Tag: <span>project management</span>

In the last few years, we have seen many biotech products approved by FDA. These products have gained public awareness because of their ability to treat several debilitating diseases with very minimal side effects, and thereby impact the quality of life for many people. As a result, the biotech industry is constantly in the news for its successes and programs to develop new therapeutics for many unmet medical needs. Immunomedics, Inc., a New Jersey biotechnology company, recently completed an expansion project that included new bioreactor manufacturing suites and support laboratories. Building on the company’s existing headquarters site and fully integrating the new capacity into the existing operational facility, the project spanned two years and was completed in 2003…

Manufacturing

The revolution in biotechnology has led to 133 biotechnology-derived medicines being approved by 2001 with sales of $22 billion. This is less than 10 percent of today’s total pharmaceutical market, but it is a rapidly growing sector. Biologics are predicted to grow to nearly $50 billion by 2008. Marketed biopharmaceuticals include several blockbuster products with multibillion-dollar sales. In recent years, biotechnology-derived therapies represented 10 percent to 20 percent of all new approved molecular entities and hundreds more are in development, including nearly 200 proteins in late-stage trials. Microbial and mammalian expression systems are typically used to produce biotherapeutic proteins (many companies are also working on transgenic expression systems). Microbial cultures (typically, Escherichia coli or yeast) are used to produce smaller, less-complex proteins or those where specific modifications, especially glycosolation, are not required…

Biologics Production Manufacturing

In the past, most large construction projects used a system called design-bid-build. Now, pharmaceutical companies planning cleanrooms have begun using an improved system, design-build, which can save millions of dollars and cut months from construction schedules. Design-build also can provide better quality end results than design-bid-build…

Manufacturing