AMBIOPHARM, INC. Peptide API Manufacturing and Services 2021
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AMBIOPHARM, INC.Peptide API Manufacturing
and Services
2021
History of AmbioPharm
AmbioPharm registered in California, USA
AmbioPharm, FDA PAI
2013
AmbioPharm, FDA cGMP audit
AmbioPharm acquired UCB Bioproducts at North Augusta, USAShanghai AmbioPharm, started in Shanghai, China
2005
2007
2011
AmbioPharm, FDA PAIShanghai AmbioPharm, FDA PAI
2014
2016Shanghai AmbioPharm, FDA cGMP audit
2017 AmbioPharm, FDA PAI
2015 Shanghai AmbioPharm, new commercial manufacturing facility built
2020AmbioPharm, North Augusta, USA
building expansion completed; Shanghai AmbioPharm ongoing new construction
Shanghai AmbioPharm Administration-R&D building in operation; buildings 2-4, ongoing construction2021
AmbioPharm Organization Chart
CEOChris Bai
VP of QC and Analytical
DevelopmentSherry Li
Sr. VP of QualityBrant Zell
Sr. Director of Quality Assurance
Sue Soderholm
CFOStephen Kiel
Executive VP and Head of QAIsabel Tan
GM of Shanghai AmbioPharm
Fei Wang
CSOMike Pennington
Chief EngineerJinbao Zhang
VP of Process Development and
ManufacturingGuoqing Zhang
Sr. Director of Technical Operation
Emory Gunter
VP of Manufacturing Mukesh Patel
COOTim Nieters
Sr. Director of Quality Control
Selvaraja Elumalai
Executive VP of Sales and Business
DevelopmentJim Hampton
Sr. Director Sales –Australia, North &
South AmericaRob Cissell
VP Sales - EuropeKathleen Noack
CFO
Steve Kiel MBA, CPA
COO
Leading Management Team with Deep Biologic and Pharma Expertise
Chris J. Bai, Ph.D.
25+ years experience in Peptide development and manufacturing
Oversees Ambio and its U.S. and China operations.
President & CEO
Tim NietersMBA
Senior VP of Quality
Brant ZellMS, MBA
Senior VP of Business Development
Robert GeigerPh.D., MBA
CSO
Mike Pennington Ph.D.
Executive VP of BD and cGMP Sales
Jim Hampton BS
VP of Manufacturing
Mukesh PatelMS
VP, Manufacturing and Process Development
Guoqing Zhang BS, MS
VP Sales -Europe
Kathleen NoackMS
Track Record of Regulatory Compliance
Consistent quality and compliance with all FDA/EMA/NMPA inspections
FoundedAmbioPharmwas foundedin 2006
2006 2011
FDA Approved BivalirudinThe 1st
commercial API
2015
2011
FDAInspection of US SiteComplies with cGMP
2013 2016
EMA Approved Bivalirudin & FDA Inspection of Shanghai
The 1st EU approval
NMPAInspection of Shanghai SiteComplies with cGMP
FDA PAI of US SiteComplies with cGMP
2017
The 1st NCE commercial API
FDA Approved Plecanatide
What we offerPeptide API Manufacturing and Services
GMPServices
Non-GMP Services
Generic Peptides
Vaccine Services
Analytical Development& Validation
Multiple manufacturing suites
capable of producing peptide APIs
at varying scales from gram to
multi-kilogram scale.
Provide process development and
analytical services for non-
GMP/GLP grade peptides.
Partner with generic drug
companies to develop generic
peptide drugs for established
commercial markets throughout
the world.
Has years of experience
manufacturing APIs for peptide
vaccines in varying configurations.
Analytical HPLC or UPLC
methods and validation tools will
be developed as the process
development is underway.
State-of-the-art infrastructure
State-of-the-Art Peptide Process Development and Manufacturing
One of the world’s largest cGMP peptide manufacturing facilities
Specialized peptide know-how International regulatory accreditation
Best-in-class capabilities and capacities
Strategic global operations with FDA-inspected facilities in US and China
200kg+ Annual peptide API production between U.S. and Chinese facilities
16 Manufacturing lines 3,000L solid phase reactor 5,000L solution phase reactor
500+ Chemists and professionals, with 40+ Quality Assurance staff
Technology-enabled analytical development and manufacturing
Production at varying scales (g to >100 kg) and every phase of development from pre-clinical to commercialization
Peptide manufacturing facilities in North Augusta and Shanghai, both with cGMP standards under FDA regulations
Significant cost advantage
New production suites, QC and micro labs online in 2020
Dual U.S. and China peptide development and manufacturing platform of scale
AmbioPharm Facilities and Offices
210 employees staff the USA based facility
where a huge expansion project was
completed and qualified in May 2020. In
addition to the current 26,000 square foot
facility, two additional freestanding
buildings total an additional 56,000 square
feet of manufacturing space. The new
buildings include suites to increase our
capacity for purification, formulation, and
final product development in the U.S.
In Shanghai, China, 350 chemists are
doing all of the synthetic chemistry that’s
driving our business. An impressive state-
of-the-art campus in Shanghai is currently
under construction and will more than
double our synthetic capacity. Our newest
commercial building has four additional
large-scale manufacturing lines.
USA Headquarters Shanghai, China
Swiss Sales Office
AmbioPharm Shanghai HQ Expansion
• The Shanghai facility is an entirely
new campus dedicated to commercial
peptide manufacturing. Four
buildings are currently under
construction and will add more than
35,000 sq. meters to our facilities.
