CLEO Life Sciences is a unique hybrid model of Chemistry, Manufacturing, and Controls (CMC) consulting combined with a small-scale R&D prototyping lab for pharmaceutical formulation development. We support clients with nimble prototyping of products and processes, using reduced quantities of API and starting formulation development earlier in the drug development cycle.
CLEO is able to facilitate rapid efficient tech transfers to GMP contract manufacturing sites, troubleshooting, and scale-up. We enable product & process development on highly accelerated timelines and improve management of CMC technical and execution risks.
CLEO has a global network of consultants and relationships with contract manufacturing organizations (CMOs) to integrate or refer the right technical expertise and manufacturing capabilities.
CLEO was incorporated in 2004 in Delaware as a limited liability corporation, and is currently a resident company at Johnson & Johnson Innovation - JLABS @ South San Francisco.
Sean Dalziel, PhD, MBA
CO-FOUNDER & MANAGING DIRECTOR
Sean is a pharmaceutical executive and entrepreneur with expertise in chemistry, manufacturing, and controls (CMC), technical operations, product development, and corporate development. Through Cleo Life Sciences, Sean provides executive consultant roles at multiple biopharmaceutical companies and research services to prototype pharmaceutical drug products and process.
Over 20 years in industry, Sean’s prior employment includes CSIRO in Australia, and in the US – DuPont, Theravance, Onyx Pharmaceuticals, and Tobira Therapeutics in roles of increasing responsibility up to Vice President of Technical Operations and Global Supply Strategy at Onyx and at Tobira. Sean has been a contributor and leader in the CMC development of 4 commercial drugs, including late stage development and NDA support to Oxbryta®, Kyprolis®, and Vibativ®, and early development CMC support to Yupleri TM. Sean has contributed to and/or lead the CMC teams of 25 other clinical staged IND/IMPD drug candidates across dosage forms ranging oral, injectable, and inhaled drug products.
Sean’s academic training includes a PhD in Chemical Engineering from the University of Queensland, MBA from the University of California Berkeley, BSc in Chemistry and Molecular Biology from the University of Sydney, and a BAppSc Hons in Food Technology from the University of Western Sydney.
Drug Substance Consulting
Tech Transfer and CMO management,
Solid Forms Screening, Particle design, and crystallization process engineering
Drug Product Consulting
Formulation development and prototyping,
Scale-down pharmaceutical processes,
Tech transfer, and CMO management for GMP campaigns
CMC leadership, Strategy, CMO management, Executive team representation and BOD level support, Patents, CMC regulatory support,
Corporate Development – support for CMC due diligence, finance raising, investor interactions
Solid oral dosage form prototyping
Roller compaction, dry granulation
Milling (micronization, hammer milling, comilling, screening, homogenization)
Spray drying (amorphous solid dispersions, crystalline dispersions)
Tablets, capsules, granules, powders
Tablet film coatings (cosmetic and functional)
Liquids, suspensions, pediatric product versions, injectable solutions
Solubility, disintegration, dissolution assessments
Physical characterization, density, flowability, friability, hardness testing, microscopy, DSC, TGA, milling assessments
Compaction simulator, controlled release formulations, DOE and design space studies, process development for scale-up
Leading stability studies. in vivo study supplies (tox, efficacy, PK) – suspensions, capsules, tablets
Preparation of sample dosages for analytical validation, and process tech transfer support
Prototype bottle packaging
DOSAGE FORM PROTOTYPING
A P P R O A C H
Focus on rapid, scale-down methods
Prototype drug products at small scales in a manner representative of larger scale GMP manufacturing processes
Apply particle engineering principles and experience for rapid and efficient tech transfer to pharmaceutical CMO production sites
ADVANTAGES of small-scale prototyping:
Initiate dosage form development earlier, requiring much less API
Fast turn around of experiments and product concepts
More rapid and efficient path to clinical supplies in terms of time, cost, and API requirements