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16400 Bubbling Wells Rd., 284 Desert Hot Springs , CA, 92240 United StatesLONGMORE 60 BIOTECH INC. is an international consultancy specialized on the development of Biopharmaceuticals from cloning to filing. We offer full-service support for all activities involved in the development, manufacturing, clinical development (including a full-service CRO) and approval (FDA, EMA, Health Canada, ANVISA, TGA etc.) of Biopharmaceutical Assets including but not limited to Biologics, Biosimilars and Bio-betters. For your international activities we offer a technical/scientific translation service as well a representation in the USA, Canada, Brasil, Latam and EU. Scope of Services • PROCESS DEVELOPMENT, SCALE UP, MANUFACTURING Longmore 60 Biotech have hands-on experience in the development of glycosylated and non- glycosylated therapeutic proteins, fusion proteins, conjugates and monoclonal antibodies. Based on our previous experience with expression systems which included plant (moss, tobacco), E-coli, yeast, hybridoma, SP2/0, CHO and others, we command state-of-the-art technologies. We select, direct and supervise your third-party cell line development. Activities supervised include cloning, lead clone selection, media, process optimization followed by testing and generation of the GMP Master and Working Cell Banks. We strive to achieve the optimal balance between yield, key quality criteria and cell line properties. Our up-stream processing and manufacturing experience encompasses fed-batch, tangential flow yield enhancement technologies (e.g. ATF, XD) and perfusion utilizing ATF, spin-filters, ultrasound, etc. Set up of relevant analytical, bioanalytical methods, bioassays and the product specific downstream processing and fill & finish. Vendor selection, timelines, project management, vendor management and budget planning and control. Planning, organization, management and supervision of international multi-party tech- transfer activities. Due-diligence, gap-analyses, trouble shooting for all of the above rounds off our comprehensive service package. • BIOPHARMACEUTICAL FACILITY PLANNING and SET-UP (non-GMP, GMP-pilot plants, manufacturing plants) Planning, set-up, vendor selection, full supervision, management, GMP, local regulations, due-diligence, GMP-inspections and pre-approval inspections and many other activities surrounding Biopharmaceutical facilities. We will support or fully direct the decision management involved in USP and DSP Equipment/Vendor selection, including supervision and timing of the installation. We will ensure that the necessary elements and infrastructure are installed, functional, operational and validated. • CLINICAL DEVELOPMENT Longmore 60 has planned, implemented and directed many full clinical programs (Phases I – III) for Biopharmaceuticals, Biosimilars and Bio-betters. Therapeutic areas covered were: Oncology (e.g. RCC, Breast Cancer, Colorectal Cancer, NHL, etc.), Hematology (e.g. Hemodialysis management), Auto-Immune Diseases (e.g. RA, Psoriasis, Ulcerative Colitis, Morbus Crohn), Neurology (e.g. Multiple Sclerosis), Infectious Diseases (Bacterial Infections) and more. Clinical due-diligence, trouble shooting, gap-analyses, vendor selection/management, budget planning/supervision, quality control, tracking. • REGULATORY AFFAIRS International Regulatory strategies (EU, USA, Canada, Australia, Japan, Brazil, etc.). Planning, set-up, preparation and management of regulatory meetings with FDA, EMA, Health Canada, ANVISA, TGA, PMDA and others. Regulatory Due-Diligence. Document review, Gap-analyses. Direction of regulatory meetings, preparation and rehearsals. 3. Regulatory/Scientific and Technical Support In order to round off the above service portfolio, Longmore 60 offers Translation, Representation, Implementation and Coaching. - Translations: English/German/Spanish/Portuguese - Technical Writing - Rehearsal + Coaching - Due-diligence, Inspections, Preparatory meetings, Reviews Including but not limited to.... o Scientific documentation e.g. briefing documents, regulatory reports, expert reports, dossiers, clinical protocols, case report forms, insert leaflets, SOP’s o Regulatory representation and interaction: e.g. FDA, EMA, ANVISA ▪ Meeting set-up ▪ Project management o Presentations – regulatory, conferences, marketing, fund raising, investigator meetings
