Innovassynth
Introduction Document
2023
1
Group Overview
2
Innovassynth at a glance
Agenda
4
a
Key Product Portfolio
b
Success Stories
Advantage Innovassynth
1
The Rajan Raheja Group, is one of India's most diversified business houses,
with a portfolio of investments in professionally run independent companies
Diversified Portfolio
Group Revenue:
$4.5B
Group Market Cap:
$5.2B+
Capital Employed:
$2.4B
Group Employees:
>32,000
Automotive & Industrial Batteries
• > 65 % Market share in Automotive OE.
• ~47,000 outlets across India.
Real Estate development
• “Raheja” brand synonymous with best in
Real estate
Integrated Building material manufac.
• Cement, Ceramic Tiles & RMC
Media and Weekly news magazine
• Digital copy: >6 M unique visitors every month
IT & Software services
• Global Technology company
• 20 global locations/7 in USA
Apparel Retail
• Chain of 20 brand apparel stores in 12 cities
• >10 M footfall per year. 2M+ loyalty customer base
Cable television & Broadband
• One of India’s largest Cable broadband providers
General Insurance
• A Joint venture between Prism Johnson (51 %) &
QBE Australia (49 %)
Nucleosides, specialty chemicals and life sciences
Additional investments in Hospitality sector
• Co promotor of EIH Associated hotels along with Oberoi hotels.
(Trident Hotels/Oberoi Cecil, Rajvilas)
2
1
Group Overview
2
Innovassynth at a glance
Agenda
4
a
Key Product Portfolio
b
Success Stories
Advantage Innovassynth
3
Innovassynth: Who we
are and what we do
Innovassynth is a one-stop
solution provider for a
diversified portfolio of
chemicals including custom
development services
Our Mfg. Plant in
Khopoli, Mumbai,
India
Trusted partners for
Life Sciences,
Oligonucleotides, Specialty
Chemicals, & Organometallic
companies worldwide
Adherence to the highest
Quality and Safety standards,
and delivering cost-effective
products to the market
Our Headquarter and
Research & Technology
center in Pune, India
4
Innovassynth at a glance: Expertise acquired over last 2 decades
Infrastructure
People
Quality Standards
60+ acres of world class
infrastructure including mfg.
plant in Khopoli &
Headquarters in Pune
Total strength: 600+
ISO 14001:2015,
ISO 45001:2018,
ISO 9001:2015 & other
certifications
Manufacturing Capability
R&D Capability
Global Customer Base
10+ lines with total reaction
capacity of 250 KL
100+ scientists including
20+ PhDs,
30+ technical staff
100+ customers across life
sciences, nucleosides,
organometallics and specialty
chemicals
5
Innovassynth is divided into 3 business units, offering a widespread organic
chemical portfolio while also offering CRO services on an FTE basis
Life Sciences
• Phosphoramidite &
Nucleosides
• Reagents
• Delivery Platforms
(GalNAc)
• Bio-Buffers
• ADC Linkers
Specialty Chemicals
• Organometallics
including metallocene,
donors & reagents
• Niche Agri-Chem
chemicals, donors &
ligands
CRO & Emerging Biotech
• 75+ highly qualified
scientists
• Specializing in specialty
intermediates, bulk
chemicals for various
applications
• Flavor & fragrance
ingredients
Custom Development & Mfg. services
We also do custom development and toll manufacturing as per customer requirements
6
Innovassynth Advantage: Our value proposition is built around 5 pillars
A
Custom Development
& Mfg. services
Novel development capabilities
B
End-to-end development
& manufacturing services
as per requirement
State-of-the-art
mfg. facility
Investments achieving
long term cost
effectiveness
Research & Development
& CRO Capability
C
Quality Control
& Assurance
Focus to ensure highest
standards of quality & safety
D
E
Customer experience
High focus on deep
customer relationships
for diversified needs
7
A
Research &
Development
R&D center: Newly inaugurated Pune research & technology
park with state-of-the-art infrastructure & equipment
Facility Overview
FTE capabilities at a glance
• 24000 Sq.ft. state of the art facility for
R&D labs and corporate functions
Expertise in handling variety of chemistries
involving –
• 100+ staff, 75+ scientists
• Glycosidation reaction
• Tritylation and Phosphitylation
R&D capabilities
• 57 fume hood facility
• 10 HPLC (High-pressure liquid
chromatography)
• Multistep sugar synthesis
• Custom amidites synthesis
• Oxidation, reduction, rearrangement
• Friedel-Craft reactions
• 10+ GLC (Gas liquid chromatography)
• Cryogenic reaction, ex - Grignard
• Provision for special equipment like
• Suzuki reactions under Nitrogen
• Liquid chromatography–mass
spectrometry (LC-MS)
• Inductively coupled plasma mass
spectroscopy (ICP-MS)
8
A
Research &
Development
We work collaboratively across the product development
value chain to meet your product needs
RFQ|RFP
Sign-offs
Sampling
Pilot
Commercialization
Requirements
Technical
acceptance
Quality
checks
Pilot
production
Steering
Committee
Sample
Validation
Validation
Commercial
production and
supply chain
management
Commercial
Agreement
Testing
reports
Yield
Scope of
responsibility
Feasibility
study
Business case
75+ in-house R&D team working on customized solutions
9
B
Custom
Development
& Mfg.
