Welcome to ChemCon

5
C
Welcome to
ChemCon
chemical development
contract research
custom synthesis
cGMP API manufacturing
commercial production
stages as well as for commercial use. Today, more than 75 employees supply products and
services to North America, Europe, the Middle East, India, Japan and Australia.
1992: ChemCon´s roots date back to when one founder was involved in the development of synthesis strategies of active pharmaceutical ingredients at the University of Freiburg. Know-how acquired in this area forms the basis of the company´s success.
1994-2000: The two founders complete their PhDs in bio-inorganic chemistry peptide synthesis and rare analytical methods
which provides a
1997:
customer-oriented chemical services in Freiburg, Germany.
1998:
full GMP compliance.
1999:
2000:
to receive this proof of highest quality. The project, for which this inspection took place, receives the fastest NDA approval in
FDA history, achieved together with ChemCon´s customer. This demonstrates the high speed of our services.
2001:
2003: ChemCon starts in-house education, and develops its own well-educated scientists and chemical professionals following
2004: ChemCon receives the Baden-Wuerttemberg L-Bank Award, demonstrating excellent management skills. Our continuous economic development allows us to be a stable and reliable partner for our customers.
2009: ChemCon wins the STEP Award for its “dedicated-equipment-strategy” – the best option to avoid cross contamination
demonstrating the quality
of the whole operation.
2013: ChemCon receives approval from the German health authorities to start drug product manufacturing for clinical phases,
including development services.
clean room into operation.
Highest Quality
In Small Volumes
ChemCon – Good Manufacturing Partner
Customer services
Customer services
research and custom synthesis with
integrated custom manufacturing. Our
emphasis is on chemical development and
the manufacturing of small organic and
Our experience with multi-step chemical
synthesis, our versatile manufacturing
capabilities and our skilled employees make
ChemCon your good manufacturing partner
for a broad spectrum of custom synthesis
services - delivered on time, to the required
pharmaceutical ingredients (APIs) and
innovative chemicals for research purposes.
With our expertise in process optimization
and scale-up, while maintaining outstanding
product quality, ChemCon´s main strength is
the transfer from R&D into cGMP in our FDA
inspected clean room facilities.
We provide all necessary analytical and
regulatory services for supporting critical
project milestones. These services cover all
phases of drug development to regulatory
approval and commercial production with
cGMP compliance.
„We are focused on small
scale production of high quality
products and have excellent
experience in the synthesis
of small organic molecules,
APIs as well as HPAPIs.“
ChemCon – Good Manufacturing Partner
Early Stage R&D Services
Early Stage R&D Services
ChemCon adopts projects at all stages of
development, including projects from scratch,
early preclinical development and commercial
provides innovative organic and inorganic
chemical solutions to support timely and
ChemCon´s expertise and services include:
t
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literature research
route scouting and optimization
establishment of analytical methods
scale-up from mg to kg
You get:
t
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full intellectual property
synthesis know-how
analytical method development
technical grade APIs for:
- in vitro testing
- toxicity studies
- formulation development
ChemCon – Good Manufacturing Partner
Transfer to GMP
Transfer to GMP
The transfer of a chemical process
from the development stage to
GMP manufacturing is a challenging
and demanding task and the key
competence of ChemCon. Therefore,
an expert understanding and constant
improvement of production processes
and regulatory support is a key factor for
being successful in a competitive market.
ChemCon supports the transfer to GMP
for all clinical phases and provides the
services you need:
t manufacturing of small volumes in
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creation of all necessary documents
CMC section support
analytical validation
stability studies
You get:
t precise GMP documentation
t analytical release packages
t products for in vivo testing for
all clinical phases
t stability data
ChemCon – Good Manufacturing Partner
Commercial chemical and API production
Commercial chemical and API production
manufactures
valuable
Utilizing our long term know-how and ChemCon
advanced technologies we have all the chemicals of high purity on demand,
capabilities required to manufacture our experience in complex multi-step
synthesis of APIs. Our core strengths in
of compliance and are manufactured
following cGMP regulations according to t
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high containment operations for the
manufacturing of cytotoxic and other t
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highly potent APIs.
process validation
routine production up to hundreds of
kg
in-house regulatory support
handling of controlled substances /
HPAPI supply
t clean rooms to manufacture injectable, ophthalmic, oral or topic grade APIs
You get:
t routine API supply in small to
medium scale
t orphan disease APIs
t highly potent APIs
t controlled substances
ChemCon – Good Manufacturing
Man
Partner
Drug product manufacturing
Drug product manufacturing
In 2013 ChemCon received the approval
for drug product manufacturing for
human use in semisolid topic grade.
We plan to expand into this sector
and develop other dosage forms in
cooperation with our customers. With this
approach our manufacturing capabilities
are being expanded step by step and
designed to meet current and future
customer needs. With the development
and manufacturing of pharmaceutical
clinical trials or commercial supply for its
active pharmaceutical ingredients (APIs):
t stability studies
t development in cooperation with
partners
t
t manufacturing of placebos
range in drug development.
