LifeTein in Industrial Production of Therapeutic Peptides. Phil Moore, PhD Director of Business Development LifeTein LLC, NJ, USA

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1 LifeTein in Industrial Production of Therapeutic Peptides Phil Moore, PhD Director of Business Development LifeTein LLC, NJ, USA 1

2 Outline Market and Technology Trend LifeTein s Technology portfolio LifeTein s Strategy of Synthesis Partnership with LifeTein 2

3 Peptide Market and Technology Trend Since 1970s, 43 launched peptides, 250 in clinical phase and >200 in pre-clinical Therapeutic peptides representing a 10 billion USD opportunity (over 1.5% of global pharmaceutical market) Therapeutic peptide pipeline 3

4 Peptide Market and Technology Trend Key classes of therapeutic peptides (2003) 4

5 Peptide Market and Technology Trend 5

6 Peptide Technology Trend Challenges to produce long peptides of up to 200 amino acids Challenges to produce peptides of up to kilograms and >100kg Peptide synthesis technologies: Solid-Phase Synthesis Liquid-Phase Synthesis Recombinant Technology Peptide Enhancing Technologies Peptide Delivery Technologies 6

7 Issues for traditional methods: Issues for solid phase: multiple steps; costs of high quantity of reagents; low productivity; time-consuming lyophilisation step. Issues for liquid phase: Low yield; only for short peptide synthesis; long cycle time. 7

8 LifeTein s Technology Portfolio: PeptideSyn TM Technology Mixed-Phase Peptide Synthesis (combination of solid and solution phase) Drug Substance 8

9 LifeTein PeptideSyn TM Technology Drug Substance 9

10 LifeTein PeptideSyn TM Ligation Technology 10

11 LifeTein PeptideSyn TM Technology Examples of HPLC profiles of crude products A: H-MEDSTYYKASKGC-NH2 B: H-MEDST(PTyr)YKASKGC-NH2 C: H-PKYLQNTLKLATGMRNVPEKQTT-OH D: H-MEDSTYYKASKGC-NH2 E: H-MEDST(PTyr)YKASKGC-NH2 11 F: H-PKYLQNTLKLATGMRNVPEKQTT-OH

12 LifeTein PeptideSyn TM Technology Advantages of PeptideSyn TM technology: Synthesizes fully protected peptide rapidly; Combines the advantages of both the solid and solution phase methods; Uses to scale up relatively rapidly, scale>100kg; Avoids solubility problems for long segments in solution phase; Shortens production cycle time; Increases yields and saves costs. 12

13 LifeTein PeptideSyn TM Technology LifeTein Peptide Enhancing technology: Glycosylation: addition of carbohydrate chain, etc. Amino acid sequence modification: non-natural amino acids Pegylation: polyethylene glycol molecules Cyclisation: disulphide bode between two cysteine residues, or by head-to-tail or side-chain cyclisation, forming an amide bond 13

14 LifeTein Facility: GMP Peptide Manufacturing 2L to 50L solid phase reactors; 50 to 500L solution phase reactors GMP and process develop area; dedicated GMP suites with air classification Weighing area; raw material quarantine area, drying area Vacuum, compressed air; purified RO/USP water; purification lab; lyophilization workshop; freeze dryer with kg final API per batch capacity Analytical systems for identity determination methods and purity determination methods;quality assurance systems:hplc, GC, IC, LS- MS, NMR, lyophilizers 14

15 LifeTein PeptideSyn TM Technology LifeTein Peptide Enhancing technology: Glycosylation: addition of carbohydrate chain, etc. Amino acid sequence modification: non-natural amino acids Pegylation: polyethylene glycol molecules Cyclisation: disulphide bode between two cysteine residues, or by head-to-tail or side-chain cyclisation, forming an amide bond 15

16 Please visit: 16

17 Understanding Life One Protein at a Time 17

18 We are partner of your growth! Thank you! Address: LifeTein LLC 20 Hearthstone Drive Edison, NJ 08820, USA Peptides: Telephone: Fax:

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