services
We provide end to end development & manufacturing
services as per requirements
1
2
Development &
Dedicated
Scale up of
multi-ton custom
niche/novel
& toll mfg. plant
chemistries
3
4
Seamless
technology
transfer
Documentary
support & other
services
We have stood out as a time-tested longstanding custom
manufacturer for global companies
10
B
Custom
Development
& Mfg.
services
With product offerings across the nucleoside value chain
including niche and novel chemistries
1
2
3
4
Phosphoramidites
Nucleosides
Reagents
Delivery
Platforms
20+ products
20+ products
50+ products
50+ products
We are at advanced stages of completely backward integrating
the nucleoside manufacturing value chain
11
C
Quality
Control &
Assurance
High focus on quality and safety with state-of-the-art
labs and ISO certifications
Quality Control and Assurance
• State-of-the-art ADL and QC Lab- audited by multiple
global companies
• Impurity identification and characterization
• ISO9001:2015 based Quality Management System
• Change Control Management, Deviation Control and
CAPA Investigation, Documentation support for
regulatory filings
Environment, Health and Safety
• Strong accountability and engagement in EHS with a
state-of-the-art ETP with Zero Liquid Discharge.
• EHS preparedness on behavioral safety & zero
accident policy
12
D
State-of-theart mfg.
facility
Investments in State-of-the-art mfg. facility achieving
long term cost effectiveness through speed and scale
Capacity
• Multipurpose production facilities With >250 KL capacity and wide range
of working scales including: 50 L to 10 KL Reactor size
• Pilot, Medium scale and Multipurpose Plants dedicated for Nucleosides
• Few contract manufacturing tie-ups and land available for expansion
Equipment
• Equipment of various (MOC)| SSR: 44, MSGLR: 23, Glass AR:10
• ANF, ANFD, Centrifuge, Vacuum and Rotary Tray dryers
• Skilled team of engineers and supporting staff
Utilities
• Cooling water: 600TR
• Chilled water: 75TR/8°C,
• Chilled Brine: 66TR-20°C
•
•
•
•
Stream and Nitrogen: 3.5 Kg/Cm2,
Instrument Air: 5.5 Kg/Cm2
Hi-Therm oil: 220 °C
Acetone/Dry Ice: -70 °C
• Process & Demineralized water with Hot Air systems (35-90 °C)
13
E
Customer Experience: Innovassynth is a preferred partner of multiple global
oligo & life sciences companies
American
Nucleoside
Player
Innovassynth's prompt responses
& focus on customer
experience always stands out
The management is very happy
with progress in product
portfolio range
Global
Pharma
Giant
German Niche
Pharma Player
Impressive product quality &
speed to mfg.for custom
development requirements
American
Niche
Player
Innovassynth always strives to
improve product quality over
& above requirements
Large production facilities at
Innovassynth are one of its kind
in the entire Asian belt
Asian
Nucleoside
Player
American
Nucleoside
player
Our experience with Innovassynth has
been very smooth across R&D product
development collaboration stages
14
1
Group Overview
2
Innovassynth at a glance
Agenda
4
a
Key Product Portfolio
b
Success Stories
Advantage Innovassynth
15
Nucleoside product portfolio exhaustive covering multiple stages of
Oligonucleotide value chain
Phosphoramidites
•
•
•
•
•
•
•
•
•
•
2' OMe
2' OMOE
2' F
D-RNA
L-RNA
cEt
LNA
Deoxy
Customized amidites
…
Protected
Nucleosides
• Protected
nucleosides/Diols
• 2' OMe
• 2' OMOE
• 2' F
• D-RNA
• L-RNA
• cEt
• LNA
• Deoxy
Reagents
•
•
•
•
•
•
DMT-Cl
Phos reagent
Methoxy phos reagent
Tac Acid/Tac- Cl
TBAP
…
Delivery Platforms
& Others
• GalNAc
• Bis Benzyl Ribose Sugar
Mannopyranoside
• …
16
Reagents & Delivery agents: Multiple products across the nucleoside value
chain supplied commercially
DMT-Cl
Methoxy Phos
Phos Reagent
Tri GalNAc Succinate
O M e
M e O
M eO
Cl
O
N
P
N
• Protecting group with stringent
& customized specifications.
