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Ease of a Prefilled Syringe
   with the Stability of a Lyophilized drug




Innovative Delivery
to Enhance Lyophilized Drugs
LyoTip™ Delivery System




      How does LyoTip™ Work?
                                                                    Screw LyoTip™
    · ontainer closure system is prefilled
     C                                                               onto prefilled
     with a lyophilized drug.                                     syringe and attach
                                                                         needle
                                                                     (if necessary)
    · crews to a prefilled diluent syringe and
     S
     needle
    ·mmediate reconstitution as plunger is
     I                                                    Reconstitution
     pushed                                               and injection is
                                                           accomplished
                                                            in one step
    · piral chamber effectively reconstitutes
     S
     and simultaneously injects drug.



      Ease of a Prefilled Syringe with the Stability of a Lyophilized drug
    · ser friendly design favored by patients or practitioners eliminates need for separate
     U
     mixing steps
    · esigned for use with existing fill/finish and lyophilization process
     D
    · ay permit decreased use of cold chain handling
     M
    · ost effective, highly valued differentiation for SC and IV lyophilized drugs
     C



2
Flexible Configuration
                                ·yoTip™ is currently available in 1 ml and 0.2 ml sizes. Other
                                 L
                                 sizes may be produced upon request.
                                ·yoTip™ can be used with subcutaneous and intramuscular
                                 L
                                 injections, IV infusion, auto-injector, and oral administration.
                                · ecause the final assembly is done by the user, the system
                                 B
                                 can be adapted for diluent and needle type preferences.




                                   Lyophilized Formulation Optimization
                                · s a leader in Biotech Formulation, IntegrityBio has delivered
                                 A
                                 over 150 formulations for more than 100 companies.
                                · xisting or new lyo formulations can be optimized for
                                 E
                                 stability, speed of reconstitution, or other attributes.
                                · xperience with antibody, proteins, vaccines, peptides, and
                                 E
                                 other innovative molecules




  Preferred by Patients  Providers
· rd Party market study compared LyoTip™
 3
 to 4 other standard reconstitution and
 delivery methods.
· yoTip™ was chosen as the best in ease
 L
 of use, preparation speed, learning ease,
 portability, and economy.




  Enhance the Value of Your Molecule
· imple to implement as part of lifecycle
 S
 management strategy
· dds valued differentiation
 A
· engthens patent protection
 L
·Adapts to existing manufacturing




                                                                                                    3
About Our Team
                              Led by founder Byeong Chang, PhD, the IntegrityBio and LyoTip
                              team brings decades of combined industry experience to provide
                              our customers with a level of confidence unparalleled in formulation
                              development and contract manufacturing. Dr. Chang’s experience
                              spans more than 20 years including 11 years with Amgen, Inc. The
                              collective experience of the Integrity team includes formulation of
                              many leading biotechnology drugs including Epogen®, Aranesp®,
                              Rebif®, Kineret®, and Luveris®.



                                 easibility Studies provide Quick Evaluation of
                                  F
                                  LyoTip™ Delivery System
                              · e offer technical feasibility studies including lyophilized
                               W
                               formulation optimization, LyoTip™ fill and finish, and stability
                               studies.
                              ·yoTip™ intellectual property patents are issued and pending and
                               L
                               available for licensing.




                                 How Can the LyoTip Team Help You?
                              · e look forward to the opportunity of speaking with you to
                               W
                               discuss how LyoTip can help you attain your company’s goals.
                              ·Call (805)445-8422 in US, 82-42-864-1488 in Korea
                              ·Email info@integritybio.com
                                     info@lyotip.com
                              ·Website  ww.lyotip.com, www.lyotip.co.kr
                                       w




            Inc.                                    Korea
820 Calle Plano, Camarillo, CA 93012 USA            Migun Techno World #311 Yongsan-dong,
                                                    553 Yuseong-gu, Daejeon, Korea

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Reconstitution Device

  • 1. Ease of a Prefilled Syringe with the Stability of a Lyophilized drug Innovative Delivery to Enhance Lyophilized Drugs
  • 2. LyoTip™ Delivery System How does LyoTip™ Work? Screw LyoTip™ · ontainer closure system is prefilled C onto prefilled with a lyophilized drug. syringe and attach needle (if necessary) · crews to a prefilled diluent syringe and S needle ·mmediate reconstitution as plunger is I Reconstitution pushed and injection is accomplished in one step · piral chamber effectively reconstitutes S and simultaneously injects drug. Ease of a Prefilled Syringe with the Stability of a Lyophilized drug · ser friendly design favored by patients or practitioners eliminates need for separate U mixing steps · esigned for use with existing fill/finish and lyophilization process D · ay permit decreased use of cold chain handling M · ost effective, highly valued differentiation for SC and IV lyophilized drugs C 2
  • 3. Flexible Configuration ·yoTip™ is currently available in 1 ml and 0.2 ml sizes. Other L sizes may be produced upon request. ·yoTip™ can be used with subcutaneous and intramuscular L injections, IV infusion, auto-injector, and oral administration. · ecause the final assembly is done by the user, the system B can be adapted for diluent and needle type preferences. Lyophilized Formulation Optimization · s a leader in Biotech Formulation, IntegrityBio has delivered A over 150 formulations for more than 100 companies. · xisting or new lyo formulations can be optimized for E stability, speed of reconstitution, or other attributes. · xperience with antibody, proteins, vaccines, peptides, and E other innovative molecules Preferred by Patients Providers · rd Party market study compared LyoTip™ 3 to 4 other standard reconstitution and delivery methods. · yoTip™ was chosen as the best in ease L of use, preparation speed, learning ease, portability, and economy. Enhance the Value of Your Molecule · imple to implement as part of lifecycle S management strategy · dds valued differentiation A · engthens patent protection L ·Adapts to existing manufacturing 3
  • 4. About Our Team Led by founder Byeong Chang, PhD, the IntegrityBio and LyoTip team brings decades of combined industry experience to provide our customers with a level of confidence unparalleled in formulation development and contract manufacturing. Dr. Chang’s experience spans more than 20 years including 11 years with Amgen, Inc. The collective experience of the Integrity team includes formulation of many leading biotechnology drugs including Epogen®, Aranesp®, Rebif®, Kineret®, and Luveris®. easibility Studies provide Quick Evaluation of F LyoTip™ Delivery System · e offer technical feasibility studies including lyophilized W formulation optimization, LyoTip™ fill and finish, and stability studies. ·yoTip™ intellectual property patents are issued and pending and L available for licensing. How Can the LyoTip Team Help You? · e look forward to the opportunity of speaking with you to W discuss how LyoTip can help you attain your company’s goals. ·Call (805)445-8422 in US, 82-42-864-1488 in Korea ·Email info@integritybio.com info@lyotip.com ·Website ww.lyotip.com, www.lyotip.co.kr w Inc. Korea 820 Calle Plano, Camarillo, CA 93012 USA Migun Techno World #311 Yongsan-dong, 553 Yuseong-gu, Daejeon, Korea