C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to

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1 C 5 chemical development contract research custom synthesis cgmp API manufacturing commercial production Welcome to ChemCon

2 Company profile Company profile ChemCon offers outstanding chemical services for customers all over the world. The company is a leading manufacturer of fine chemicals and small to medium scale APIs used in all clinical stages as well as for commercial use. Today, more than 60 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 : The two founders complete their PhDs in the field of bio-inorganic chemistry combined with peptide synthesis and rare analytical methods which provides a broad and in-depth scientific background. 1997: ChemCon is founded and starts offering customer-oriented chemical services in Freiburg, Germany. 1998: The first clean room enters service; the first multi-kilogram API synthesis campaign starts under full GMP compliance. 1999: The first development laboratory enters service and R&D services can now be offered. 2000: ChemCon s first FDA inspection and facility approval (no deficiency). ChemCon becomes Germany s youngest company to receive this proof of highest quality. The project, for which this inspection took place, receives the fastest NDA approval for an anti-cancer treatment in FDA history, achieved together with ChemCon s customer. This demonstrates the high speed of our services. 2001: The first analytical equipment (MP and FT-IR) enters service; ChemCon starts offering broad analytical services. 2003: ChemCon starts in-house education, and develops its own well-educated scientists and chemical professionals following certification for apprenticing. 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 issues within small to medium scale API production. Also, ChemCon receives ISO 9001 certification 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. ChemCon offers the whole range of drug development. Highest Quality In Small Volumes

3 Customer services Customer services ChemCon offers a combination of contract research and custom synthesis with integrated custom manufacturing. Our emphasis is on chemical development and the manufacturing of small organic and inorganic molecules in the field of active 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. 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 specification and cost-effectively. 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.

4 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 manufacturing. Our flexible service portfolio provides innovative organic and inorganic chemical solutions to support timely and efficient chemical development with improved cost efficiency. ChemCon s expertise and services include: literature research route scouting and optimization establishment of analytical methods scale-up from mg to kg You get: full intellectual property synthesis know-how analytical method development technical grade APIs for: - in vitro testing - toxicity studies - formulation development - impurity profile determination

5 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: manufacturing of small volumes in different clean rooms creation of all necessary documents CMC section support analytical validation stability studies You get: precise GMP documentation analytical release packages products for in vivo testing for all clinical phases stability data

6 Commercial chemical and API production Commercial chemical and API production Utilizing our long term know-how and advanced technologies we have all the capabilities required to manufacture fine chemicals and high quality APIs. All our API batches bear a certificate of compliance and are manufactured following cgmp regulations according to ICH Q7 guidelines. Furthermore we offer high containment operations for the manufacturing of cytotoxic and other highly potent APIs. ChemCon manufactures valuable chemicals of high purity on demand, capitalizing on our experience in complex multi-step synthesis of APIs. Our core strengths in this field are: process validation routine production up to hundreds of kg in-house regulatory support handling of controlled substances / HPAPI supply clean rooms to manufacture injectable, ophthalmic, oral or topic grade APIs You get: routine API supply in small to medium scale orphan disease APIs highly potent APIs controlled substances

7 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 formulations we are able to offer the full range in drug development. ChemCon offers the following services for finished dosage forms intended for clinical trials or commercial supply for its active pharmaceutical ingredients (APIs): stability studies development in cooperation with partners release of finished dosage forms manufacturing of placebos You get: drug product manufacturing in small batches for clinical trials

8 Quality control Quality control ChemCon ensures the full scale quality control of your project. Quality control is performed on all stages of the process: and test equipment used for QC is fully qualified for cgmp with DQ-IQ-OQ-PQ. 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 our analytical Analytical equipment: NMR: 400 MHz, multinuclear; HPLC: DAD, UV, RI, ELS detectors; GPC; LC-MS; GC: liquid injection and headspace units, NPD, ALS, 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, identification of pathogens and endotoxin level determination. You get: method development and optimization validation of analytical methods release packages for certification identity, quantitative and limit tests reference standard qualification impurity profiles ICH compliant stability studies

9 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 our processes and increase the efficiency 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. 3 x by US FDA (2000, 2007, 2011) 5 x by German (European) health authorities (2003, 2006, 2008, 2011, 2013) 15 x by health, safety and environmental agencies approx. 100 x by customers ChemCon is ISO 9001:2008 certified

10 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-of-the-art equipment and currently have over 25 fume hoods available for R&D and production support activities. This excellent infrastructure ensures an efficient project realization. Our chromatography services provide an invaluable resource for producing early-stage material without recourse to excessive development time or costs. 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 elevated temperatures. Our purification capabilities applying chromatography or distillation allow an efficient synthesis of your compounds. various sized reactors up to 250 l pressure reactors up to 100 bar temperature range 60 C to C freeze dryers FDA inspected clean room facilities Class C + D distillation equipment milling equipment centrifuges parallel synthesis equipment chromatographic separation equipment

11 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 60 APIs for all phases of drug development, including around 20 commercial APIs, since inception. Quality: more than 100 different inspections and audits successfully passed We have passed more than 100 different inspections and audits in our history. We have never received a critical observation in the company s history. We are ISO 9001 certified and we perform work to GMP, 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

12 Contact Please contact ChemCon for your custom synthesis demands. We will give your project the highest priority and personal attention: ChemCon GmbH Engesserstr. 4b Freiburg, Germany Phone: +49 (0) Fax: +49 (0) Find us on: