You deserve an advantage

You deserve an advantage
Your Pharmaceutical Chemistry Partner in:
• Chemical Process R&D
- organic and inorganic -
• Transfer into GMP for Clinical Trials
• CMC Section Support
• Routine GMP Production
Orphan Drugs
High Potency API
High Value API
Your Project
Drug
Discovery
Clinical
Phase I
pre-clinical
feasibility
Clinical
Phase II
route finding
process optimization
Chemical Process R&D
Transfer into GMP
- organic
- inorganic
- g to multi kg
- process development
- first clinical material
- dedicated equipment
- analytical validation
- stablity studies
cGMP
Manufacturing
Clinical
Phase III
scale-up
routine production
Commercial Production
CMC section support for
DMF/ASMF/NDA filings
- small to medium scale
- injectable, oral, topic grade
- highly potent
- Orphan Drugs
- dedicated equipment
- process validation
- FME Analysis
- impurity profile
- CTD format
Our Services
CHECKLIST: Questions to ask your Chemical Service Provider
You might wish to consider the following points when selecting your Supplier:
ChemCon
other CMO
þ ¨
þ ¨
þ ¨
Experience with highly active substances
Range from early process development to
commercial production
Experience with creation of CMC-sections
for DMFs and ASMFs Qualified QA support through all project stages
þ ¨
Impeccable FDA and EU-GMP inspection history
þ ¨
Broad experience with manufacturing under
cGMP and ICH7 guidelines
þ ¨
Excellent quality of GMP documentation
þ ¨
Project manager dedicated to your project þ ¨
Commitment of top-level management
þ ¨
Excellent quality reputation þ ¨
Use of dedicated equipment to avoid cross contamination þ ¨
You own all IP generated under a contract þ ¨
Final
Dosage
Form
YO U R N E E D S
O U R S E RV I C ES
YO U A R E LO O K I N G FO R
ChemCon
• Chemical Process R&D
- organic and inorganic • Transfer into GMP for Clinical Trials
• Analytical and Process Validation
• CMC Section Support
• Routine GMP Production, i.e.:
Orphan Drugs
High Potency APIs
High Value APIs
Controlled APIs
YO U R EQ U I R E
• Counsel and full service through the
chemical part of a drug application
• Perfect documentation leading to fast
regulatory approval
• Personal attention only an owner-operated
business can give
• One supplier from early research stages to
commercial production
You found it - ChemCon is your good
manufacturing partner.
offers
completely
integrated
custom manufacturing. Our expertise is in
process optimization, scale-up and production
from milligrams to multi-kilograms. We also
provide all necessary analytical and regulatory
services for supporting your critical project
milestones. Our services cover all phases
of drug development including regulatory
approval
and
commercial
production.
All work is done fully cGMP-compliant.
ChemCon´s
• experience in multi-step chemical synthesis
• versatile manufacturing capabilities
• skilled employees
make us your good manufacturing partner
for a broad spectrum of custom synthesis
services. We deliver on time, to the required
specification and cost-effectively.
Please contact us today for a fast and reliable
quotation.
C H E M I C A L D E V E LO P M E N T
With our stringent good manufacturing
practices and regulatory compliance, we have
Chemical development is the main focus of
prepared numerous CMC sections for clients’
ChemCon´s business activities. We are working
IND, NDA and ANDA filings. Dedicated project
for the pharmaceutical, biotechnological and
managers work in close communication with
chemical industries.
our analytical department and QA to ensure a
Our highly qualified team provides all the
fast and smooth transfer into cGMP.
synthetic services you need:
Our regulatory affairs staff possesses exten-
• route scouting and optimization
sive
• feasibility studies
the commercial phase. We are currently
• custom synthesis (R&D material, inter­
manufacturing for multiple active DMFs.
mediates, building blocks, derivatives, etc.)
ChemCon uses dedicated equipment for each
• synthesis or isolation of impurities and
project once the production is under cGMP.
degradation products for reference standards
This is the most effective way to ensure there
• scale-up
is no cross contamination.
experience
bringing
projects
into
• chemical process development
• GMP material for clinical trials
• process validation
In-house QC and full documentation are an
integral part of our service portfolio.
