A blessing in disguise: International standards for the biotechnology industry



original image

Regardless of the industry, standards are ubiquitous in our everyday lives and essential to the interconnection of people, businesses, and countries. Joachim Lonien, DIN – German Institute for Standardization, introduces the idea behind the ISO/TC “Biotechnology”.

original image

Regardless of the industry, standards are ubiquitous in our everyday lives and essential to the interconnection of people, businesses, and countries. Standardization seeks to consensually establish the best technical application for any given process in order to ensure consistent quality, minimization of risks, and interoperability. As a life scientist, I was surprised to see my natural reservation towards draconic documentation change. Life science standards are fundamentally important for the smooth transaction of data and repetition of experiments, and may help small and medium enterprises gain the international attention they deserve and require, in order to get their innovations noticed.

Every time I step off a plane I am impressed by everything that has not gone wrong. Sure, statistics is on my side, but an average transatlantic flight provides plenty of time to think about the overall complexity of commercial passenger flights and the enormous pool of potential errors. Yet the 2011 accident rate of 1 per 2.7 million flights [1] underlines the safety of air travel once more. With over 10 million flights per year in the US alone, however, there isn't too much room for flexible procedures. Over the course of aviation's 2000 year history, from earliest kite inventions to Boeing's Dreamliner and Airbus's A350, orchestrating smooth operations between countries, pilots, ground personnel, engineers, manufacturers, etc. has become exponentially complex. Maintaining daily operations is only possible through strict adherence to thousands of meticulously created protocols and standards: from the international exchange of data to the nuts and bolts and glues that are keeping the planes together.

Maintaining daily operations is only possible through strict adherence to thousands of meticulously created protocols and standards.

To some industries, however, standards present a blessing in disguise. The efforts necessary for the development of standards prevent many experienced companies and research facilities from actively participating in the creation of international standards. Especially fast-paced industries such as electronics and IT, which influence our lives in every possible way, require rapid development of standards in order to maintain a constant flow of innovative products and to help companies compete for market share. As a result, companies often rely on the creation of in-house (as opposed to international) standards that allow them to act quickly, but that may also prevent them from influencing their respective market significantly. Numerous milestones in technological development would not have been possible without the setting of standards, which in turn has led to the creation of economies of scale and made technologies available across borders.

original image

The same holds true for the biotechnology industry: since the invention of controlled fermentation centuries ago, biotechnology has gained significant presence in our daily lives: biofuels, pharmaceutical products, technical enzymes, and GMOs: Proper use of biological systems, living organisms and derivatives thereof, are of utmost importance in modern societies to guarantee environmental safety and health while meeting the demands of an ever-increasing global population – a population that has never been more connected through trade of tangible products and the exchange of data via optical fiber networks. In modern history, the functionality, soundness and validity of technical processes and systems used to create such products has been supported by technical standards.

Fit for purpose

A technical standard is a formal “document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose” (www.iso.org).

The quantum leap in technological progress humanity has experienced after the first industrial revolution and even more so during the digital (third industrial) revolution has opened up a whole new spectrum of opportunities for inventors (and investors). Progress, however, almost always leads to increased complexity and usually decreased transparency coupled with new risks.

Using standards, engineers can rely on recognized practices and approved levels of safety. Moreover, technical risks are minimized by using fit-for-purpose components that have been tested and proven to work for the intended application. Verification tests are carried out in international round-robin experiments prior to publication of an international standard. The international standardization organization (ISO) has published over 19 000 standards since its foundation in 1947. ISO standards are formulated in technical committees by experts from over 160 member countries, each represented at ISO through their respective national standardization body (NSB). Germany's national standardization body is DIN (German Institute for Standardization), which holds 19% of all ISO technical committees. After careful consideration and numerous valuable discussions with scientists from research, academia and industry, DIN has decided to propose the establishment of an international technical committee (ISO/TC) “Biotechnology”.

original image

The idea for a new technical committee on biotechnology is hardly new; in the mid-1990s, industry and research affiliated with the European Committee for Standardization (CEN) successfully implemented standards for large-scale production processes, performance criteria, and criteria for reaction vessels in Technical Committee CEN/TC 233 “Biotechnology”. The increasing use of disposable vessels, bioreactors and sensors (especially in the production of high-value products) underline the industry's interest in these items. Monetary savings correlate directly with savings in preparation- and clean-up time.

Moreover, in 1990, the EU-US task force on biotechnology research was founded to coordinate research programs between the European Commission and the US Government in order to reduce redundant experiments and increase efficiency on a global level. The “strategic plan 2011–2015” released in June 2011 underlines the importance of harvesting the innovative potential of this field. The task force focuses on animal biotechnology, bio-based products, environmental biotechnology, marine genomics, plant biotechnology, and synthetic biology; all of which are of significant international interest and have a high impact on a variety of stakeholders [2].

Standardized procedures would furthermore support quality assurance testing, as well as international GMP/GLP requirements and facilitate their implementation. It should be made clear that no attempt will be made to standardize academic research. The past decade, however, has shown that close collaborations between R&D facilities, innovative SMEs and large corporations leads to great advances and benefits all.

Patents in standards

The standardization work performed by experts from all over the world is a cornerstone in the progress of modern society. The importance of standards in any industrial field cannot be over stressed and if history is any guide, the default openness of standardization will continue to influence ingenuity. In contrast, the field of biotechnology and other life sciences traditionally revolve around intellectual property rights (IPR), which, by default grants the patent owner the right to exclude others from practicing the invention. Patents, however, are only as valuable as the innovations they stimulate.

Standard-setting organizations have traditionally been wary of the use of patents in standards due to the seemingly problematic licencing procedure, i.e. the negotiation of FRAND (fair, reasonable and non-discriminatory) conditions. Recently, these reservations have changed. IPR disclosures at standard-setting organizations have continuously increased between 1990 and 2005 [3]; a trend that is likely to be continued, considering the increasing importance of interoperability.

The incorporation of patents into standards has numerous advantages [4, 5], e.g.

• equal and accelerated access to licenced technologies;

• integration and improvement of complementary technologies;

• reduction of transaction costs for both licensees and licensors;

• Cross-licensing enables the development of better products in shorter cycles.

Beneficiaries of ISO/TC “Biotechnology”

Research organizations worldwide will benefit from the standardization work of this committee. Not only will they be able to incorporate the result of specific standards into their own research, but the TC would also enable researchers to participate in the process and share their knowledge for the greater good of biotechnological progress. Life scientists share a passion for discovering efficient tools and methods that help not only one organization but an entire industry. ISO/TC “Biotechnology” will also actively promote innovations. Companies, R&D facilities, NGOs could work out strategies for the introduction of globally accepted methods that would allow data exchange and integration. In return, this would allow non-participating scientists and customers of life science standards, the simple application of these methods and data formats and hence facilitate international collaborations. The underlying quality of the research would be documented in each standard, reinforcing its reliability and thus making them appealing to regulatory bodies, commerce, and research. Lastly, ISO/TC “Biotechnology” would provide an international platform to discuss sustainable and environmentally safe behaviour for participating parties and users alike, from small R&D laboratories to large-scale production facilities.

original image

As has already been proven, international collaborations on international standards foster innovation, shorten development cycles, and support sustainable research programs in life science. Science will advance more rapidly and more cost efficiently if researchers enjoy unrestricted access to knowledge and to validated experience of their peers.

For more information on ISO/TC “Biotechnology” please contact your national standardization organization or the corresponding author of this article (www.iso.org).

Joachim Lonien, DIN – German Institute for Standardization, Berlin, Germany