylation

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101 J. Morris Commons Lane, Morrisville NC 27560 Tel: +1 (866) 762 6259

Belasis Avenue, Billingham TS23 1LH, United Kingdom Tel: +44 (0) 1642 363511

Email: enquiries@fujifilmdb.com www.fujifilmdiosynth.com

March 2014©FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

Quality and regulatory supportAs you would expect of a world class CMO, we provide all the necessary quality and regulatory support through anindependent quality unit to ensure your product meetsinternational regulatory requirements. Our regulatoryinspection history includes FDA (CBER and CDER), EMA,MHRA, Health Canada, ANVISA and Korean FDA, andcertification by JMHLW.

Regulatory support for IND/CTA submission, DMF and CMC as required

Design of stability trials and forced degradation studies

Design, testing and validation of cleaning methodologies

QP release

cGMP manufacturingA range of flexible cGMP production options are available atour Billingham UK or Research Triangle Park, NC, USAfacilities:

Clinical and commercial production

Process and cleaning validation

Program ManagementOur distinctive approach to Program Management enables acollaborative and trusting relationship, ensuring that we meetour customers’ strategic, technical and quality goals in a timelyand cost effective manner.

Each program is supported by a dedicated multi-disciplinary team, led by an experienced and focused program manager

Close customer interaction is promoted through regular teleconferences and face-to-face meetings

Programs are milestone structured to ensure timely delivery

Stainless Steel Single-use

1 x 110L 1 x 200L1 x 2000L 2 x 1000L

1 x 2000L (from H2 2014)

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