G M P M A N U FAC T U R I N G
Q UA L I T Y CO N T RO L
Your project is completely safeguarded by our
QC team. Quality control is performed on all
stages of the process:
• raw materials
• intermediates
Project transfer from R&D into cGMP is the
• API
core competency of ChemCon. Do you need
Test methods can be either compendial (USP,
an API for clinical trials or Orphan Drugs?
EP, BP, JP) or tailored methods, which we
We manufacture even small volumes of your
transfer or develop for our customers. We
product in cGMP quality for toxicology and
offer thorough validation of analytical release
clinical studies phase I to III.
methods and processes.
H PA P I
manufacturing of HPAPIs in multi-kilogram
ChemCon offers High Containment Operations
quantities with OEL levels <0.01µg/cbm.
for the manufacture of cytotoxic and other
highly potent APIs. The low OELs for such
substances require complete containment and
special handling during processing. The second
API ChemCon ever produced was a high potency
compound. So with 15 years of experience
in
development
and
commercialization,
ChemCon understands the challenges that
come with producing such HPAPIs.
Our
pharmaceutical
development
manufacturing
capabilities
manufacturing
under
utilizing
cutting-edge
include
cGMP
and
HPAPI
conditions,
technology,
our
comprehensive product experience and rigid
training procedures. ChemCons safety and
environmental team ensures that compound
potency is considered during all handling
operations. When it comes to HPAPI production,
ChemCon´s strategy of dedicated equipment
proves even more valuable to safely exclude
even the slightest cross-contamination.
In reaction to the constantly growing worldwide
demand of cytotoxic and other highly potent
active pharmaceutical ingredients (HPAPIs),
ChemCon is adding containment for the
Q UA L I T Y
ChemCon only delivers services or products
conforming to our strict quality standards. We
perform work to the highest quality standards
and comply with EU and FDA regulatory
requirements, company operating procedures
and testing methods.
All API batches bearing a Certificate of
Compliance are manufactured in accordance
with current Good Manufacturing Practices
following the ICH Q7 guidelines.
Quality reviews by our independent Quality
Assurance department ensure the effectiveness
of our quality system and of corrective
and preventative actions (CAPA). Routine
internal and external quality audits for cGMP
compliance assure that our quality systems are
at the top level of current industry standards.
Our customers regularly visit us to inspect
ChemCon’s quality assurance systems. We
success​fully passed over 80 customer audits.
Included are audits by several of the top 10
The company values your business: All IP
pharmaceuticals companies worldwide.
generated during a project is your sole property.
• 3x by the US FDA
• 4x by German (European) health authorities
• 15x by health, safety and environmental
agencies
• more than 80x by customers or their
consultants
• ChemCon also is an ISO 9001:2008 certified
company
We have never received a critical observation
in company history.
CO N TAC T
Please contact ChemCon to discuss your custom
synthesis needs. We will give your project high
priority and personal attention.
ChemCon GmbH
Engesserstr. 4b
79108 Freiburg
Germany
C O M PA N Y
ChemCon has a 15-year track record of
experience, quality and delivering results. We
are an independent supplier and provider of
chemical services.
Fon: +49 (0) 761 5597 440
Fax: +49 (0) 761 5597 449
E-Mail:
[email protected]
URL: www.chemcon.com
Smartphone: m.chemcon.com
ChemCon is operating from a FDA-inspected
facility in Freiburg, Germany. We have a global
footprint: Our APIs are regularly marketed
in North America, Europe and Asia and we
systematically expand into developing markets.
ChemCon has completed over 500 projects
In-house Analytical and Test Equipment
since inception and produced more than 50
All equipment used for QC is fully qualified for cGMP with DQ-IQ-OQ-PQ:
APIs for all phases of drug development as well
as commercial production.
