Blog

There are several factors that have affected the growth and advancements of the Biotech industry over recent years. Over the last year in particular, we have seen a drastic increase in drugs and therapies being brought to market. It is evident that 2016 holds great opportunities for the innovation and production of novel drugs. Well-funded Biotech companies are now required to execute on the promise of these new drugs. The rising impact of manufacturing these drugs under GMP conditions is driving the Biotech industry to invest in technology to ensure quality and efficacy, while maintaining high levels of productivity. This has led to a strong adoption of enterprise asset management (EAM) systems within the industry.

What are the drivers of Biotech EAM demand?

FDA Approvals

The year 2015 saw an increase of FDA approvals of Biologics. The FDA’s Center for Drug Evaluation and Research (CDER) approved 45 new novel therapies. This broke the record for the most new drugs approved since 1996. Sixteen of these drugs were identified ‘First-in-Class’ for their innovative nature and eight were believed to be worthy of “breakthrough” therapy status. The FDA also approved more drugs to treat rare diseases than in any previous year.

In-house Manufacturing

The surge in FDA approvals has driven Biotech companies to boost their manufacturing, leading to a need for new manufacturing facilities. New startups, such as promising Cell Therapy companies, have their own labor intensive proprietary manufacturing, requiring them to retain a hands-on approach to their production processes. Large corporations with the necessary means of internal production are also increasing in-house manufacturing.

Outsourced Manufacturing

Drugs and therapies going into clinical trials and clinical productions are commonly outsourced. We are seeing contract manufacturing organizations (CMOs) building new facilities across the country to cater to a lack of in-house capabilities of Biotech companies. Commercialization and the desire of international corporations to have production in the United States are other reasons outsourced manufacturing is so prevalent. CMO’s are continuing to invest in their own Biotech production capacity.

Increased Capital Expenditure

In 2014 and 2015, a record investment in Biotech Company funding provided capital for progressing companies’ candidate therapies from the lab to manufacturing to clinical trials. Industrial Info Resources cataloged over $5 billion in Q1 2016 investment of both capital and maintenance dollars in the Pharmaceutical-Biotech industry, signifying a 100% jump over the first quarter of 2015.  Much of this investment is in expansion of biopharmaceutical manufacturing capacity.

What are some technological changes resulting from these drivers?

EAM

The Biotech industry is rapidly adopting many types of automation software to achieve their production and compliance goals. Maintenance and calibration software in the form of Computerized Maintenance Management Systems (CMMS) and Enterprise Asset Management (EAM) systems are usually early in the adoption cycle. Many times when constructing a new facility, it is the first GMP application supporting production for these companies. A trend driving EAM use is that many biotech companies, including small startups, have multiple facilities such as research and development, QA/QC labs, and manufacturing.  There is a demonstrated need for a harmonized method for ensuring all facilities are working productively and in compliance.

This need for EAM systems could not have come at a better time. Advances in technology have permitted EAM software to be developed for specific market needs. Those designed for the Life Sciences and Biotech industries include unique features such as robust calibration, Part 11 compliant paperless systems allowing for workflow automation, and the use of mobile devices (i.e. Microsoft’s Surface and Apple iPads).

Software Implementation Templates

The idea of Best Practices has been adopted by many industries including Life Sciences manufacturing. Software templates have now been developed to mirror these best practices. These templates provide a platform for new companies to jump start their implementations, while allowing more mature organizations an opportunity to harmonize their practices. Typically, these software templates can be deployed on CMMS or EAM to save time and money in the implementation process. Computer application validation can be greatly reduced as well.

Blue Mountain’s Own Experience

Blue Mountain has a long history of working directly with Biotech companies, spanning decades. We work with a great deal of customers and see these drivers at work firsthand. The high demand of these technological advancements causes us to make continuous updates to our own products in order to maintain our industry leadership and remain a top provider of EAMs for our customers. Biotech manufacturers are looking for an ‘out-of-the-box’ framework for GMP compliance. Our purpose built platform, Blue Mountain Regulatory Asset Manager (Blue Mountain RAM), is a fully integrated EAM, CCMS, and CMMS, designed specifically as a harmonization of calibration, maintenance, and validations systems into a single comprehensive solution for Life Sciences companies.

To learn more, watch our GMP Asset Management in New Biotech Facilities.

Sources:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm474696.htm

http://blogs.fda.gov/fdavoice/index.php/2016/01/2015-another-strong-year-for-patients-in-need-of-new-drug-therapies

http://www.bloomberg.com/gadfly/articles/2016-01-05/biotech-ipo-flurry-suggests-better-year-ahead

http://www.pharmexec.com/2015-fda-drug-approvals

http://www.fiercepharmamanufacturing.com/story/report-says-cmos-without-us-facilities-risk-being-left-out-hot-market/2016-02-09

http://www.marketwired.com/press-release/pharma-biotech-industry-capital-investment-tops-5-billion-first-quarter-2016-north-american-2088452.htm