ProcessDevelopment,Optimization andValidation

Synthetic Route SelectionRegulatory Starting Material DefinitionMethod Development StrategypGTI (Potential Genotoxic Impurities) reviewAnalytical Strategy DevelopmentReport Documentation

Chemistry appropriate for your stage of developmentAccess to our highly experienced industry team

Formulation DevelopmentExcipients/Ingredient SelectionDrug Product Analytical Methods DevelopmentAnalytical Strategy DevelopmentReport Documentation

Solutions for all aspects of your drug productdevelopment needsAccess to our highly experienced industry team

Experienced management of these activities ensures thequality of the materials being produced and the reliabilityof the clinical and commercial supply chain as it movesfrom bench-top through scale-up. We have experiencewith small molecule and biotechnology processes.

Chemical DevelopmentThe DSI team of development experts has unparalleledprocess chemistry and bioprocess expertise. We assistearly-stage companies manufacturing early phase clinicalsupplies to setting commercial-scale processes andoperations for late-stage or commercial products. Ourteam has developed chemistry and launched multiplepharmaceutical products. We work on technical transfers,DoE, validation, and manufacturing oversight.

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Benefits

Drug Product DevelopmentOur drug product team has wide experience informulation process development, scale-up, andcommercialization of sterile, oral solid, ophthalmic,topical, and veterinary products.

Services

Benefits

Process Research & DevelopmentDSI is your drug development consulting resource. We arededicated to helping you advance your drug from clinicalcandidate selection through commercial success, and helpyou work with your CMOs identified as the best fit foryour specific project needs. CMOs we recommend areorganized and managed by experienced analytical andprocess development chemists and pharmacists to tacklequestions that

Route evaluation and selection and expert review ofexisting routesNovel routes suggested by process expertsRigorous evaluation of the cost of goodsDevise novel synthetic and fermentation technologiesto achieve your manufacturing goals and build IPDevelop processes that operate robustly and safely atscale, ensuring the security of supplyDevelop robust and appropriate analytical methods tominimize scale-up and quality issuesIdentify, develop and implement cost reductionstrategies for existing API synthesesRapid resolution of scale-up issues to avoid costlydelays in compound supply

can only be answered by experiment. Moreover, drawingon the experience of our project managers and theconsulting expertise at DSI, we’ll make sure the rightexperiments are done and the correct conclusions drawnfrom the results.

Your project will follow a well-defined and effective roadmap, with emphasis on open and consistentcommunication. Our structured approach to projectmanagement delivers efficient and timely monitoring ofscientific progress, coupled with tight tracking of bothproject cost and scope. DSI subject matter experts cansupplement the experience and efforts of your owndevelopment group or fulfill all the roles of a completeprocess and analytical development group many oftoday’s emerging companies require.

ServicesAPI Process Research and Development

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Evaluation of formulation optionsDetermination of goals of drug product formFormulation options suggested by pharmacy expertsExperimental evaluation of strongest optionsSolve formulation problems with a designedexperimental program created by our expertsWork out placebo and comparator issues

Expertise in design and execution of critical processparameter analysis and experimental plans consistentwith Quality by Design conceptsEstablish proven acceptable ranges of operationStatistical experimental design (DoE) and focusedstress tests to improve weaker synthetic steps

Support development of robust analytical methods forAPI, drug product, stability analysis, in-processcontrols, and impurities

Identify and select project-appropriate CMOs toconduct experimentsSelect scientists and teams fit-to-purpose and basedon experience and expertiseAll intellectual property (IP) belongs to the client

Bioprocess Strategy DevelopmentRegulatory Master and Working Cell BankDevelopmentStrain SelectionProtein Fermentation & PurificationAnalytical Strategy DevelopmentAnalytical Testing/ValidationFormulation DevelopmentExcipients/Ingredient SelectionReport Documentation

Solutions for all aspects of your bioprocessdevelopment needsAccess to our highly experienced industry team

Drug Product Research & Development

Quality by Design (QbD)

Method Development

Benefits

Bio & Fermentation DevelopmentThe DSI team of development experts has experience inevery aspect of the industry. In addition to small moleculedrug substance development, DSI has extensiveexperience in biological and cell culture technologies,including cell line engineering and recombinant proteinexpression and biotransformation. Our analyticaldevelopment team has comprehensive methodsdevelopment and validation experience.

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WWW.DSINPHARMATICS.COM s o l u t i o n s @ d s i n p h a r m a t i c s . c o m

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