TOGETHER WE CURE
At Akron Biotech , we manufacture ancillary materials and provide specialized services to accelerate the development and commercialization of advanced therapies 2
Industry Leadership INDUSTRY PRESENCE Board of ARM Foundation, CCRM, Standards Coordinating Body (SCB), ISCT Strategic Advisory Council Work with FDA, ISO, NAS (Forum on Regenerative Medicine), SCB, and others to foster standardization INNOVATION AT AKRON Several patented and patent-pending technologies, including: non-DMSO preservation and cryopreservation solutions, recombinant protein formulations, engineered tissue products COMMITMENT TO QUALITY ISO 13485 compliant Quality Management System (QMS) Products manufactured, tested, and released following cGMP guidelines 3 3
Our Capabilities Proteins and Media Recombinant Cytokines Cryopreservation Media and Growth Factors Supplements Contract Development and Manufacturing Services 4
RECOMBINANT CYTOKINES AND GROWTH FACTORS 5 CONFIDENTIAL NOT FOR FURTHER DISTRIBUTION
cGMP Cytokines EXPERIENCE IN RECOMBINANT PROTEIN DEVELOPMENT DATES BACK TO 1989 · Broad range of biosimilars registered from 1991 onward · Manufacturing IL-2 since 1996 PRODUCED UNDER CGMP FOR RESEARCH AND FURTHER MANUFACTURING USE: · Interleukins and beyond: IL-2 (lyophilized/liquid, 24-month stability), IL-7, IL-15, IL-21, EGF, EPO, SCF, and many more SUPPORTING CLINICAL AND COMMERCIAL SUCCESS OF ADVANCED THERAPIES: · eCTD Drug Master File (DMF) for IL-2 (IL-7, IL-15 & IL-21 soon) · In-house sterile fjltration (0.2 µm), lyophilization, and fjlling · Large scale (gram) production capacity to ensure security of supply · Purifjed through pharmaceutical processes (SEC/TFF) 6
Growing Portfolio of cGMP Cytokines Product Source Cat# rHu bFGF E. coli AK9784 rHu EGF E. coli AK9797 rHu EPO CHO AK9941 rHu G-CSF E. coli AK8248 rHu GM-CSF E. coli AK8341 rHu PEG-GCSF E. coli AK9032 rHu IFN alpha 2a E. coli AK8561 rHu IFN alpha 2b E. coli AK8237 rHu IGF-1 E. coli AK9901 rHu IL-2 E. coli AK8223 rHu IL-2 (pre-fjlled syringe) E. coli AK9984 rHu IL-2 , 22 MIU AR1002 rHu IL-3 Yeast AK9836 rHu IL-4 Yeast AK9839 rHu IL-6 E. coli AK9841 rHu IL-7 E. coli AK9842 rHu IL-12 Yeast AK9995 rHu IL-15 E. coli AK9823 rHu IL-18 Yeast AK9999 rHu IL-21 E. coli AK9833 rHu Insulin Yeast AK9844 rHu PDGF-BB Yeast AK8274 rHu PDGF-AA Yeast AK9711 rHu SCF Yeast AK9879 rHu TGF beta 1 CHO AR1009 rHu TNF alpha Yeast AK9887 rHu VEGF CHO AK9063 7
CRYOPRESERVATION SOLUTIONS: DMSO AND DMSO-FREE 8 CONFIDENTIAL NOT FOR FURTHER DISTRIBUTION
CryoNovo DMSO-Free Cryopreservation Solutions Ready-to-use solutions DMSO-free Serum-free Animal component-free Manufactured under ISO 13485 guidelines Packaging options: vials, bottles, syringes & bags 9
CryoNovo A19 DMSO-Free Cryopreservation Medium Manufactured under cGMP with supporting documentation and validation of processes Animal Studies underway to ensure the absence of local and systemic toxicity Evaluated with various cell types: Optimized for cryopreservation of MSCs as well as multicellular tissues Release testing validations to be completed shortly, stability program to begin by end of 2019 eCTD DMF preparation underway , to be submitted by end of 2019 DoD SBIR Phase I/II and ARMI Grants awarded to support progress 10
CONFIDENTIAL NOT FOR FURTHER DISTRIBUTION PROTEINS AND MEDIA SUPPLEMENTS 11
