Malvern’s Bioscience Development Initiative (BDI) is an independent, agile and entrepreneurial organization. It partners with industry and academia to rapidly identify and assess analytical problems and bottlenecks within biopharmaceutical development and manufacture, and to prototype, develop and deliver solutions. The initiative was established in 2012 to meet the evolving needs of a sector that is undergoing rapid change.

The past decade has seen biopharmaceuticals become the fastest growing class of therapeutic agent, with increasing numbers of novel molecules entering development every year. Underlying this is a fundamental shift in pharmaceutical industry investment and emphasis. The challenges of moving from the development of small molecule drugs to dealing with more complex biological materials are considerable and wide ranging. New analytical tools are needed, quickly.

What is Malvern’s BDI?
Malvern’s Bioscience Development Initiative is incorporated as Malvern Biosciences Inc. and is based in dedicated facilities in Columbia, Maryland (USA). This well resourced, growing team of high-level scientists, engineers, project and business managers is independent of, but synergistic with, the main Malvern organization.

Why was it set up?
Some of the biggest challenges in biopharmaceutical development lie in understanding both what can be measured and what will provide meaningful predictive information about product quality, and how these factors will evolve over time. In this environment, the traditional model of analytical instrument development, which can take a number of years, is too slow. The Bioscience Development Initiative was set up to enable industry players to partner and share their challenges, as a vehicle for Malvern to identify and target emerging technologies, and to provide fast-moving, agile technology development that bypasses the usual industry norms.

How does it operate?
Malvern’s ability to engage with both sides of the industry is critical. The BDI team works with end customers who have analytical needs and also with those who lead technology development, in established organizations or in small companies and academia, enabling effective communication and sharing of requirements and solutions between the two.

The Malvern team seeks opportunities within such organisations as universities and small start-up companies, establishing the resource required in order to bring the technology to market more quickly. Uniquely, embryonic technologies are often provided directly to pharmaceutical partners for review and assessment, exposing them to technologies they may not otherwise have seen and providing a low-risk opportunity to test out novel ideas. This quickly determines whether or not a technology is likely to provide a useful solution, which will ultimately decide if it is progressed through to the next stages of more traditional product development.

What are the outcomes?

This agile, well-resourced and dedicated program is enabling close collaborations between biopharmaceutical companies, technology innovators and leading academic institutions. By establishing such mutually beneficial relationships, Malvern gains real-time understanding of emerging industry requirements to which it can quickly respond, and the biopharmaceutical sector gets early access to, and influence on, the cutting-edge technology developments it so urgently needs.

Become a collaborator
Offering users of new technology very early access to prototype systems, at various stages of evolution, is fundamental to the operation of Malvern’s Bioscience Development Initiative.  These systems may range from the truly embryonic to more fully-developed instruments. We are actively seeking to engage with potential partners who have specific analytical needs and with whom we can share learning. We do this by providing access to emerging technologies and immediately feeding user experience back into the development process.