Coriolis Pharma · Coriolis Pharma is an independent service provider for formulation research and...
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Science driven formulation development for biopharmaceuticals Coriolis Pharma Biopharmaceutical Research and Development Service www.coriolis-pharma.com Corporate overview Coriolis Pharma is an independent service provider for formulation research and development of biopharmaceutical drugs such as proteins, peptides, monoclonal antibodies, nucleic acids and vaccines. As a fully privately owned company we serve a global client base consisting of both small and large biopharmaceutical companies with molecules in early and late stage development. An interdisciplinary team of highly qualified scientists with many years of experience in formulation development of biopharmaceuticals is supported by an expert scientific advisory board of leading academic researchers in the field. This structure allows Coriolis Pharma to deliver cutting edge service and know-how related to the formulation development of liquid and lyophilized products to the biopharmaceutical industries. In addition to the core formulation capabilities, Coriolis Pharma is also specialized in the field of subvisible particle analysis and characterization of protein aggregates. This includes utilization of the latest innovative technologies such as resonant mass measurements (Archimedes), Nanoparticle Tracking Analysis (Nanosight), Micro-Flow Imaging (MFI), asymmetric and hollow fiber flow field flow fractionation (AF4/HF5), as well as provision of cGMP compliant analytics for selected particle measurement and aggregation characterization methods.
Transcript of Coriolis Pharma · Coriolis Pharma is an independent service provider for formulation research and...
Science driven formulation development for biopharmaceuticals
Coriolis PharmaBiopharmaceutical Research and Development Service
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Corporate overviewCoriolis Pharma is an independent service provider for formulation research and development of biopharmaceutical drugs such as proteins, peptides, monoclonal antibodies, nucleic acids and vaccines. As a fully privately owned company we serve a global client base consisting of both small and large biopharmaceutical companies with molecules in early and late stage development.
An interdisciplinary team of highly qualified scientists with many years of experience in formulation development of bio pharma ceuticals is supported by an expert scientific advisory board of leading academic researchers in the field. This structure allows Coriolis Pharma to deliver cutting edge service and know-how related to the formulation develop ment of liquid and lyophilized products to the biopharmaceutical industries.
In addition to the core formulation capabilities, Coriolis Pharma is also specialized in the field of subvisible particle analysis and characterization of protein aggregates. This includes utilization of the latest innovative technologies such as resonant mass measurements (Archimedes), Nanoparticle Tracking Analysis (Nanosight), Micro-Flow Imaging (MFI), asymmetric and hollow fiber flow field flow fractionation (AF4/HF5), as well as provision of cGMP compliant analytics for selected particle measurement and aggregation characterization methods.
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Formulation is more than just adding excipients to your molecule. It is crucial to challenge the formulations by relevant (stress) conditions and to select the best set of stability indicating analytical techniques that guide you to an optimum and robust formulation.
A robust formulation will protect your molecule until it is finally administered to the patient from the numerous stress factors it will encounter during production, storage, shipment, sampling handling and application to the patient. We support your container closure selection by testing for possible instability and/or incompatibility of your protein with common primary packaging materials. Finally, the compatibility with the clinical setting will be shown.
Our philosophy: combining science, customer orientation and good research practice
The strong scientific orientation of Coriolis Pharma in the field of protein and vaccine formulation, as well as aggregation and particle analytics has led to numerous recognized key publications in the field of formulation science. This may appear uncommon for a contract research organization but in combination with a dedicated customer orientation and application of good research practice this perfectly meets our philosophy of ensuring both customer and scientific excellence.
Pre-formulation screening
• Identifying suitable formulation composition with respect to pH, ionic strength, protein concentration, excipients• Excipient screening• High throughput formulation approach and DoE possible• Identification of degradation products and elucidation of degradation pathways• Development and selection of stability indicating methods
Development of liquid and dried formulations (lyophilized, spray-dried and spray-freeze-dried) for all phases of development
• Pre-clinical formulation development, e.g. liquid, frozen or dried formulations for Tox-studies• Formulations for early clinical development, e.g. liquid or dried formulations for clinical Phase I, IIa and IIb• Formulations for late clinical development (Phase III) and commercial application
Coriolis Pharma
Biopharmaceutical Research and Development Service
Fraunhoferstraße 18 b | 82152 Martinsried | Germany
Phone +49 (0) 89 – 41 77 60-0Fax +49 (0) 89 – 41 77 60-222
www.coriolis-pharma.com
Science driven formulation development for biopharmaceuticals
Further formulation services
• Formulation optimization or reformulation studies• Testing compatibility with the clinical settings• Container closure selection• Investigations on drug-container compatibility, e.g. protein adsorption or stability in the presence of silicone oil• Answering scientific questions, e.g. asked by the authorities on degradation pathways, aggregation mechanisms and kinetics• Trouble shooting, e.g. manufacturing-related problems
