Challenges In The Biopharmaceutical Industry And Ways To Overcome

<p>The world has seen the most advanced medicine in the last 30 years with tremendous improvement in biomanufacturing technology towards developing drugs. The rapid growth and changing market dynamics in biosimilars, biologics, and vaccines have prompted biopharmaceutical companies to build new facilities faster.</p><p>Since high throughput and versatile technology are used to manufacture these drugs, companies invest hundreds of millions of dollars to set up manufacturing plants. So, companies expect robustness and decreased cost of these drugs to stay competitive and regulated market.</p><p>Therefore, healthcare sector will always pressure biopharma industries to manufacture low-cost, high-yielding medical drugs with faster times to market. These drugs have complex physicochemical properties and must cope with regulatory authority demands before human use.</p><p>But we should understand the major challenges faced by this industry before investment.</p><p>The major challenges are:</p><ul><li>Lack of internal innovation and research capabilities in companies</li><li>Requirement of high yielding expression system</li><li>Unstable cell lines</li><li>Selection of media for high productivity</li><li>Lack of efficient process monitoring tools and proper characterization of the product</li><li>Lack of robust quantification methods during the product development stage</li><li>Contamination rate of the product</li><li>Scalability issues in both the upstream and downstream process</li><li>Bottlenecks in the downstream process</li><li>Manufacturing cost</li><li>Time</li><li>Stability of products</li><li>Stringent guidelines from regulatory authorities</li></ul><p><br />The advances in <a href="" target="_blank" rel="noopener">production technology</a> have brought significant improvements in upstream productivity. But there is such a single-fit solution in the downstream process. The bottlenecks can occur if equipment and machine are not integrated with higher-level supervisory control and data acquisition system. Most companies cannot integrate since most of the equipment is supplied by different companies with technology gaps.</p><p>The collaboration between industry and academia and regulator, development of high-yielding strains, stable cell lines, requirement of new accurate analytical tools such as PAT and MVDA for measuring, monitoring, and process modeling during the development stage, innovative manufacturing processes for cost-effective production and approaches towards process intensification are necessary to overcome the challenges.</p><p>&nbsp;</p><p>&nbsp;</p><p><span style="font-size: 10pt;"><em>This article was contributed by our expert <a href="" target="_blank" rel="noopener">Rajat Mohapatra</a></em></span></p><p>&nbsp;</p><h3><span style="font-size: 18pt;">Frequently Asked Questions Answered by Rajat Mohapatra</span></h3><h2><span style="font-size: 12pt;">1. What are the most important advances in biomanufacturing technology?</span></h2><ul><li>Implementing automation strategies in Single-Use Technology (SUT)</li><li>Using fiber base chromatography technology in the downstream process</li><li>Automation integration of complete process steps</li></ul><p>&nbsp;</p><h2><span style="font-size: 12pt;">2. What is the most important factor to be considered during downstream processing?</span></h2><p>Fewer unit operations and less processing time without compromising the drug product's quality and yield.</p><p>&nbsp;</p><h2><span style="font-size: 12pt;">3. What are the current trends in pharmaceutical product development?</span></h2><ul><li>Development of analytical methodology for Process-Related Impurity (PRI) and Degraded-Related Impurity (DRI) in drug</li><li>Mimicking industrial conditions in the lab during the product development stage</li></ul><p>&nbsp;</p><h2><span style="font-size: 12pt;">4. What is the pricing strategy in Biopharmaceutical industry?</span></h2><ul><li>Value-based pricing strategy to enhance customer acquisition and retention</li><li>Profitability is based on improving pricing and revenue management capabilities</li></ul><p>&nbsp;</p><p>&nbsp;</p><p>&nbsp;</p>
KR Expert - Rajat Mohapatra

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