• Easier to handle -OMe phos
reagent, in place of -CN i
• DMT protection essential for all
nucleoside Phosphoramidites
used in Solid—phase
Oligonucleotide synthesis
• Used in the synthesis of
Oligonucleotides as building
blocks of RNA/DNA—based
drugs
• Major supplier for South Korea,
USA, Europe, China
• Purity >99%
• Annual Capacity > 30MT
• Lab Sample Available
NC
O
N
P
N
• Challenging to prepare due to
chemically similar impurities
being generated.
• Very sensitive GalNAc chemistry
• Used in the synthesis of
Oligonucleotides used as
building blocks of RNA/DNA—
based drugs
• Very stringent specifications
• Purity >98%
• Ready to commercialize
• Control of M-14 impurity to
obtain high quality
• Deliverables include
development, process
optimization and supply of
high quality amidites for
qualification
• Lab Sample available
17
Life Sciences product portfolio: ADC Linkers, Bio Buffers & Intermediates
cTEG
• Commercially difficult
to manufacture
macrocycle
• ADC linker used in the
synthesis of
antibody—drug
conjugates (ADCs
• Annual Capacity > 5MT
TCEP
DMCH
• TCEP is used as a
reducing agent
• Pharma RM for
Venetoclax
• Used in the tissue
homogenization process
for RNA isolation
• Example of Grignard
reaction
• Purity >98%
• Purity >99%
HEPES
• Good’s buffer used
widely in biochemical
reactions and as a
buffering agent in cell
culture
• Good’s buffer with a pKa
of 6.15 used as
non-coordinating buffers in
chemistry, and
biochemistry
• Membrane impermeable
• Stable to temperature,
chemically & enzymatically
• Limited effect on
biochemical reactions,
very low visible and
ultraviolet light
absorbance
• Annual Capacity > 20MT
• Annual Capacity > 1MT
MES
• Annual Capacity > 15MT
• Very low visible and
ultraviolet light
absorbance
• Annual Capacity > 15MT
18
1
Group Overview
2
Innovassynth at a glance
Agenda
4
a
Key Product Portfolio
b
Success Stories
Advantage Innovassynth
19
A
Success Story
Research Development & Scale up Success Story: End-to-end development of
therapeutic grade L-RNA amidites
Scope
Develop commercially viable process for manufacturing of L-RNA amidites with stringent specifications
Achievement
Customer appreciation for supply reliability, Quality On Time In Full (QOTIF) and cost benefits for supplying
commercial scale (150+ Kgs, All monomers) multiple orders for Clinical Phase 2/3
Approach
B
Challenges
ODMTr
O
OR
OR'
R= -TBDMS, R'= -CEPA
B = A, G, U & C
• Sensitive RNA chemistry
with stringent quality
specifications
Strategy
• Synthetic approach
designed for impurity
control with our
extensive RNA
• Prone to formation of
chemistry expertise
critical migrated impurity
• Identification of process
• Deliverables include
control parameters
development, process
including, what if
optimization and supply
studies, IPC, stability etc.
