30 years of successfully combining Quality, Performance & Integrity with individual approach to every Client

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Our mission is to provide clients with Top Qualityreliable services assuring that their criticallyimportant parenteral products reach patientsin need.

By accelerating innovation, flexibility and efficiencywe drive productivity and deliver on our missionto enable our clients to make the world healthierand safer.

PYRAMID

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Years of Corporate ExperiencePartnering with Pharmaceutical

& Biotech Companies

30Commercial Approvals

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COMPANY OVERVIEW

Successfully PassedAudits/Inspections

11Hundreds of Clients Ranging from

Big Pharma to Biotech Startups

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One Stop Shop for Parenteral Products: Services Spanning from Preclinical Development to Commercial Manufacturing and Distribution

Broad pipeline of services for every stage of the product lifecycle: from preclinical to commercial scale

Analytical and ProductDevelopment Services on Clinical

and Commercial Scale

Preclinicaland Clinical Aseptic Manufacturing

CommercialAseptic Manufacturing

cGMP Labeling,Storage, and Distribution

Method development, validationand support testing

Pre-Formulation and Formulationdevelopment for large and smallmolecules

Lyophilization cycle development

In process and release studies

Stability studies

Syringe Filling (0.5-3 mL):Batches up to 40,000 per shift

High Speed Vial Filling with 100% Weight Check (2-30 mL): Batches up to 50,000vials per shift

Lyophilization 23,000 -70 000 vials per cycle

Stability Storage and Testing

Controlled Labeling

Controlled Temperature Storageand Distribution

Clinical Trials Materials Management

Batches starting from 500 units

Syringe Filling (0.5-3 mL)

Syringe fill volume: 0.1-3 mL

Vial Filling (2-30 mL) with low line loss

Vial fill volume: 0.4-30 mL

Lyophilization

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Three Building Campus Conveniently Located betweenLos Angeles and San Diego in Costa Mesa, CA

Headquarters and Commercial Manufacturing(35,000 sq. f.)

cGMP Storage and Distribution Center/QA(40,000 sq. f.)

Preclinical/Clinical Manufacturing(7,000 sq. f.)

Controlled Labeling, Warehouse and Distribution

Clinical Trial Materials Management

Quality Assurance Unit

Small Scale Vial Fill/Finish

Capmatic Bambino 1 nozzle vial filler

Cozzoli 6 nozzle vial filler

Stokes PV-24L Lyophilizer 30 sq. f.

Large Scale Vial/Syringe Fill /Finish

IMA High Speed Vial Filler

Telstar Lyophilizer 213 sq. f.

Cozzoli Semi-Automatic Syringe filler

QC/Analytical Lab

Administration

BUILDINGA

BUILDINGB

BUILDINGC

. . . . .John Wayne

LAX

San Diego

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15 min

45 min

75 min

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AIRPORTS

CLIENT FOCUSEDAPPROACH

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Technical Expertise& Know-How

Flexible & DedicatedApproach to Every Client

Multi-YearSuccessful Collaborations

Quality& On Time Delivery

Result Oriented& Knowledgeable Client Teams

Project Management

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APPROACH

QUALITY BASEDOPERATIONS

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Quality Assurance Unit & AuditingProgram that are Organizationally

& Functionally Independent

Extensive Employee TrainingProgram Designed to AssureConsistency & Compliance

Auditing Program that Monitors Compli-ance With All the Applicable Regulations

& Guidelines

Documentation System that Detailsthe Requirements for All Tests & Processes

Documentation & TrackingProcedures that Ensure Traceability

Change & RiskManagement System

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QUALITY

ANALYTICAL SERVICES

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Quality Assurance Unit Reviews 100%of the Raw Data & Final Reports

Complex Method Developmentfor Large & Small Molecules

Including Low Solubility Compounds

Stability Studies for PrototypeFormulations, Clinical Batches

& Marketed Products

Method Validation Compliant with cGMP/ICH

Over 4000 sq.f.of Laboratory Space

Analytical Services CoverDozens of Methods from HPLC/UPLC and LC/MS to LAL & PM

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ANALYTICAL

PRODUCTDEVELOPMENTSERVICES

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Formulation Optimization& Development

Delivery Vehicles:Liposomes, Nanoparticles, etc.

LyophilizationCycle Development

Small Molecules

Proteins & Peptides

Oligonucleotides

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DEVELOPMENT

ASEPTICMANUFACTURING

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Clinical Scale

Pre Filled SyringesLyophilization

Vials

Commercial Scale

Wide Range of Products:Particles, Large & Small Molecules

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MANUFACTURING

cGMPWAREHOUSE AND DISTRIBUTION CENTER

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Controlled Temperature& Humidity Storage Area

Controlled Printing,Labeling & Packaging

Clinical TrialMaterial Management

Large Volume CapacityLoading Docs for Trucks

Ambient / RefrigeratedFrozen / Ultra Low

Constantly MonitoredStability Chambers

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STORAGE& DISTRIBUTION

PYRAMID Laboratories, Inc., 3598 Cadillac AvenueCosta Mesa, CA 92626

info@pyramidlabs.com

714.435.9585

www.pyramidlabs.com

714.435.9800 THANK YOU!