• The Administration-R&D building
construction was completed at the
end of 2020.
• Production buildings 2 and 3 are
under construction.
• Included in the new Shanghai facility
is a waste recycling and recovery
unit to improve our green
footprint allowing us to recover both
MTBE and DMF from synthesis and
MeCN from purification.
• Building 4 is under construction.
Shanghai HQ Expansion Shanghai, China
Wastewater treatment / WWTP
Workshop 1:Hydrogenationreactor room & solvent recovery system
Workshop 2:S to N: synthesis suites(pilot scale);E to W:1st-3rd floors, synthesis suites(large scale);4th floor: purification suites;
Workshop3: 1st - 3rd floors, synthesis suites (pilot & large scale)4th floor: purification suites
Shanghai HQ R&D Building
“Green Chemistry” : solvent recovery system for main solvents DMF, MTBE and acetonitrile
Shanghai R&D and QC have moved into the new HQ R&D BuildingHQ Building No. 2 will be available for GMP pilot synthesis at kg scale soon
Green Chemistry Initiatives
Microwave Synthesis
Solvent Recovery
Process Efficiencies
Greener Reagent Use
Green
Chemistry
New Shanghai Admin-R&D Building
R&D CapacityFacilitate Peptide Discovery and Optimization
Key R&D Equipment
Synthesis:CEM Liberty Blue SynthesizerManual Glass ReactorsLarge Scale SPPS Reactors
Purification:Shimadzu and Agilent analytical HPLC SystemsMultiple HPLC self-pack axial pressure columnsSG100 Protein Purification SystemHPLC automated Semi-Prep HPLCProduction & analytical MS & HPLC Systems
AmbioPharm U.S. Expansion and Virtual Tour
U.S. Expansion
Shanghai, China
The North Augusta expansion added
nearly 60,000 sq. ft. of manufacturing /
purification space as well as additional
QC and Microbiology labs.
Manufacturing Operations began on
May 15, 2020 in Bldg. 500.
NASC Building 500: New Manufacturing Suites
• New 45 cm Column Purification Suite• New 60 cm Column Purification Suite• New 100 cm Column Purification Suite• New Lyophilizers 400L (2)• New Lyophilizer 800L (2)• New Lyophilizer 1000L (1)• New Precipitation/Crystallization Suite (12/31/20)• Currently evaluating addition of a Spray-Drying Isolation Suite• 3 New Synthesis Suites in Q2 2021• Liberty Pro Microwave synthesizer for GMP production
Crystallization/Precipitation Equipment installed at NASC Bldg 500
Buchi R250- 50L Rotary Evaporator and Chiller
Pilot Plant Scale Equipment
R&D Services Portfolio
Custom PeptidesHTP, Scale-Up
Complex & LongPeptides.
Process Development
GMP ServicesComplete technical report
Clinical
Process Development
Plan ASPPS synthesis inFmoc-tBu format
Process Development
Plan BHybrid methods if
SPPS is warrantedPlan C
LPPS methods when deemed best
01 Scouting synthesis run in a fully automated approach
02 Scale up with optimized synthesis protocol manually03
Develop preparative HPLC conditions, then scale up purification
05 QC Specifications and technical Document preparation
04 Establish RP-HPLC method for purity, salt-exchange, lyophilization
optimal choice of resin, substitution,building blocks and protecting groups
cleavage, oxidation/folding optimization
Our cGMP Model
Crude Synthesis
Purification
PO
Final ReleasePurification
Delivery
Final Release
Performed at Shanghai AmbioPharm
Performed at U.S. AmbioPharm
Either Shanghai-AmbioPharm or U.S.-AmbioPharm
GMP ServicesQuality Management
ChangeControl
CAPA DeviationManagement
SelfInspection Compliant
Product Release
QualityReview
PersonnelResponsibility, Qualification, Training
Equipment and BuildingGood Engineering Practice (GEP)
EnvironmentMonitoring System
MaterialVendor Qualification, Storage and Delivery
ProductionTech-Transfer, Process Control, Re-process
Quality ControlLaboratory Management, OOS
ReleaseBatch Record Review/Release, Product Release
AmbioPharm Experience in Peptide Projects
Solid
Hybrid
Solution
CapabilityCapacity
10 - 3,000 L reactors
10 - 5,000 L reactors
10 - 5,000 L reactors
Cost effective for peptides longer than 10 amino acid residues
Faster development time
Complex peptides
Long peptides
Scalable up to 100kg
Cost-effective for shorter peptides Scalable to metric ton Avoid HPLC chromatographic
purification for certain conditions
Largest peptide manufacturing
capacity and actively expanding capacity
Over 200 years cumulative
management experience in cGMP
Highest technical Capabilities in peptide
industry
Achieve cost advantages by
leveraging production across US and
Chinese facilities
Setting a new standard for the
quality of generic APIs
Three manufacturing facilities to serve
customers worldwide
Capacity Experience Capability Economic Quality Globalization
AmbioPharm Advantage
Shanghai AmbioPharm started moving to the new manufacturing campus at the of 2020. We would synthesize your future peptide at our new Shanghai manufacturing campus.
We can perform downstream purification at our Shanghai Building No. 13 or our North Augusta, SC site.
AmbioPharm’s team has a 14-year history developing feasible & scalable peptide processes to commercial scale >100kg/year.
We have rich experience in developing crystallization and precipitation process for peptide APIs.
In addition to our 1,000 L lyophilization capacity, we are working to install spray drying equipment to achieve even larger-scale batch isolation.
Summary – Purification and Isolation
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