of high quality amidites
to finalize the protocol
on commercial scale
Development
• Impurity profiling and
control of critical
impurities with robust
processes
• Process optimization
• Analytical method
development including
LCMS for impurity
monitoring
Scale up
• High-quality commercial
scale reproducible
campaigns
• Achieved improved yields
by replacement of
column chromatography
with crystallization
• 15-50 kgs various monomer
amidites supply for clinical
phases
20
B
Success Story
Custom development & commercialization of MMP (α-Methyl-D-mannopyranoside)
Scope
Develop commercially viable process for manufacturing of high quality MMP within stipulated timeframe
Achievement
Developed & Commercialized MMP with overall high-quality. Enhanced the production capacity to dispatch
~14MT by mutually agreed dispatch date
Approach
Challenges
• Stringent specification
• Control of specification
particularly SOR and MP
H O
• Control of undesired
critical impurity
O
O H
• High reaction volume
H O
O H
O C H
M M P
Strategy
• Sourcing of high-quality
RM
• Designing and
optimization of the
process
• Process validation and
commercial viability
• Capacity enhancement
3
Development
• Identification and
incorporation of critical
reagents to control
critical impurities and
product quality
• Process optimization
• Volume optimization to
enhance the productivity
Scale up
• Robust commercial scale
reproducible process
• Achieved improved yields
• Supplying repeat orders
with greater efficiency
within stipulated
timeframe
• Analytical method
development at RI
21
C
Success Story
Cost Efficiency Success Story: Commercial & cost competitive manufacturing of
large scale 2’F monomers with control over evolving stringent specification
Scope
Quick development of the commercial manufacturing process with the controlled critical impurities
Achievement
Successful economical process development with evolving stringent specification rewarded with repeat POs
Approach
Challenges
• Stringent specification
D M T rO
O
B
O R
F
R = -H , -C E P A
B = A , G , U & C
F lu o r o m o n o m e r s
• Control for specification
while developing the
process within timelines
• Deliverable included
development, process
optimization and supply
of high quality PNS for
qualification
Strategy
• Identification of Process
control parameters
including DOE, what if
studies, IPC, stability
etc. to finalize
the protocol
• Dedicated crossfunctional team
including engineers &
analytical constituted
with a technical lead
Development
Scale up
• Effective project
management across
stakeholders
• 25kg supply of each
monomer meeting all
quality requirement
• Analytical method
development &
alignment for IPC and
final release
• 250kg of each monomer
delivered
• 650kg PO execution
is in progress
• Periodic technical
communications &
collaborations;
alignment on continuous
improvements
22
D
Success Story
Custom development & commercialization of Macrocyclic Compound-ADC Linker
Scope
Partnering with drug discovery companies to develop ADC linker intermediate
Achievement
Supplying x100kg of product for drug development to global customers
Approach
O
• Macrocyclic compound
synthesis has the major
challenge in avoiding
dimers, trimers, and
oligomers
O
S
O
O
O
O
O
cTEG
Challenges
• Stability of the
compound and complex
purification combined
with analytical method
development
• Scale-up will be a major
challenge
Strategy
• Identification of critical
impurities and
developing an easy
purification process
• Improve the stability of
the intermediate by
controlling temperature
Development
• Stage-1 was found to be
highly unstable and tend to
degrade during isolation.
The reason was identified,
and was successfully
implemented
• A simple purification
process was developed to
remove the dimer and
trimer
Scale up
• Stage-1 Dimer and trimer
were initially difficult to
control leading to lower
yield. This was overcome
by adjusting the flow rate
and reversing the
addition sequence
• Final stage - melting
issues during filtration,
we have done humidity
control and temperature
control to sort out the
issue
23
E
Success Story
Quality Success Story: Development and commercial manufacturing of high
quality GalNAc Pentanoic Acid
Scope
Development of the economically sustainable commercial process without M-14 critical impurity
Achievement
Developed economical sustainable process with very high quality & yield and without M-14 critical impurity
Approach
Challenges
• Sensitive GalNAc
chemistry
O
R
R
• Low yielding, nonscalable process
O
O
O
• High purity
O
O
O
O
specification with
R
O
O
H
critical impurity
N
H
O
R
=
C
H
,
B
z
3
control
G
a
l
N
A
c
P
e
n
t
a
n
o
i
c
A
c
i
d
Strategy
Development
Scale up
• Identification of
efficient route to
achieve high quality &
commercial
sustainability
• Development of scalable
process to eliminate
M-14 impurity effectively
• Efficient large-scale
manufacturing
established
• Development of suitable
analytical methods
• Process optimization
• Validation and scale
up to commercial scale
done in short period
of time
• >30kg of high-quality
material supplied
for further
derivatization
• Control of M-14
impurity for high
quality output
24
1
Group Overview
2
Innovassynth at a glance
Agenda
4
a
Key Product Portfolio
b
Success Stories
Advantage Innovassynth
25
Global supply chains under stress, imperative for businesses to improve resilience
with diversified sources
COVID and multiple geopolitical events causing stress
Tariffs and trade barriers
COVID
Leading to supply and cost
impacts across supply chain
Commodity shortages
Leading to higher commodity
prices
Component/product
sourcing challenges
Due to plant closures/lockdowns
BREXIT
Ukraine war
South China sea
And few more….
