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Group members: Kalaiselvi Mohan Raj SB09031 Nabilah bt Zulkefli SB09032

BSB 4172: Current Topics in Industrial Biotechnology (BIOPHARMACEUTICALS) Lecturer: Mr. Mohd . Fazli Farida Asras. Group members: Kalaiselvi Mohan Raj SB09031 Nabilah bt Zulkefli SB09032 Siti Nuratieah bt Iberahim SB09030 Nik Sharifah Suhaiza bt Nik Wan Ahmad SB09038

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Group members: Kalaiselvi Mohan Raj SB09031 Nabilah bt Zulkefli SB09032

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  1. BSB 4172: Current Topics in Industrial Biotechnology(BIOPHARMACEUTICALS)Lecturer: Mr. Mohd. FazliFaridaAsras Group members: KalaiselviMohan Raj SB09031 NabilahbtZulkefli SB09032 SitiNuratieahbtIberahim SB09030 NikSharifahSuhaizabtNik Wan Ahmad SB09038 Wan NurhafisyabtMiorNorazmi SB09043

  2. BIOPHARMACEUTICALS

  3. HISTORY • Modern biopharmaceuticals started with the discovery and manufacture of penicillin by Alexander Fleming. • Since then, the focus of the majority of biotechnological research has been in the field of pharmaceuticals. • The first substance approved for therapeutic use was biosynthetic 'human' insulin made via recombinant DNA technology was developed by Genentech, but licensed to Eli Lilly and Company, who manufactured and marketed the product starting in 1982.

  4. TIMELINE

  5. INTRODUCTION • Medical drugs produced using biotechnology • Made from: • Proteins (Antibodies) • Nucleic acids (DNA,RNA) • Living microorganisms (Virus and bacteria) • Produced by other than direct extraction from a native (non-engineered) biological source.

  6. A potentially controversial method involves transgenic organisms, particularly plants and animals that have been genetically modified to produce drugs. • The first such substance approved for therapeutic use was recombinant human insulin or Humulin.

  7. CLASSIFICATION

  8. USES • 1. Therapeutic proteins • ATryn, a human anti-thrombin protein made in transgenic goats that prevents blood clots in patients who don’t make their own version of this protein.

  9. 2. Treat anaemia • It is used in treating anemia resulting from chronic kidney disease • Erythropoietin (therapeutic agent) produced from Recombinant DNA technology in mammalian cell culture

  10. CurrentChallenges

  11. GLOBAL HEALTH CHALLENGES • New virus strains emergence- new influenza • Evolution of new diseases- new R&D • Neglected diseases- no cure

  12. FINANCIAL BARRIERS • preventive/ diagnosing tools are inaccessible, outdated, unsafe or ineffective • Capital demand- lack of fund

  13. INFORMATION BARRIERS • Many stages of pre-clinical studies about virus and diseases needed • Lack of information about innovator companies (experts & technologies )

  14. SAFETY & STABILITY ISSUE • very difficult and complex • challenges of selectivity, reproducibility and accurate quantifying • Lacking business skills • Public acceptance

  15. ACCEPTANCE & APPROVAL • difficult to patent the product (only limited numbers per year) • difficult to attain approval from FDA (many clinical trials needed)

  16. Current Approaches

  17. RESEARCH & DEVELOPMENT • Harnessing technical and human expertise • More research on new and neglected diseases (Collecting data and information) • Quality and safety standards (GLP) • Increase sales and marketing (product development for commercialization))

  18. INCREASE INVESTMENTS • public co-investments in venture funds • Bank-backed VC firms • Corporate venture capital (CVC) • Pension funds • Insurance companies • Individual investors • global funding opportunities • early-stage investments (policy holder)

  19. DIAGNOSTIC SOLUTIONS • Simpler instruments based on the adaption of existing detection platforms • Improved sample preservation and management • Novel detection technologies • Discovery of new biomarkers

  20. THERAPEUTIC SOLUTIONS • Fast, screening techniques (high-throughput screening) and new drug-finding technologies • Extensive libraries of chemical compounds for screening • Infrastructure and expertise insmall molecule drug discovery • Persistent and highly-knowledgeable employees who care about solving pressing health needs

  21. BENEFITS OF BIOPHARMACEUTICALS

  22. Improved the quality of life. • Medical innovation. (use of prescribed drugs, instead of expensive surgeries) • Affordable health care to all patients. • Increase job opportunities 

  23. IMPACT OF BIOPHARMACEUTICALS ON:

  24. SOCIAL ISSUES

  25. SOCIAL ISSUES • Being too dependent upon biopharmaceuticals. • Escalating rate of biopharmaceutical abuse.

  26.  Fraud and corruption running through the veins of the US pharmaceutical industry.

  27. POLITICS

  28. POLITICAL ISSUE ON BIOPHARMACEUTICALS • Political Determinants: Governments and Trade Agreements that Affect the Industry • All changes from importing and exporting are regulated by each countries administration that handles the regulations for drug import, export and production. • These organizations and administrations are the important political actors in the pharmaceutical industry. • Politics plays a role in the regulation of : (i) manufacturing, (ii) distributing and sale of pharmaceuticals • They want to make sure the medicines are safe and effective for all users. • Each nation has its own system for ensuring safety of distribution for drugs. • The Food and Drug Administration is the main regulatory body for pharmaceuticals in the United States and the EMEA regulates these medicines for the European Union. • Each body sets the regulatory standards for quality and control, then they enforce these laws.

  29. POLITICAL ISSUE ON BIOPHARMACEUTICALS • The roles of the government: [1] improve the national systems contributing to development of the industry [2] eliminate the conditions and factors that inhibit the fair and appropriate market competition principle [3] to intensively support what the government determines to be necessary from thenational strategic perspective [4] promote cooperation from medical institutions as and the healthcare professionals for the clinical trials.

  30. ECONOMY

  31. ECONOMY • Medical innovation creates economic value. • Biopharmaceutical support high-value jobs and stimulate regional and national economic activity • Attract biopharmaceutical investment and create clusters of companies centered around the biopharmaceutical sector to sustain economic growth.

  32. CONCLUSION • Use our knowledge to develop treatments for conditions where previously no treatment existed for better future healthcare possibilities. • If we can achieve this, there are hopes for patients everywhere in the form of new diagnostics, new treatments and eventually maybe even new cures.

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