TOGETHER WE CURE

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At Akron Biotech, we manufacture ancillary

materials and provide specialized services to

accelerate the development and commercialization of

advanced therapies

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INNOVATION AT AKRONSeveral patented and patent-pending technologies, including: non-DMSO preservation and cryopreservation solutions, recombinant protein formulations, engineered tissue products

COMMITMENT TO QUALITYISO 13485 compliant Quality Management System (QMS)

Products manufactured, tested, and released following cGMP guidelines

INDUSTRY PRESENCEBoard 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

Industry Leadership

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Recombinant Cytokines and Growth FactorsCryopreservation Media

Contract Development and Manufacturing Services

Proteins and Media Supplements

Our Capabilities

5CONFIDENTIAL NOT FOR FURTHER DISTRIBUTION

RECOMBINANT CYTOKINES AND GROWTH FACTORS

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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 filtration (0.2 µm), lyophilization, and filling · Large scale (gram) production capacity to ensure security of supply· Purified through pharmaceutical processes (SEC/TFF)

cGMP Cytokines

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Product Source Cat#rHu bFGF E. coli AK9784rHu EGF E. coli AK9797rHu EPO CHO AK9941rHu G-CSF E. coli AK8248rHu GM-CSF E. coli AK8341rHu PEG-GCSF E. coli AK9032rHu IFN alpha 2a E. coli AK8561rHu IFN alpha 2b E. coli AK8237rHu IGF-1 E. coli AK9901rHu IL-2 E. coli AK8223rHu IL-2 (pre-filled syringe) E. coli AK9984rHu IL-2 , 22 MIU AR1002rHu IL-3 Yeast AK9836rHu IL-4 Yeast AK9839rHu IL-6 E. coli AK9841rHu IL-7 E. coli AK9842rHu IL-12 Yeast AK9995rHu IL-15 E. coli AK9823 rHu IL-18 Yeast AK9999rHu IL-21 E. coli AK9833rHu Insulin Yeast AK9844rHu PDGF-BB Yeast AK8274rHu PDGF-AA Yeast AK9711rHu SCF Yeast AK9879rHu TGF beta 1 CHO AR1009rHu TNF alpha Yeast AK9887 rHu VEGF CHO AK9063

Growing Portfolio of cGMP Cytokines

8CONFIDENTIAL NOT FOR FURTHER DISTRIBUTION

CRYOPRESERVATION SOLUTIONS: DMSO AND DMSO-FREE

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Ready-to-use solutions

DMSO-free

Serum-free

Animal component-free

Manufactured under ISO 13485 guidelines

Packaging options: vials, bottles, syringes & bags

CryoNovo DMSO-Free Cryopreservation Solutions

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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

CryoNovo A19 DMSO-Free Cryopreservation Medium

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PROTEINS AND MEDIA SUPPLEMENTS

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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

Human Derived ProductsHSA, AB Serum, Fibronectin, Vitronectin, and Beyond

13CONFIDENTIAL NOT FOR FURTHER DISTRIBUTION

CONTRACT DEVELOPMENT AND MANUFACTURING SERVICES

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Contract Protein Development and ManufacturingBoth 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 purified recombinant proteins

Purified proteins can be delivered in either a liquid solution or as a shelf-stable lyophilized powder

All final products are processed in line with cGMP requirements to guarantee purity, quality, and consistency

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CUSTOM MEDIA DEVELOPMENT, FORMULATION, AND TESTING

Component sourcing – including supplier qualification

Raw material testing (i.e. endotoxin) and screening

Comprehensive testing of final formulation

LARGE SCALE CONTRACT MEDIA MANUFACTURING (POWDER OR LIQUID)

30 – 500L production runs

cGMP manufacturing

Comprehensive testing services

Development and engineering runs

Aseptic fill in customized aliquots and packaging

Custom Media Development and Manufacturing

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Plasmid DNA ManufacturingSequence 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 filings

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Bioengineered Scaffold Development & Fabrication

TECHNIQUES· Emulsion Electrospinning· Co-axial Electrospinning· Post-Electrospinning Surface Modification· Sacrificial Fiber Electrospinning

MANUFACTURING CAPABILITIES· Lyophilization· Cryomilling· Surface modifications including Plasma Treatment· Immobilization of Biologicals

ANALYTICAL CAPABILITIES· Scanning Electron Microscopy (SEM) · Atomic Force Microscopy (AFM) · UV-Vis Spectrophotometry/ELISA· X-ray Photoelectron Spectroscopy (XPS) · Fluorescence Microscopy

Aligned Random Axially Aligned Tubular Grided

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Class ISO 7/5 cleanrooms for contract manufacturing

PICS certification

ICH guidelines

Regulatory submissions

Full qualification, validation, and documentation

Release and stability testing

Commercial Contract Manufacturing

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Aseptic Fill & Finish1. Identify critical components, perform a risk assessment, and find 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 fill, development runs, and engineering/validation run to validate your sterile-fill claim

5. Set manufacturing process/specifications and final product specifications based on consistent and repeatable data

6. Formulate & fill 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 filings

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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