GMP Asset Management in a New Facility: Booming Biotech Industry

Booming Biotech Industry

The overall market and drug development activity in the Biotech industry is explosive. There are several figures that point to this level of activity. Since the 2000s, there have been two major periods of record numbers of Biotech IPOs – (2004-2007) and (2013-present) – as seen in the Bloomberg graph.

Over the last 3 years (2013-2015), the number of IPOs have returned to the same levels experienced in the early 2000s. The significance of the today’s industry growth as compared to the early 2000s is not in the number of IPOs, but rather the total investment size of the IPOs. On average, 10% more of the Biotech IPOs today as compared to early 2000s are valued over $50 million. These numbers are based on a recent Bloomberg article.

Manufacturing Growth and Drug Development

The IPOs are just the foundation of the growth to come for Biotech drug development and manufacturing. There are an increasing number of Biotech and Biopharmaceutical drugs in development, clinical trials and nearing production.

Because of the proprietary nature and the complexity of Biotech and Biopharmaceutical products, in-house manufacturing is a growing trend within the Biotech industry. Unlike many other Life Sciences companies that can benefit from outsourcing as a way to achieve low cost, scalable manufacturing, Biotech companies are investing in building or buying new facilities and providing their own unique manufacturing capabilities. They are also establishing these production facilities and supply chains significantly earlier in the life of their company and products.

Building production facilities under the constraints of this competitive, fast moving market presents significant challenges. The production process has many complexities including:

  • Proprietary technology for cell manipulation
  • Supply chain (the patient’s own cells, cell manipulation, scaling)
  • Developing manufacturing capabilities
  • Fast moving and competitive environment

GMP Asset Management in a New Biotech Facility

At Blue Mountain, we see an increasing number of new facilities being built or purchased in the Biotech industry. This growth is occurring within our customer base as well as in general within the Biotech industry. Because we work directly with over 50 top Biotech companies including four of the hottest focused on CAR-T cell therapy, we have firsthand experience in understanding GMP needs in a new Biotech facility and the best practices surrounding new equipment, validation, record management, and automation. We’ll cover these best practices in this blog series. On November 17th at 2PM, we’ll host a live webinar titled: GMP Asset Management in a New Biotech Facility. The webinar will be followed by a question/answer session. I encourage you to register early as space is limited to 100 registrants. You can register here.

This Clear Blue series will cover what we’ve learned working with Biotech companies and the Biotech best practices for establishing a new facility and driving compliant, efficient processes from the very beginning.

Look for the next blog in this series that will cover the challenges and complexities of building new production facilities.

Join us for a Live Webinar

Throughout this series, we’ll discuss the best practices for GMP asset management in new facilities with a special focus on the unique needs of Biotech companies. We’ll cover the importance of implementing an EAM/CMMS early on in a new facility, handling new and transferred equipment, driving process consistency and automation, managing records, validating software and strengthening FDA compliance. The series will be followed by a live webinar on 11/17 that will include a live question and answer session. I encourage you to join us for the webinar, as well as continuing to read the rest of the series.

Register Now for the Live Webinar

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