Welcome to the ChemCon Company Presentation: 6 Steps to...

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Welcome to the ChemCon Company Presentation: 6 Steps to Success for our Customers!

Transcript of Welcome to the ChemCon Company Presentation: 6 Steps to...

Page 1: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

Welcome to the ChemCon

Company Presentation:

6 Steps to Success

for our Customers!

Page 2: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 3: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 4: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

ChemCon´s unique combination of Chemical Services today:

Page 5: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

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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

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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

Page 8: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 9: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 10: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 11: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 12: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 13: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 14: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 15: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

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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

Page 17: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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!

Page 18: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 19: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 20: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

ChemCon´s Projects and Indications

Page 21: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

ChemCons broad experience: Find your desired class of compound or reaction type!

Page 22: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 23: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 24: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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

Page 25: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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!

Page 26: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

Summary

Team ChemCon says „Thank you!“

Page 27: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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.

Page 28: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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)

Page 29: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

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.

Page 30: Welcome to the ChemCon Company Presentation: 6 Steps to ...Partnering_Veranstaltung/11+ChemCon-p-1… · 1997: ChemCon was founded as a Chem ical Con sulting Company. ChemCon´s Start

6 Steps to Success for our Customers!

Step 1:

Contact ChemCon

Step 2:

Process develop-ment

Step 3:

Pilot scale manu-facturing

Step 4:

API manu-facturing

Step 6:

Release of APIs

Step 5:

Analytics