The Founder´s Vision
1992: Dr. Peter Gockel develops synthesis
routes of future Active Pharmaceutical
Ingredients at the University of Freiburg.
1994: The later founders of ChemCon, Dr.
Gockel and Dr. Vogler start their scientific
cooperation in the fields of peptide
synthesis, metal complex research and
stability constant determination in solution.
1996: The Innovative Founder´s Vision is the Manufacturing of new
metal containing Active Pharmaceutical Ingredients
1997: ChemCon was founded as a
Chemical Consulting Company.
ChemCon´s Start
1998: ChemCon turned to be an API
manufacturing company, working under
full cGMP compliance. Characteristics
of the first contract:
- Metal complex of an organic ligand
- Cytostatic substance
- Injectable grade, full microbiological
control in a clean room environment
- Scale: 10 kgs per month
Optionally: Meet ChemCon representatives at the following trade shows:
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Step 1: Draw your molecule,
contact us,
and we will work at your synthesis!
- Elaboration of chemical processes and development of synthetic routes- Implementation of synthetic routes and scale-up of chemical processes
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Step 2: Process development at our state-of-the-art laboratories
- Development and custom synthesis of organic and inorganic chemical specialties and standards
- Handling of high potent, toxic, air / moisture / temperature / light sensitive compounds
- Reaction performance at temperatures between -100°C and 230°C.- Parallel synthesizers for fast process development.
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Step 3: Production of the substance in pilot scalee.g. for later use for preclinical testings
- Scale-up of chemical processes- Custom synthesis of organic and inorganic chemical specialties,
standards, reference material, etc.
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Step 4: Manufacturing of the API at ChemCon´s Clean Room Facilities
- Process transfer from R&D to cGMP including scale-up from mg to kg andprocess validation
- GMP-development for small molecules in pharmaceutics, generics, diagnostics, applicable for all clinical phases up to commercial material
- Commercial API manufacturing in small scale (g to multi kg)
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
ChemConShop Cooperation:
Pilot Plant for the Production of APIs and Intermediates
� Glass Reactors from 1 ml to 450 l(more than 450 reactors < 3l / 150 reactors from 3 l to 70 l, 200 l, 300 l, 2 reactors with 450 l)
� Hastelloy-reactors with 50 l und 350 l� Pressure reactors: 350 ml (10 bar), 2 l and 4 l (40 bar),
10 l (10 bar), 2 l and 20 l (8 bar), 350 l (8 bar)� Pressure filters: 30 l Seitz and 100 l� Vacuum filtration from < 1 ml to 200 l� Centrifuges: 5 kg Hastelloy and 90 kg� Rotational evaporators: 15 x 3 l, 10 l, 4 x 20 l� Chromatografic equipment for large scale chromatography� Lyophilisations with up to 22 kg water in 24 h
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Step 5: Analysis of the product
- Analytic method development including release plan, analytical data sheet, certificate of analysis, analytical reports, analytical validation master plan, method validation plan and report.
- Stability and degradation studies
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Step 6: Release of the final API by our regulatory team
The manufacturing under CGMP includes complete set of documentation liketype II drug master files, master batch / cleaning / labeling records, validation master plans, reports, etc.
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
ChemCons QM-Documentation
As a part of ChemCon´s Quality Control all Products shipped by
us are provided with an Analytical Data Sheet for non-GMP
material and an Certificate of Analysis for GMP material.
All other documents were handed out to the Customers on
request.
Documentation for
a GMP Product
Manufacturing Documents QC Documents
� Batch Record
� Cleaning Record
� Labeling Record
� Release Plan
� Analytical Data Sheet
� Certificate of Analysis
� Analytical Reports
Batch File
� Validation Master Plan
� Process Validation Plan
� Process Validation Report
� Analytical Validation Master Plan
� Method Validation Plan
� Method Validation Report
Step 1:
Contact ChemCon
Step 2:
Process development
Step 3:
Pilot scale manuacturing
Step 4:
API manu-facturing
Step 6:
Release of APIs
Step 5:
Analytics
Finally you hold your product in your hand:- Organic or inorganic chemical specialty- Reference standard, diagnostics, intermediates- API for preclinical use- API under cGMP for all clinical human testing stages- Commercial API including all validation and documentation
Finally: The PRODUCT for our customer!
