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30
years of successfully combining Quality,
Performance & Integrity with individual
approach to every Client
02
Our mission is to provide clients with Top Quality
reliable services assuring that their critically
important parenteral products reach patients
in need.
By accelerating innovation, flexibility and efficiency
we drive productivity and deliver on our mission
to enable our clients to make the world healthier
and safer.
PYRAMID
03
Years of Corporate Experience
Partnering with Pharmaceutical
& Biotech Companies
30
Commercial Approvals
4
COMPANY OVERVIEW
Successfully Passed
Audits/Inspections
11
Hundreds of Clients Ranging from
Big Pharma to Biotech Startups
04
05
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 Product
Development Services on Clinical
and Commercial Scale
Preclinical
and Clinical Aseptic Manufacturing
Commercial
Aseptic Manufacturing
cGMP Labeling,
Storage, and Distribution
Method development, validation
and support testing
Pre-Formulation and Formulation
development for large and small
molecules
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 50,000
vials per shift
Lyophilization 23,000 -70 000 vials per
cycle
Stability Storage and Testing
Controlled Labeling
Controlled Temperature Storage
and 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
06
Three Building Campus Conveniently Located between
Los 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
BUILDING
A
BUILDING
B
BUILDING
C
. . . . .
John Wayne
LAX
San Diego
–
–
–
15 min
45 min
75 min
07
AIRPORTS
CLIENT FOCUSED
APPROACH
08
Technical Expertise
& Know-How
Flexible & Dedicated
Approach to Every Client
Multi-Year
Successful Collaborations
Quality
& On Time Delivery
Result Oriented
& Knowledgeable Client Teams
Project Management
09
APPROACH
QUALITY BASED
OPERATIONS
10
Quality Assurance Unit & Auditing
Program that are Organizationally
& Functionally Independent
Extensive Employee Training
Program Designed to Assure
Consistency & Compliance
Auditing Program that Monitors Compli-
ance With All the Applicable Regulations
& Guidelines
Documentation System that Details
the Requirements for All Tests & Processes
Documentation & Tracking
Procedures that Ensure Traceability
Change & Risk
Management System
11
QUALITY
ANALYTICAL SERVICES
12
Quality Assurance Unit Reviews 100%
of the Raw Data & Final Reports
Complex Method Development
for Large & Small Molecules
Including Low Solubility Compounds
Stability Studies for Prototype
Formulations, Clinical Batches
& Marketed Products
Method Validation Compliant with
cGMP/ICH
Over 4000 sq.f.
of Laboratory Space
Analytical Services Cover
Dozens of Methods from HPLC
/UPLC and LC/MS to LAL & PM
13
ANALYTICAL
PRODUCT
DEVELOPMENT
SERVICES
14
Formulation Optimization
& Development
Delivery Vehicles:
Liposomes, Nanoparticles, etc.
Lyophilization
Cycle Development
Small Molecules
Proteins & Peptides
Oligonucleotides
15
DEVELOPMENT
ASEPTIC
MANUFACTURING
16
Clinical Scale
Pre Filled SyringesLyophilization
Vials
Commercial Scale
Wide Range of Products:
Particles, Large & Small Molecules
17
MANUFACTURING
cGMP
WAREHOUSE AND DISTRIBUTION CENTER
18
Controlled Temperature
& Humidity Storage Area
Controlled Printing,
Labeling & Packaging
Clinical Trial
Material Management
Large Volume Capacity
Loading Docs for Trucks
Ambient / Refrigerated
Frozen / Ultra Low
Constantly Monitored
Stability Chambers
19
STORAGE
& DISTRIBUTION
PYRAMID Laboratories, Inc.,
3598 Cadillac Avenue
Costa Mesa, CA 92626
info@pyramidlabs.com
714.435.9585
www.pyramidlabs.com
714.435.9800 THANK YOU!

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Pyramid Laboratories Overview

  • 1.
  • 2. 30 years of successfully combining Quality, Performance & Integrity with individual approach to every Client 02
  • 3. Our mission is to provide clients with Top Quality reliable services assuring that their critically important parenteral products reach patients in need. By accelerating innovation, flexibility and efficiency we drive productivity and deliver on our mission to enable our clients to make the world healthier and safer. PYRAMID 03
  • 4. Years of Corporate Experience Partnering with Pharmaceutical & Biotech Companies 30 Commercial Approvals 4 COMPANY OVERVIEW Successfully Passed Audits/Inspections 11 Hundreds of Clients Ranging from Big Pharma to Biotech Startups 04
  • 5. 05 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 Product Development Services on Clinical and Commercial Scale Preclinical and Clinical Aseptic Manufacturing Commercial Aseptic Manufacturing cGMP Labeling, Storage, and Distribution Method development, validation and support testing Pre-Formulation and Formulation development for large and small molecules 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 50,000 vials per shift Lyophilization 23,000 -70 000 vials per cycle Stability Storage and Testing Controlled Labeling Controlled Temperature Storage and 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
  • 6. 06 Three Building Campus Conveniently Located between Los 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 BUILDING A BUILDING B BUILDING C
  • 7. . . . . . John Wayne LAX San Diego – – – 15 min 45 min 75 min 07 AIRPORTS
  • 9. Technical Expertise & Know-How Flexible & Dedicated Approach to Every Client Multi-Year Successful Collaborations Quality & On Time Delivery Result Oriented & Knowledgeable Client Teams Project Management 09 APPROACH
  • 11. Quality Assurance Unit & Auditing Program that are Organizationally & Functionally Independent Extensive Employee Training Program Designed to Assure Consistency & Compliance Auditing Program that Monitors Compli- ance With All the Applicable Regulations & Guidelines Documentation System that Details the Requirements for All Tests & Processes Documentation & Tracking Procedures that Ensure Traceability Change & Risk Management System 11 QUALITY
  • 13. Quality Assurance Unit Reviews 100% of the Raw Data & Final Reports Complex Method Development for Large & Small Molecules Including Low Solubility Compounds Stability Studies for Prototype Formulations, Clinical Batches & Marketed Products Method Validation Compliant with cGMP/ICH Over 4000 sq.f. of Laboratory Space Analytical Services Cover Dozens of Methods from HPLC /UPLC and LC/MS to LAL & PM 13 ANALYTICAL
  • 15. Formulation Optimization & Development Delivery Vehicles: Liposomes, Nanoparticles, etc. Lyophilization Cycle Development Small Molecules Proteins & Peptides Oligonucleotides 15 DEVELOPMENT
  • 17. Clinical Scale Pre Filled SyringesLyophilization Vials Commercial Scale Wide Range of Products: Particles, Large & Small Molecules 17 MANUFACTURING
  • 19. Controlled Temperature & Humidity Storage Area Controlled Printing, Labeling & Packaging Clinical Trial Material Management Large Volume Capacity Loading Docs for Trucks Ambient / Refrigerated Frozen / Ultra Low Constantly Monitored Stability Chambers 19 STORAGE & DISTRIBUTION
  • 20. PYRAMID Laboratories, Inc., 3598 Cadillac Avenue Costa Mesa, CA 92626 info@pyramidlabs.com 714.435.9585 www.pyramidlabs.com 714.435.9800 THANK YOU!