February 1, 2014
In the era of biologics manufacturing, chemical medicine production facilities are becoming the dinosaurs of the life sciences sector. Traditional chemical facility development and management systems are simply unequipped to support the highly sensitive — and highly regulated — process of developing and producing biological and biosimilar medicines. Renovating or building such facilities anew is a mammoth undertaking by any measure. All signs point to the value of evolving facility design and management to house more sophisticated biologic laboratory services.
Numbers Reveal Rising Demand
The biologics market is expected to skyrocket from US$162 billion in 2012 to $252 billion by 2017 — representing a projected compound annual growth rate (CAGR) of 9% over five years, according to a January 2013 BCC Research report. That reflects the growing interest in biosimilars and biobetters but covers all main product categories. Monoclonal antibodies (MAbs) are the fastest-growing segment, expected to grow at 11.8% CAGR from $51.5 billion in 2012 to $89.9 billion in 2017. Over the same period, other therapeutic proteins will grow, with a 7.5% CAGR from $78.8 billion to $113.4 billion, while the vaccine market is expected to reach $49 billion, with an 8% CAGR, from 2012’s $33 billion. Such rapid growth projections are especially striking given the relatively recent development of some such medicines. Biosimilars, for example, first became a viable US market option in 2010, when the US Patient Protection and Affordable Care Act provided a pathway for FDA approval. The projected value increase has motivated several major pharmaceutical companies to build new biologic production facilities, which typically cost over $250 million. Whether you are building new or updating existing facilities, smart design will be critical to meeting stringent compliance requirements — which are anything but an afterthought.
Facility Requirements
Adapting real estate for a biomedical functionality is newly challenging despite the fact that many pharmaceutical companies already have experience transitioning from production of one type of drug to another. With small molecules, retooling a facility to support different chemical medicine production has been relatively simple, requiring little more than a few systems adjustments. Reequipping a facility to support biological production, however, requires a significant overhaul to achieve the more sophisticated and stringent laboratory controls necessary for compliance. Indeed, to support the sensitive processes of working with cells, tissues, and organisms, biopharmaceutical companies must meet a range of facility design reviews and audits and strict facilities management procedures. Concerns include air quality, gowning areas, temperature consistencies, and waste systems.
Air Quality and Filtration: Because regulations stipulate more rigid particulate parameters for biologics facilities than for other types of life-sciences facilities, they must have robust environmental monitoring programs in place. Regulations also require higher air changes for these facilities, typically more than 20 per hour with no recirculation of air. Additionally, air-flow systems must be separate for different product development areas.
Gowning Areas: Facility design must accommodate the need for separate rooms or passages that ensure “clean” entry and “dirty” exits from laboratory areas. Those areas must allow for gowns to be removed and exchanged as personnel move from one classification of space to another.
Temperature consistency is important in every manufacturing facility or laboratory. But it’s even more vital to storing and handling living tissues, whose properties can fluctuate dramatically with even minor changes in temperature.
Waste Systems: Autoclaving systems must be in place for some types of waste and consumables before they can be removed from the site. Additionally, sinks for liquid waste must have capped drains, and chemical kill must be available for effluvient waste before discharge.
Facility Personnel Practices
Just as facilities must be set up to meet strict compliance codes, personnel must be properly trained and certified in compliant procedures. Safe and consistent practices are paramount. Because using live cells involves a great degree of variation from one batch to the next, employee mistakes can lead to costly production problems. One of the most common safety breaches cited by FDA compliance inspectors is that workers have not been properly trained or certified to work in biologics environments.
For example, cleaning guidelines mandate that floors, counters, and other surfaces be sterilized more frequently in biologics facilities than in many chemical laboratories. Also critical, multiple disinfectants must be used in rotation to prevent organisms from developing resistance to cleaning solutions. Updating those and other facility practices effectively requires new training and new tracking management mechanisms.
Rising to the Challenge
It is no easy feat to reconfigure a large production facility and its personnel. Nor has it been easy to revolutionize medicine by engaging in the pursuit of biological products. But with forward-thinking facility build-out and management, companies new to the biopharmaceutical industry can pursue tremendous opportunities to participate in an important new era in healthcare.
About the Author
Author Details
Roger Humphrey is executive managing director of the life sciences group at Jones Lang LaSalle; 1-908-698-1379; [email protected].
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