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Oral and Topical Formulations

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Oral and Topical Formulations 01/27 PHARM R&D CENTER OF EXCELLENCE • Specialists in injectable drug formulations and combination drug product development • From solution injectable to complex formulation design (immediate and extended- release) • Drug product R&D for small molecule, peptide, and protein from research to commercialization • Extensive experience in biologics, drug development, device, and delivery technologies • Highly-qualified Ph.D. scientists working in state-of-the-art R&D lab in heart of San Diego 02/27 CONTRACTED DRUG PRODUCT R&D • Leveraging a deep understanding of molecular properties, formulation, device • Integrating delivery system R&D projects into your development program • Optimizing target product profile to enhance value proposition Discovery Support Drug Product Development Integration with device • Lead molecule profiling • Formulation design • Device identification • Clinical candidate evaluation • Drug product development • Formulation compatibility • Biologic half-life extension • Analytical methods • Device product development 03/27 R&D LAB CAPABILITIES Pharmaceutical R&D Laboratory • Formulation, analytical, process, chemistry, device development • Specialists in complex drug product development • Peptide and small molecule chemistry, conjugation (e.g., PEGylation) • Lead candidate selection, optimizing pharmaceutical properties Drug Product Development Strategic Partnership • Strategic product development and hands-on technical support • Participation in CMC teams (analytical, formulation, chemistry, device) • Translation of innovative technologies from research to clinic Partnering to Develop New Delivery Technologies • Extended-release injectable delivery technology • Self-assembling delivery technology • Oral capsule device for targeted delivery 04/27 LEADERS WITH DEEP DOMAIN EXPERIENCE Chris Rhodes, Ph.D. Sharon Lee Rhodes, Ph.D. Dave Litzinger, Ph.D. President & CEO Executive Vice President Scientific Advisor Founded Drug Delivery Sharon is a proven strategic Over 22 years of drug Experts in 2014 after 20 leader with a potent discovery and years in biotech and drug combination of skills in the development experience, delivery companies in technical, corporate, including technical and both technical and academic and non-profit leadership roles. executive leadership roles. arenas. Lawrence D’Souza, Ph.D. Laxma Reddy, Ph.D. Shu Fen Wen, Ph.D. Scientific Director Scientific Director Scientific Advisor Discovery, Chemical and Formulation and Process Drug Product Development, Process Development, Development, Small Manufacturing Formulation Molecules and Biologics Over 30 years of late stage Organic chemist with Protein biophysical chemist product development discovery and early with experience in experience and device development experience in extended-release integration. small molecule, peptide, and drug delivery product protein synthesis. development. 05/27 PHARMA LEADERSHIP EXPERIENCE BASE Our Leaders Have Worked at These Companies Our Leaders Developed These Products 06/27 SUPPORT ACROSS DRUG DEVELOPMENT LEAD MOLECULE SELECTION SOLUTION FORMULATION • Peptides • 5C in a Vial • Small Molecules • Lyophilized • Frozen Solution DEVICE INTEGRATION LIFE-CYCLE • Pre-filled Syringe MANAGEMENT • Cartridge • Reformulation • Pen • Long-Acting System • Auto-Injector • Non-Injectable Delivery (Oral, Nasal, Pulmonary) 07/27 MOLECULE AND DELIVERY EXPERIENCE ~ 1K Da ~ 10K Da ~ 100K Da Small Molecules Peptides Proteins Oligos Antibody • IV, SC • SC • SC • SC • SC • Nasal • Inhalation • Nasal • Oral • Nasal • Ocular • Oral 13/27 COMPONENTS OF TYPICAL LAB PROJECTS Lead Molecule Delivery System Drug Product Development Selection Selection Analytical Analytical Formulation Analytical Development Delivery System Research Development Development Methods Stability Feasibility Development Qualification Assessment Formulation Device Lead Process Selection and Technology Preformulation Molecule PK Screening Development Development Transfer Design Scale Up GMP Mfg. Molecule Design Delivery System Design Drug Product Design Peptide/Protein Variants Aqueous or Non-Aqueous Vehicle Pen/Auto-Injector Conjugates for Half-Life Sustained Release Formulation Pre-Filled Syringe Triggered or Targeted Systems Nasal/Ocular Drops/Spray 08/27 PRODUCT DEVELOPMENT SUPPORT Contracted Fee for Service Proprietary Delivery Technology Developability Assessment SubQ Biologics™ Pharmaceutical Development Modulate solubility & dissolution Solutions and Suspensions Alter subcutaneous absorption Aqueous and Non-aqueous systems Improve PK profile and ISR Scale from 1 ml to 10 liter batch size Stability and Preclinical Supplies Analytical Development Long-Acting Technology HPLC Stability