PLANKSTADT EXPERTS TAKING CARE

Transcription

1 CordenPharma PLANKSTADT EXPERTS TAKING CARE

2 Our History Start of Packaging activities (ICI Pharma) Start of Formulation activities (ICI Pharma) First Pre-approval Inspection by FDA Start of High Containment Manufacturing (AstraZeneca) Acquired by ICIG to become key plant of CordenPharma US

3 cordenpharma PLANKSTADT Strategic CMO Partner Highly Potent Solid Dosage Forms CordenPharma Plankstadt is your strategic partner in the development and manufacturing of highly potent solid dosage forms for global markets. Located near Heidelberg, Germany, our state-of-theart containment unit is physically segregated from other manufacturing areas. Full containment is achieved by means of technology, thereby avoiding the need for personal protective equipment. Our units are suitable for batch sizes between 80 and 150 kg, and are validated to handle compounds with an OEL of 1µg/m³/8h (G3b, SafeBridge Category 3). Products with an OEL <1µg/m³/8h (G4) can also be evaluated based on their specific characteristics. As your partner, we work with you to develop highly potent products - spanning all development phases from early feasibility to phase III clinical supplies for seamless transfer to commercial scale, all at the same site. Compliance Worldwide EMA FDA PMDA TGA Health Canada ANVISA

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7 what we do Development & Scale-up Commercial Manufacturing CordenPharma Plankstadt is an internationally approved expert in formulation development, contract manufacturing and packaging of solid dosage forms, with specific experience in the development and manufacturing of oral dosage forms with highly potent compounds. As a full-service CMO for the global market we are committed to being fast, flexible, innovative and reliable. Our global expertise and familiarity with the specific quality standards needed for manufacturing in Europe, the USA, Brazil, and Japan make us your ideal partner for your new and existing products. Core Capabilities Technologies Direct compression Fluid bed granulation High shear granulation Tableting Tablet film-coating Encapsulation Focused Project Management CordenPharma Plankstadt s dedicated project managers with their project teams ensure consistent coordination, communication and alignment of progress throughout all phases of each project. A project manager is assigned at the start of the project to be your direct interface for all project activities from the kick-off meeting to successful implementation of your product. We take care to ensure that project objectives are defined and deliverables are detailed in a mutually-signed project specification document. Technical risks are identified, evaluated and mitigated on a continuous basis and the agreed mitigations are reported throughout the project. Updated project plans are generated and tracked vigorously to ensure that we will always deliver the highest quality to our customers within agreed-upon timelines. CordenPharma Plankstadt is your expert for highly potent solid dosage forms. We offer flexible, cost-effective pharmaceutical development and custom manufacturing services for global markets.

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11 SERVICES With extensive experience in the development and optimization of formulations and processes for phase I - III clinical studies and commercial production, CordenPharma Plankstadt offers a comprehensive range of services in the area of pharmaceutical development comprising: Development and Scale-up of Solid Dosage Forms: Tablets Film-coated tablets (immediate release and modified release) Two-layer tablets Hard capsules Granules or powders for oral suspension/oral solution in single dosage units Analytical Development Services: Physical-chemical characterisation of drug substance Compatibility testing with excipients and investigation of drug-drug interactions QC release testing for clinical supplies Full support for stability studies according to ICH Q1A for all climate conditions Dissolution screening during formulation development, including testing in bio-relevant dissolution media (FaSSIF, FeSSIF) Development and justification of discriminating dissolution methods for IMPD/IND and MA/NDA Transfer, development, and validation of analytical methods for excipients, drug substances and drug products including microbiological methods (TAMC/TYMC/E.coli) acc. to Ph.Eur. for all solid dosage forms DEVELOPMENT Our team of experts takes care to develop your product from technical feasibility to phase III supplies. Your pharmaceutical development projects will benefit from our state-of-the-art technologies and extensive experience in formulation development and manufacturing of clinical supplies for highly potent pharmaceutical compounds with clearly defined OELs (e.g. hormones, hormone blockers, oncological compounds). All standard dosage forms can be developed in a scale of <100 g and scaled-up into pilot scale. Our development approach follows QbD principles from the start for all of our projects, while we tailor the extent of tools used for each development phase based on project needs and customer requirements. Thereby, we balance the benefits and costs of an integrated QbD approach to maximise the quality of our development projects, within the agreed budgets and time-frame. Feasibility testing and development of solid dosage forms are carried out in 3 separated cgmp suites, approved by global health authorities for manufacturing of clinical supplies. One of these cgmp suites is completely separated and validated for manufacturing of highly potent products with OELs <1µg/m 3 /8h, using personal protective equipment. DEVELOPMENT EQUIPMENT Direct Compression: lab blender for L and bin blender for 2 50 L High Shear Granulation: Diosna (bottom drive) granulator for kg and Henschel (bottom drive) granulator for 3-5 kg Fluid Bed Granulation: Glatt WSG (top spray) for 3-5 kg, Aeromatic Strea 1 (top spray and Wurster) for kg, Unilab 05 (tangential spray) for kg, Niro MP1 (top spray and bottom spray) for up to 7 kg Sieving: Erweka oscillating sieve, Quadro Comil centrifugal sieve, Alexanderwerk wet mill Tableting Press: Fette Exacta 1 (single punch) excenter-press and Korsch Pharmapress 230 rotary tablet press (with EURO B & D tooling) Tablet Film-coating (aqueous processes for immediate and modified release coating): Glatt GC 500 for up to 5 kg and Mini Coater Glatt for up to 2 kg tablets Multiparticulate Film-coating (aqueous processes for immediate and modified release coating): Unilab 05 (tangential spray) for kg, Niro MP1 (top spray and bottom spray) for up to 7 kg Hard Capsules: 3 Profill 3007 semi-automatic capsule fillers (for capsule size 000, 00, 0, 1, 3) and Bosch GKF 130 equipped with 100% weight check (for capsule size 00, 0, 1, 2, 3, 4, DBA, DBB)