ChemCon is Germany´s youngest independent API manufacturer, who passed an FDA audit without 483
ChemCon developed the manufacturing process and is thecurrent producer of the cytostatic compound with the fastest NDA-approval in FDA history
ChemCon is an independent, privately held company,which received the BW-L-Bank-Award in 2004 for itsexcellent management and steady economical development
ChemCons Success Story
ChemCon worked for more than 100 customers already. Some examples are listed below:
ChemCon´s Customers
BASF
ChemWerth Helm
Novartis
CEFIC
Sigma-Aldrich Strem Chemicals
University Freiburg University Hospital Freiburg
Sanofi-Aventis
Big Pharma & Chemistry
Roche
Trading Companies
Universities and Research Institutes
Abbott AstraZeneca degussa Quintiles
BiotechnologyCompanies
IBAM Sourcon Padena ATG:biosynthetics
ChemCon´s Scientific Cooperation partners:
Analytic Cooperation Partners:
Scientific Cooperation Partners:
GIU IBAM
CureVac EMC Microcollections Genmedics
KKSUKT MCAT
Sourcon Padena University of Freiburg
ChemShopSiegfried CASID-Members
Manufacturing Cooperation Partners:
IoLiTec
AQura
HELSINN
BioTechCooperation Partners:
Across Barriers ASPIRAS ATG:biosynthetics ProQinase Rentschler
ChemCon is member of the following organizations:
Synthetic Organic Chemical
Manufacturers Association
Gesellschaft Deutscher Chemiker
Parenteral Drug Association
Verband der Chemischen Industrie
BioValley Deutschland e.V.
President: Dr. R. Vogler
Deutsche Industrievereinigung
Biotechnologie
American Chemical Society
Gesellschaft für Chemische
Technik und Biotechnologie e.V.
Berufsgenossenschaft der
chemischen Industrie
Chemische Auftragssynthese
in Deutschland
Drug Discovery Net
Vereinigung deutscher
Biotechnologie-Unternehmen
Scientific Organizations:
Industrial Organizations:
ChemCon was co-founder of:
Responsible
CareIndustrie und
Handelskammer
BioPro Baden
Württemberg
BioRegio Freiburg
Stiftung BioMed
Freiburg
R&D, Development and Manufacturing:
ChemCon GmbH/PartG
Freiburg, BW, Germany
ChemCon´s Locations
Financial Headquarters:
ChemCon GmbH
Ludwigshafen, RP, Germany
R&D, Storage and Shipments:
ChemCon America, Inc.
Orlando, FL, USA
Sales representation:
ChemCon America, Inc.
Detroit, MI, USA
NEW: ChemCon´s Product List
ChemCon offers products of theirown manufacturing and also products from partners:
- APIs for the European market- Specialty chemicals- Biological extracted compounds- Catalysts- Kinases- RNAs and Nucleotides
Ask for the newest product list!
Recent Highlights in 2005/2006
Largest project in ChemCons history:In Jan. 2006, ChemCon received an order for the largest quantity in the companies
history. It requires the manufacturing of 1000 kg of a specialty chemical, to be
delivered in Q1/Q2 in 2006. With this project ChemCon enters a new dimension of scale!
24 new ChemCon customers in 2005:ChemCon acquired 24 new customers in 2005.
ChemCon was able to double the revenue with European customers compared to 2004.
5 large projects were started with US / Canadian customers.
ChemCon America, Inc. moved to new building:ChemCon America, Inc. moved to a new building and established a -80°C storage for
temperature sensitive substances.
Audit by German Health Authorities (Regierungspraesidium Tuebingen):In January, ChemCon was audited by the Regierungspraesidium Tuebingen, the German
Health Authorities, without any observation. We received the permission the release final
dosage forms for human use.
Recent Highlights in 2005/2006
New Advisory Board:ChemCon established an Advisory Board with well known professionals from the
pharmaceutical and chemical Industry as well as from University and Finances:
New large API manufacturing projects:ChemCon has completed 2 more CGMP process validations in Jan. 2006, the launch of
the commercial material will be in Q3 2006.
- Prof. Dr. Vahrenkamp, formerly University of Freiburg (Head of Inorganic Chemistry)
- Prof. Dr. Kleemann, formerly, Degussa / AstaMedica (Head of AstaMedica)
- Dr. Wagner, formerly BASF / Abbott (Head of Abbott Germany)
- Dr. Witzke, formerly Pfizer / Goedecke (Head of R&D and Development Pfizer FR)
- Dr. jur. R. Storz, formerly Bosch (Head of Finances and Taxes)
- Mr. Meyer-Scherling, formerly Rothschild Bank (Head of Merger & Acquisitions)
New Investments in 2005/2006
Parallel Synthesis Equipment: ChemCon invested in parallel synthesis equipment to speed up development projects:
- 24 Microreactors in parallel to be heated up to 200°C
- 16 Microreactors in parallel for room temperature reactions
- 10 Microreactors in parrallel to be cooled down to -50°C
Additional new equipment, invested in 2005 at ChemCon:- 10 new reactors 20l, 3 new reactors 50l
- 2 new evaporators 20l
- 1 new column for 7.5 kgs separation material
- 1 new large destillation apparatus, up to 10 l / h
GMP manufacturing area for oral / topic grade APIs:ChemCon is establishing the 3rd GMP manufacturing area. After 2 clean room facilities
dedicated for injectable grade API manufacturing, a 3rd laboratory dedicated for oral /
topic grade API manufacturing is necessary. ChemCon already worked on 3 oral / topic
API projects.