11821 Wallflower Court Adelanto, CA, 92301 United StatesLONGMORE 60 BIOTECH INC. is an international consultancy specialized on the development of Biopharmaceuticals from cloning to filing. We offer full-service support for all activities involved in the development, manufacturing, clinical development (including a full-service CRO) and approval (FDA, EMA, Health Canada, ANVISA, TGA etc.) of Biopharmaceutical Assets including but not limited to Biologics, Biosimilars and Bio-betters. For your international activities we offer a technical/scientific translation service as well a representation in the USA, Canada, Brasil, Latam and EU. Scope of Services • PROCESS DEVELOPMENT, SCALE UP, MANUFACTURING Longmore 60 Biotech have hands-on experience in the development of glycosylated and non- glycosylated therapeutic proteins, fusion proteins, conjugates and monoclonal antibodies. Based on our previous experience with expression systems which included plant (moss, tobacco), E-coli, yeast, hybridoma, SP2/0, CHO and others, we command state-of-the-art technologies. We select, direct and supervise your third-party cell line development. Activities supervised include cloning, lead clone selection, media, process optimization followed by testing and generation of the GMP Master and Working Cell Banks. We strive to achieve the optimal balance between yield, key quality criteria and cell line properties. Our up-stream processing and manufacturing experience encompasses fed-batch, tangential flow yield enhancement technologies (e.g. ATF, XD) and perfusion utilizing ATF, spin-filters, ultrasound, etc. Set up of relevant analytical, bioanalytical methods, bioassays and the product specific downstream processing and fill & finish. Vendor selection, timelines, project management, vendor management and budget planning and control. Planning, organization, management and supervision of international multi-party tech- transfer activities. Due-diligence, gap-analyses, trouble shooting for all of the above rounds off our comprehensive service package. • BIOPHARMACEUTICAL FACILITY PLANNING and SET-UP (non-GMP, GMP-pilot plants, manufacturing plants) Planning, set-up, vendor selection, full supervision, management, GMP, local regulations, due-diligence, GMP-inspections and pre-approval inspections and many other activities surrounding Biopharmaceutical facilities. We will support or fully direct the decision management involved in USP and DSP Equipment/Vendor selection, including supervision and timing of the installation. We will ensure that the necessary elements and infrastructure are installed, functional, operational and validated. • CLINICAL DEVELOPMENT Longmore 60 has planned, implemented and directed many full clinical programs (Phases I – III) for Biopharmaceuticals, Biosimilars and Bio-betters. Therapeutic areas covered were: Oncology (e.g. RCC, Breast Cancer, Colorectal Cancer, NHL, etc.), Hematology (e.g. Hemodialysis management), Auto-Immune Diseases (e.g. RA, Psoriasis, Ulcerative Colitis, Morbus Crohn), Neurology (e.g. Multiple Sclerosis), Infectious Diseases (Bacterial Infections) and more. Clinical due-diligence, trouble shooting, gap-analyses, vendor selection/management, budget planning/supervision, quality control, tracking. • REGULATORY AFFAIRS International Regulatory strategies (EU, USA, Canada, Australia, Japan, Brazil, etc.). Planning, set-up, preparation and management of regulatory meetings with FDA, EMA, Health Canada, ANVISA, TGA, PMDA and others. Regulatory Due-Diligence. Document review, Gap-analyses. Direction of regulatory meetings, preparation and rehearsals. 3. Regulatory/Scientific and Technical Support In order to round off the above service portfolio, Longmore 60 offers Translation, Representation, Implementation and Coaching. - Translations: English/German/Spanish/Portuguese - Technical Writing - Rehearsal + Coaching - Due-diligence, Inspections, Preparatory meetings, Reviews Including but not limited to.... o Scientific documentation e.g. briefing documents, regulatory reports, expert reports, dossiers, clinical protocols, case report forms, insert leaflets, SOP’s o Regulatory representation and interaction: e.g. FDA, EMA, ANVISA ▪ Meeting set-up ▪ Project management o Presentations – regulatory, conferences, marketing, fund raising, investigator meetings
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