Indicating Methods Proteins Content assay and impurity profiles Peptides Various drug product specific QC tests Oligonucleotides Delivery Systems Antibodies PLGA Microspheres and Implants Nanoparticles and Liposomes Extended-release Suspensions IP License Agreement Nasal and Pulmonary 09/27 EXTENDED-RELEASE INJECTABLE APPROACH Liposome for Drug Delivery Daily Weekly Monthly Quarterly Protective layer DNA against immune destruction Suspension Homing peptide Liposome In Situ Gel-Forming System Drug crystallized Lipid-soluble drug in aqueous fluid in bilayer Lipid bilayer Microsphere Non-Aqueous Solution/ Suspension Implant 10/27 EXTENDED-RELEASE INJECTABLE PROGRAMS Compound Type MW (kDa) Injection Frequency Liposome Salt* Gel Microsphere Suspension Small Molecule <1, several Monthly and longer Peptide 1 Weekly to Monthly Peptide 2 3 to 4 Months Peptide 3, 4 Daily Peptide 4 Weekly to Monthly Peptide 4, 5 Weekly to Monthly Insulin 6 Daily to Weekly Oligonucleotide 8 Daily to Weekly Oligonucleotide 10 Daily to Weekly triple combination Protein 15 Weekly Protein 50 Weekly Antibody 150 Weekly to Monthly *Note: Biologics salt forms are based on proprietary SubQ BiologicsTM technology 11/27 FORM SELECTION & PARTICLE SUSPENSION Salt or Co-crystal Dry Ball mill Micro-particle Suspension Form Or Wet Bead mill Selection Drug Substance: Insoluble Crystal Form Free base or acid <0.01 mg/ml at 37C PBS Low rate of saturation solubility Nano-particle Suspension Horizontal oscillatory ball mill for small scale grinding Tube Roller for low energy grinding Vertical planetary ball mill for high energy grinding 12/27 ORAL AND TOPICAL FORMULATIONS Capsule Capabilities at Controlled Release Oral Formulations DDE Labs Through KYDES Partnership Hand-filled Capsule batches Tablet Processes • Powder blends • Direct compression Oral Controlled Release • Microparticle-filled • Dry granulation • Instant release • Microsphere-filled • Wet granulation • Sustained release • Nanoparticle formulations • Enteric coating • Enteric or delayed release • Oil-based suspensions • Bi-layer and mini tablets • Permeation enhancing for Topical peptides Capsules • Transdermal cream • Powder blends • Topical Spray • Microparticle-filled • Microsphere-filled 14/27 NASAL & INHALATION EXPERIENCE Olfactory Non-invasive delivery for small molecule, peptide, protein epithelium • Painless, no needles or injections • Easy administration by patient or caregiver Respiratory region Formulation and analytical development Nasopharynx • Dosage forms: solution, suspension, and dry powder Carina Oropharynx Main bronchus • Chemical and physical stability Trachea Drug product device assessment Bronchi • Dose delivery/content uniformity Alveoli • Particle/droplet size distribution Device • Spray pattern Spray pattern Plume geometry • Plume geometry Formulation Analytical • Leachable and extractable Drug Product 15/27 STATE-OF-THE-ART DRUG PRODUCT LAB 16/27 DDE LABS EQUIPMENT & CAPABILITIES Analytical Development Manufacturing Suite • 17 HPLC (diode array UV Vis, fluorescence, ELSD, RID) • 3 Laminar flow hoods (ISO 5 certified) • UV/Vis & fluorescence plate readers and nanodrop • Vestibule for gowning • Particle size analyzer (laser diffraction, 1µM – 500 µM) • Material handling: depyrogenation oven, autoclave, • Dynamic light scattering / zeta potential (1 nm – 10 µM) chemical fume hood • Stability Chambers certified and monitored (ICH 25ºC/60RH, 40ºC/75RH, 2-8ºC, -20ºC, -80ºC) Bioanalytical Development • Osmometer and Viscometer for characterization • MSD ELISA for bioanalysis • Scanning electron micrograph, visual microscopy • Gel electrophoresis imager for imaging protein gels Formulation and Process Development Chemistry and Chemical Development • Microfluidizer, homogenizer, emulsifiers • Organic synthesis reactors • 37C incubators for In vitro release testing for extended- Rotary evaporator release injectables (water bath and shake-flask) • • Jacketed reaction vessels • Instron Injection force measurement • Manifold lyophilizer • Nano assembler for nanoparticle & liposome • FPLCs for protein purification • Shelf–stoppering lyophilizer for cycle development • Preparatory HPLC • Ball mill, tube roller, planetary ball mill for grinding • Salt, co-crystal, and prodrug selection • Capsule hand-fill for powder and liquid formulations • 2 laminar flow hoods for development work 17/27 MANUFACTURING AND PROCESS SUITE Test Article Preparation – Research to Toxicity Studies Restricted Access – Training Required Suite meets ISO Class 7 Laminar Flow Hoods • ISO Class 5 annual certification Quality System Guidelines • Sterile Technique, Cleaning Documentation System • Process Batch Records 18/27 PROCESS SUITE EXPERIENCE Manufactured over 200 batches in the past 5 years Batch size 1 mL to 2 liters (Capability to go to 20 liter batches)
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