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15 COMMERCIAL PRODUCTION CordenPharma Plankstadt has well-known expertise and extensive capabilities in the manufacturing of solid oral dosage products, the production of highvolume non-potent tablets and capsules (a standard plant), and the manufacturing of pharmaceutical drug products with highly potent compounds (a containment plant). Our close cooperation between development and production ensures a smooth technology transfer during scale-up, customer transfer, process validation and routine manufacturing. Fully-Contained Plant Our fully-contained plant is validated to handle compounds with an OEB of 1µg/m³/8 hours, and is suitable for batch sizes between 80 and 150 kg, depending on product characteristics. Technologies include: Direct Compression: Kemutec Cone Mill CM220, Matcon Bin Blender 500 l Dry Granulation Fluid Bed Granulation: Glatt WSG 120 High Shear Granulation: Collette Gral 400 (top drive) High Speed Tableting: 2 IMA Comprima 3002 (specialised powder feeding implemented to minimise risk of segregation of powders) Tablet Film-coating: 2 Glatt GC 1250 Coater (for aqueous processes of immediate release and modified release coating) Plant for Highly Potent Products Our dedicated small plant for handling of highly potent pharmaceutical products (e.g. hormones, hormone blockers, oncological compounds) with clearly defined OEL levels has been validated down to 1µg/m³/8h, and is suitable for batch sizes between 40 and 150 kg, depending on product characteristics. In this plant organic solvents can be handled for high shear granulation and fluid bed granulation processes. Technologies include: Direct Compression: Engelsmann bin blender CM320 Dry Granulation High Shear Granulation: Diosna P250 (bottom drive) Fluid Bed Granulation: Aeromatic S5 (equipped with top spray granulation) Tableting: Fette 2090 (with EURO B & D toling) Tablet Film-coating: 48 " Accela Manesty Coater (for aqueous processes of immediate release and modified release coating) Non-potent Product Plant Our standard, non-potent product plant for the manufacturing of large-scale batches is suitable for batch sizes between 120 and 600 kg, depending on product characteristics. Technologies include: Direct Compression: Kemutec Cone Mill U20, Engelsmann bin blender CM1000 Dry Granulation High Shear Granulation: 2 Collette Gral 600 (top drive), 2 Kemutec Cone Mills U20 / U30, 2 Aeromatic T7 dryers Tableting on 6 rotary presses: - Fette 2090i Rotor EU1" Fette Fette 3002 for two-layer tablets - Kilian RX55 for two-layer tablets Tablet Film-coating: 60 " Accela Manesty Coater (for aqueous processes of immediate release and modified release coating) Hard Capsules: 2 Bosch GKF 1500 (equipped with IMA Precisa % weight check) for filling of combination capsules with tablets, granules and powders PACKAGING CordenPharma Plankstadt is an industry-recognised partner in supplying primary and secondary packaging of solid dosage forms. With our 9 validated blister lines, we have the capability for primary packaging of highly potent compounds up to OEB 3A and film-coated compounds up to OEB 4. Our plant is designed to support packaging operations from early-stage feasibility to commercial supplies, offering you a wide range of packaging solutions, packaging material and safety features that will secure your product quality. See our Packaging Brochure for more information.

16 CordenPharma Plankstadt Otto-Hahn-Strasse Plankstadt Germany Phone Fax