Human Derived Products HSA, AB Serum, Fibronectin, Vitronectin, and Beyond Manufactured under cGMP conditions in a licensed facility, DMF available (HSA) Donors are traceable to the US; plasma units collected in FDA-registered facilities Formulated with WFI (water for injection) Do not contain additives/preservatives High purity, low endotoxin Donor plasma units viral tested as per 21 CFR 610.40 Custom packaging available such as vials, bags, syringes Custom testing and gamma irradiation available upon request 12
CONTRACT DEVELOPMENT AND MANUFACTURING SERVICES 13 CONFIDENTIAL NOT FOR FURTHER DISTRIBUTION
Contract Protein Development and Manufacturing Both microbial and mammalian cell derived recombinant proteins, including pegylation Protein production from laboratory to commercial scale in 200L single-use bioreactors Several high-throughput tools for development, processing, and analysis of purifjed recombinant proteins Purifjed proteins can be delivered in either a liquid solution or as a shelf-stable lyophilized powder All fjnal products are processed in line with cGMP requirements to guarantee purity, quality, and consistency 14
Custom Media Development and Manufacturing CUSTOM MEDIA DEVELOPMENT, FORMULATION, AND TESTING Component sourcing – including supplier qualifjcation Raw material testing (i.e. endotoxin) and screening Comprehensive testing of fjnal formulation LARGE SCALE CONTRACT MEDIA MANUFACTURING (POWDER OR LIQUID) 30 – 500L production runs cGMP manufacturing Comprehensive testing services Development and engineering runs Aseptic fjll in customized aliquots and packaging 15
Plasmid DNA Manufacturing Sequence and synthesize genes Clone genes into plasmid vectors Generate master and working cell banks Plasmid DNA produced under cGMPs Large scale production capacity (g) in single-use systems Documentation and support for regulatory fjlings 16
Bioengineered Scaffold Development & Fabrication Aligned Random Axially Aligned Tubular Grided ANALYTICAL CAPABILITIES TECHNIQUES MANUFACTURING CAPABILITIES · Scanning Electron Microscopy (SEM) · Emulsion Electrospinning · Lyophilization · Atomic Force Microscopy (AFM) · Co-axial Electrospinning · Cryomilling · UV-Vis Spectrophotometry/ELISA · Post-Electrospinning Surface · Surface modifjcations including · X-ray Photoelectron Spectroscopy (XPS) Modifjcation Plasma Treatment · Fluorescence Microscopy · Sacrifjcial Fiber Electrospinning · Immobilization of Biologicals 17
Commercial Contract Manufacturing Class ISO 7/5 cleanrooms for contract manufacturing PICS certifjcation ICH guidelines Regulatory submissions Full qualifjcation, validation, and documentation Release and stability testing 18
Aseptic Fill & Finish 1. Identify critical components, perform a risk assessment, and fjnd primary and secondary sources for critical components 2. Qualify and source raw materials from client’s approved suppliers/Akron approved suppliers 3. Transfer technology of any prior work completed on formulation or manufacturing processes 4. Complete aseptic media fjll, development runs, and engineering/validation run to validate your sterile-fjll claim 5. Set manufacturing process/specifjcations and fjnal product specifjcations based on consistent and repeatable data 6. Formulate & fjll in custom, single-use, and closed packaging 7. Set-up accelerated or concurrent stability studies to validate sterility claims in new packaging 8. Provide documentation and support for regulatory fjlings 19
Phone: +1.561.750.6120 Website: www.akronbiotech.com Email: info@akronbiotech.com Sales Department: sales@akronbiotech.com Technical Support: techsupport@akronbiotech.com Customer Service: support@akronbiotech.com 20
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