Welcome to MedScope!
Fac: MedScope offers a full range of rapid global Regulatory, CMC, and Medical consulting services through all phases of cGMP development, both pre and post approval. MedScope has core competencies in Gene Therapy, Monoclonal Antibody Immunotherapy, and Small Molecule Development, both from a CMC and Medical perspective. MedScope is a rapid development organization, and in most instances can initiate value-based discussions within 24 hours.
Process Development & Clinical/Commercial Operations
MedScope is a leader in developing state-of-the-art manufacturing tecchnologies, and we have successfully lead development and launch of numerous QbD products, including continuously manufactured products with integreated PAT feedback and feedforward controls, using both single use and stainless components. Additionally, MedScope has substantial commercialization expertise, and over the years has lead manufacturing development of over 1,000 cGMP batches (inlcuding QbD documentation protocols, BPR, specs, test methods, equipment qualification, reulatory control strategies, technology transfers, equipment acquisition and qualification, PPQ), and completed successful PAI and launch of 9 commercial product lines. MedScope has strong competency in Quality and Regulatory Sciences, and can rapidly aid in development, filing, and interaction with various regulatory bodies worldwide. Additionally, MedScope has over 150,000 ft2 in open manufacturing space that can quickly be converted to ISO7 space for closed cGMP manufacture in partnership with the customer. Last, MedScope has core worldwide capabilities in Medical Affairs and Clinical Development (including Rare Disease, Pediatric Exclusions, Breakthrough Therapies), throughout all stages of development and commercialization. MedScope is also recoginized for core strengths in Medicine, with substantial clinical development experience in rare disease, pediatrics, and breakthrough therapy.
cGMP CDMO Operations
MedScope operates by development phase(pre clinical, IND enabling, clinical development, commercial), by service(process development, analytical, manufacturing CMC, facilities and site audits, regulatory scienes, quality, medcial affairs, sales and marketing, political advocacy, computational biology), and by disease(oncology, immunology, immuno-oncology, infectious disease). MedScope is a fully functional cGMP operation, and can quickly can review and/or implement custom CDMO closed system DOE/Clinical/Manufacturing trials. Please call for further details.
Regulatory Science
MedScope excels at providing rapid, intuitive Regulatory expertise, particulary in the process sciences and in particular in the Lenti/AAV, and Monoclonal Antibody Space (including Biosmilars). Whether you are seeking pre-IND support, Phase II/III Support, Biosimilar Support, MedScope can quickly help develop core cGMP control strategies, Development Reports, etc., as well as strategize regulatory planing in order to balance development and regulatory risk with clinical risk.
Analytical Development/Process Analytics
MedScope can review and/or provide a wide range of comprehensive range of high-quality analytical assays to characterize protein therapeutics. Whether characterizing the original or subsequent reference standards, evaluating production lots to those standards or performing comparability studies of biosimilars or biobetters, we have the full-range of methodologies available to provide the detailed analysis required to pass scientific and worldwide regulatory standards. Areas of supporting expertise include Lenti (Using HEK293T Cells), and AAV Vectors, Viral Clearance/Inactivation, Assay /Bioassay Development, Protein Characterization, and Cell Line Characterization. Technical and regulatory expertise inlcude virology, molecular biology, cell biology, in-life and microbiology labs to provide high-quality and comprehensive CLC services. ICH and NMPA (previously CFDA) guidelines. The methods we work with are harmonized with global standards (e.g. ICH, EP, USP, JP, CN).
Manufacturing and ComOps
MedScope has access to over 150,000 ft2 of fully enclosed enterprise manufacturing open space, and can quickly scale out closes system modules sith SU support to suit your manufacturing needs. This capability is supported by an entire cGMP suite of SOP's, BPR's, Protocols, Training Modules, Equipment Qualification Protocols, and Quality Event Tracking. MedScope also partners with several partners in order to provide a wide range of cGMP test services including Immunoassays(ELISA: high throughput to determine antibody specificity/sensitivity to target antigens), Western Blotting, Multiplexed Bead-based Assays), Stability Indicating Assays(SE-HPLC, IEX-HPLC or cIEF, CE-SDS, and Potency Assays), Chromatography(Protein G, Size Exclusion), etc.
Facilities
MedScope is rapidly scaling -up,-out, state of the art (Continuous, SU, PAT, Closed) cGMP manufacturing facilities for the production of biologics (Lenti, AAV, Monoclonal and Bispecific Antibodies, Fusion Proteins, Monoclonal Antibodies (via either Myeloma-Mouse B Cell, or Lenti-CHO Transfection)). MedScope has a strong biologics facilities expertise, as well as deep experience in FDA Site Inspections.
Quality
MedScope is highly experienced in developing cGMP documentation, including BPR's, Protocols, Forms, SOP's, Qualification Documents, Tech Transfer Reports, etc. More importantly, MedScope has tremendous experience integrating Quality Operations plant-wide with Regulatory, Development, Manufacturing, QC & Analytical, and Sales and Marketing. MedScope can also provide site regulatory/quality audits, facilities inspections, audit pre-approval inspections (PAI), as well as new cGMP equipment (both test and manufacturing) acquisition and qualification.
Sales & Marketing
Politcal Advocacy
MedScope is an active political advocate integrating the many new medical technologies with political advocacy groups.
Computational Nucleotide/Polypeptide Modelling
How To Reach Us
MedScope is a rapid development organization, and in most instances can initiate and address a wide range of value-based discussions within 24 hours. Our teams and wide technological network in the biopharmaceutical industry enables us to quickly bring substantial knowledge and problem solving skills to help you quickly solve problems. For rapid response, please contact us at 802-236-8650 or info@medscope.com.