You get:
t drug product manufacturing in
small batches for clinical trials
ChemCon – Good Manufacturing Partner
Quality control
Quality control
ChemCon ensures the full scale quality our analytical and test equipment used
control of your project. Quality control is
performed on all stages of the process:
IQ-OQ-PQ.
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raw materials
intermediates
in-process controls
API release
Test methods can be either compendial (USP, EP, BP, JP), transferred from our
customer or developed by ChemCon. All
Analytical equipment:
NMR: 400 MHz, multinuclear; HPLC: DAD, UV, RI, ELS detectors; GPC; LC-MS; GC: liquid injection and headspace units, NPD, FID detectors;
GC-MS; ICP-MS; FT-IR: KBr, ATR, Film; Polarimeter; UV/Vis-Spectrometer; Rheometer; Titration equipment: KF, potentiometric, coulometric;
pH determination; MP determination; TOC determination; Polarized Light Microscopy; Ovens for LOD, ROI determination; Bulk density
determination; Wet chemistry analytical methods; Stability testing under common ICH conditions; Stress testing; Microbiological release
testing: bioburden and endotoxin level determination.
You get:
t method development
and optimization
t validation of analytical methods
t
t identity, quantitative and limit tests
t
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t ICH compliant stability studies
ChemCon – Good Manufacturing Partner
Quality assurance
Quality assurance
ChemCon has an outstanding track record of
inspections from German and US authorities.
As a chemical development partner to the
chemical, pharmaceutical and biotechnology
industries, quality is the center of our business
activities. We are committed to the highest
quality standards and the compliance
with EU and FDA regulatory requirements,
standard operating procedures and testing
methods. All services are performed following
or exceeding all current rules and regulations
for the protection of health, safety and the
environment. Every stage of the development
and manufacturing process is controlled
by our quality assurance (QA) team to meet
customer and regulatory expectations.
Through continuous quality management,
we ensure the constant improvement of
of our activities. Our quality management
system and independent quality assurance
organizations permanently guarantee that
our customers receive products and services
of the highest quality. Routine internal and
external quality audits for cGMP compliance
ensure that our quality systems are at the top
level of current industry standards.
„We have never received a critical
observation in the company´s history.“
Our customers regularly visit us to inspect
ChemCon´s quality assurance systems. We
have successfully passed approximately 100
customer audits, including audits from some
of the top ten pharmaceutical companies
worldwide.
t 4 x by US FDA (2000, 2007, 2011, 2014)
t 8 x by German (European) health authorities
(2003, 2006, 2008, 2011, 2x 2013, 2015)
t 15 x by health, safety and environmental agencies
t approx. 100 x by customers
t
ChemCon – Good Manufacturing Partner
Manufacturing equipment
Manufacturing equipment
As your partner in drug development,
ChemCon provides an advanced
environment containing cutting-edge
technology and capacity to perform
process research, development and
manufacturing. We operate state-ofthe-art equipment and currently have
over 25 fume hoods available for R&D
and production support activities.
This excellent infrastructure ensures
We are highly experienced and
equipped for handling a broad range
of organic and inorganic reactions,
embracing
sophisticated
modern
technologies, including low temperature
reactions, organometallic reactions,
chiral synthesis and hydrogenation at
capabilities applying chromatography or
chromatography services provide an
invaluable resource for producing earlystage material without recourse to
excessive development time or costs.
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various sized reactors up to 250 l
pressure reactors up to 100 bar
temperature range – 60°C to + 240°C
freeze dryers
FDA inspected clean room facilities
Class C + D
distillation equipment
milling equipment
centrifuges
parallel synthesis equipment
chromatographic separation equipment
ChemCon – Good Manufacturing Partner
Our four keys to your success
Our four keys to your success
Experience: more than 1000 projects completed
ChemCon has unrivaled chemical experience and expertise. We have already worked for 25 of the largest
chemical, pharmaceutical and biotech companies, completed over 1000 projects and produced more
than 100 APIs for all phases of drug development, including around 20 commercial APIs, since inception.
Quality: more than 100 different inspections aund audits successfully passed
health, safety and environmental standards in compliance with EU and FDA regulatory requirements
for cGMP manufacturing.
Customer orientation: your chemical challenge will be solved
The customer´s needs are the center of our activities. ChemCon scientists and technicians deliver
precise communication regarding project status as well as documentation for GMP or research purpose.
You will receive clear and accurate project updates on a weekly basis from your project chemist. Any
intellectual property generated by us under contract is owned by the customer.
Clear focus on early R&D stages and small to medium scale manufacturing
Small organic or inorganic molecules are our business and we are experts at what we do. Our focus
is on production volumes from small to medium scale in early research stages as well as commercial
manufacturing, including highly potent APIs.
„At ChemCon our whole
team is committed to serving
our customer´s needs.“
Dr. Raphael Vogler, CEO
ChemCon – Good Manufacturing
g Partner
Contact
Please contact ChemCon for your custom synthesis demands.
We will give your project the highest priority and personal attention:
ChemCon GmbH
Engesserstr. 4b
79108 Freiburg, Germany
Phone: +49 (0) 761-5597-0
Fax: +49 (0) 761-5597-449
E-mail: [email protected]
www.chemcon.com
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