Regulatory Compliance for CMC Biologics - How Good Manufacturing Practices Can Help You

The continual change of the Chemistry, Manufacturing & Controls landscape is familiar to anyone in the biopharmaceutical industry, but the headache of compliance is one that CfPIE is determined to solve for biologics producers in the United States. Good manufacturing practices keep you ahead of the game - Every product, every employee, every time ensures your pharmaceuticals are the safest on the market.

Our CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars course is targeted for those involved in CMC development and implementation, keeping you ahead of the curve on emerging product categories like cell therapy, gene therapy, transgenic plant cell cultures and transgenic animals. If these areas of production are uncharted territory for your company, developing a good manufacturing practices policy and CMC-compliant regulatory practice policy will require a thorough understanding of the necessities, which our course provides over a three-day session. Specific attention will be paid to avoiding holds and market-approval delays, the costs for which can be astronomical. Concentrating on patient safety and avoiding delays in internal processes and manufacturing, the CMC Regulatory Compliance program will prepare your company to meet FDA and EMA requirements with confidence.

Good manufacturing practices are essential if your company is investing in the production of biosimilars, an emerging product category in the U.S. that stands to see exponential growth in the next decade. The high cost of entering this marketplace, estimated at $100 to $200 million per product by some reports**, is compounded by the practice of counter-detailing by patent-holding or former patent-holder companies, so ensuring your companies’ processes are above scrutiny is likely the easiest way to protect profit margin in these ventures. The risk may well be worth the reward: A recent Matrix Global Advisors report states that 15 of the 20 best-selling biologics in this country will lose their patent by 2020**. Companies that are prepared to enter the space by creating FDA-compliant CMC Regulatory and GMP policies will be well ahead of the game.

** Source: https://www.centerforbiosimilars.com/news/report-details-challenges-facing-the-us-biosimilars-market