1. Introduction to platform technology for Biopharmaceutical Industry K.Senthil Kumar Asso.Professor QIS College of Pharmacy,Ongole,Andhra Pradesh,India.

2. The biopharmaceutical industry is responsible for the production of therapeutic products through the use of mammalian cells modified for suspension culture. Biopharma medicines and drug products are manufactured in living organisms like bacteria, yeast and mammalian cells. The prefix “bio” refers to how drugs are produced. Biopharma is the subset of drugs produced by biological methods. Platform technology essentially involves the engineering of antibodies and biologics using linear process chemistry to enhance drug effectiveness.

4. Technology and process platforms are now used extensively in the biopharmaceutical industry, both throughout the various phases of product development and in the facilities used to manufacture clinical and commercial biopharmaceutical products. Platform processes are currently most established in the biopharmaceutical industry for the manufacture of monoclonal antibodies. Platform technology / platform process: a common or standard method, equipment, procedure or work practice that may be applied to the research, development or manufacture of different products

5. The use of platform technologies emerged in biopharmaceutical product development programs during the 1990s and primarily focused on monoclonal antibody production processes. The use of platform technologies represents considerable opportunities to reduce risk to patient safety, providing access to platform technologies with proven performance and known safety profiles. Platform technologies are considered a valuable tool to improve efficiency and quality in drug product development. The basic idea is that a platform, in combination with a risk-based approach, is the most systematic method to leverage prior knowledge for a given new molecule.

6.  It is a innovative’ tools for pharmaceutical companies in order to mitigate the time, cost and risk of developing new therapeutic drugs.  The words tool, technology and platform are often used interchangeably.  The use of platform technology has allowed for rapid and economical product development from the R & D to commercialization.  The concept of platform technology developed from monoclonal antibody (MAb) purification to facilitate process development, and technology transfer is equally valuable for the purification of protein subunit vaccine product.

7.  Reduction of process development effort, time and costs.  Prior platform data informs risk assessments on new process weak ‐ points, and focuses development effort where most needed.  Consistency in process performance and product quality.  Simplification of technology transfer activities to production facilities  Improved asset utilization: one facility / same equipment for multiple products  Documentation preparation can be simplified; e.g., only minor adjustments to production batch records may be required from one process (product) to the next.  Reduction in time and resources leading up to and including pre ‐ clinical and clinical studies.  Reduction in failure rates during manufacturing due to accumulated process experience.  Routine procedures for in ‐ process and batch release testing lead to reduction of errors. Advantage of Platform Technology

8.  Now the platform technologies seen as the elements of a paradigmatic change in pharmaceutical R&D are being applied to biotechnology product and process development in other industrial sectors.  Four important platform technologies that are finding application outside the pharmaceutical industry are combinatorial chemistry, High- throughput screening, Genomics, Bioinformatics.

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