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NMR: 400 MHz, multinuclear
LC-MS
HPLC: DAD, UV-, RI- and ELS-detectors
GC: Liquid injection and headspace units (NPD, ALS, FID)
FT-IR (KBr, ATR, Film)
Polarimeter
UV/Vis-Photospectrometer
Metrohm Titrando for KF titration, potentiometric titration
Coloumeter for Karl Fischer water determination
pH-determination
Melting point determination
Ovens for determination of Loss of Drying
Muffle furnace oven for Residue of Ignition
Rheometer
Gel Permeation Chromatography
Microbiological safety laboratory (S2 certified) for microbiological limit testing, identification of pathogens and endotoxin
testing
Stability chambers for stability testing on APIs
25°C,60%RH
5°C
40°C,75%RH
-22°C
30°C,75%RH
Directions to ChemCon
© OpenStreetMap contributors, CC BY-SA; www.openstreetmap.org; www.creativecommons.org
From North/Northwest (France, via Strasbourg),
Southwest (France, via Mulhouse) or South (Switzerland):
From East (Hoellental/Donaueschingen/Singen)
• Leave Autobahn A5 at Freiburg-Mitte (exit 62), general
direction Freiburg
• Drive on highway B31a for about 2 km, at the 2nd exit
follow the direction “Messe/IKEA”
• Follow the road for about 4 km, at the 2nd traffic light
turn right (Tullastraße). After passing the REWE supermarket on your right side, turn right at the roundabout into Engesserstrasse (1st exit)
• Follow the road for 200 m then turn right into the
second entry of the BioTechPark, Engesserstraße 4b,
behind the four-story building with green window
frames
• Please proceed below the connecting passage between the green and
red window framed
buildings. ChemCon´s
guest parking lots are
located beyond the
buildings
• Enter Freiburg through the city tunnel (highway B 31)
• Beyond the tunnel, turn right and follow the street
(Schlossbergring - Leopoldring)
• Turn right into Habsburgerstrasse and follow that road
(highway B3) for about 3 km
• Take a left turn into Tullastrasse and proceed until the
first roundabout (Aldi, REWE)
• Take the third exit from the roundabout, entering
Engesserstrasse
• Follow the road for 200 m, then turn right into the second entry of the BioTechPark, Engesserstraße 4b, behind the four-story building with red window frames
• Please proceed below the connecting passage between the green and red window
framed buildings. ChemCon´s
guest parking lots are located
beyond the buildings.
W H Y C H O O S E C H E M CO N?
8 reasons to place your trust in us:
Proven track record
Confidentiality/Intellectual property
We realized projects for 26 of the TOP 50 global
ChemCon is held by the two owners, completely
chemical, pharmaceutical and biotech companies,
independent and not affiliated with other
for more than 150 small and midsize Biotech
companies. Confidentiality is guaranteed by the
and Pharmaceutical companies, for 23 Research
founders. You own any intellectual property
Institutions/Universities and 11 international
generated by us under a mutual contract.
trading companies.
Impeccable inspection history
Flexibility
ChemCon as an owner-operated company stands
Up to date we were inspected/ audited by the FDA
for quick decision-making: You will receive a
(3x), by German/European health authorities (9x),
qualified answer within two business days. New
by health, safety and environmental agencies (15x)
R&D projects can be started within one week.
and by our customers or their consultants (more
than 80x) up to date. ChemCon never received a
critical observation in company history.
No cross-contamination
Strong communication
The project manager dedicated to your project
will keep you informed. Clear and accurate project
updates, at least once a week, regular telecons
ChemCon is the world´s only manufacturer using
and face-to-face meetings are our standard. Team
dedicated equipment from manufacturing for
ChemCon is easily contacted and quick responding.
clinical phases to commercial production. This
strategy rules out any cross-contamination and is
especially appreciated by regulatory authorities.
Strong regulatory support
People
Our experienced team of scientists will deliver your
products on time, on budget and in top quality.
Over 90% of our chemists are qualified to PhD
ChemCon delivers comprehensive development
level. They have acquired considerable experience
reports for process/method development, all
in in a broad variety of chemical reactions, handling
necessary GMP documentation, e.g. batch/
of high potent molecules and synthesis as well
cleaning/sampling/labeling records, validation
as purification of small molecules, therapeutic
documentation, release protocols, Certificates
polymers, biomolecules and bioconjugates.
of Analysis and Certificates of Conformity, and
the CMC section of ASMFs and DMFs; all in full
compliance with applicable ICH and FDA guidelines.
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