Demand shocks
Inability to import/export,
subdued consumption
Rise in Logistics costs
Capacity constraints &
increasing fuel costs
With key strategic implications for
leadership to consider
Short-term:
• Prioritize customers to protect
• Find alternative sources
• Rebalance global network
Mid-to-long term:
• Optimize global footprint
with multiple sources
• Friend-shoring: Work with
allied nations and trusted
supply sources
• Plan Capacity and Re-set
supply chain buffers
26
Within APAC - China is the largest CDMO market but India fastest growing
presenting significant future potential…
APAC CDMO market – by country ($B)
CAGR (2022-26)
31
29
China
7%
India
9%
Japan
3%
Australia
4%
Others
4%
27
24
22
20
18
16
11
10
9
3
2 3
2019
China
4
3 3
2020
India
4
3 3
2021
Japan
4
3 3
2022
Australia
17
16
14
13
4
3 4
2023
19
4
3 4
2024
Others
1. Prominent countries in others segment include S.Korea, Singapore, Malaysia and Taiwan
Source: Global CDMO market – Mordor Intelligence
4
3 4
2025
5
4 4
2026
27
Global macro trends to drive exponential growth in the India Chemicals
industry which ranks amongst the top 5 globally
At $178 Bn of annual production, India
comprises 3~4% of Global Chemical industry
Chemicals
output ($Bn)
% of Global
chemicals output
300
5
+5%
4.0%
3.4%
200
100
2.4% 2.3%
106
0
Indian Chemical Industry is expected to
reach $300Bn by 2025
110
2.1% 2.0% 2.1%
115
124
127
2.3%
143
2.4%
156
3
2.6% 2.6% 2.4%
161
169
169
168
178
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
India
4
2
1
Unprecedented growth post 2020 due to
• Consumption economy & niche products
• Rapid import substitution
• Geo-strategic demand shift from China
• Bilateral and regional FTA Agreements
• Specialty chemicals account for more than
50% chemical exports
• Expected to grow the fastest till 2025
• Critical to block capacity in advance for
future supply
India output as % of Global output
1. GVA = Gross Value Added
Source: Oxford Economics, Invest India, Department of Chemicals and Petrochemicals, NSSO
28
Advantage
Innovassynth
1
20+ years of life sciences exp, and expertise in the nucleoside space
• One-stop solution provider for varied compounds including niche amidites
• Strong ability to customize solutions as per customer requirements
• Trusted partners to the biggest global oligonucleotide players
We provide a
highly competitive
offering to meet
your supply chain
requirements
with…
High capability in working with amidites for development & scale-up
2
• End to End solutions, from ideation and development to scale up & deliveries
• Recent investment in new R&D center to cater to evolving market requirements
• Multi Kg scale manufacturing lines, ability to invest further capex as required
• Experienced & highly qualified set of 100+ scientific staff including several PHDs
3
High focus on offering competitive pricing
• Backward integrated supply chain which can cater to flexible demand schedules
• Strategic sourcing partnerships globally to improve costing
• Constant endeavor to reduce cost with scale to ensure commercially competitiveness
29
We are open to different forms of partnership based on your needs
Custom
Research
Co-development
& Manufacturing
End-to-end
development &
Manufacturing
Contract
Manufacturing
30
Uncompromised EHS culture engrained at Innovassynth
Thank You
31