en · fr

Big Pharma engages SAL tech scouts to address tough internal challenges

How SAL was approached by a Pharmaceutical Multinational to tackle their “real-time cleanroom monitoring challenge”.

Regular environmental monitoring and maintaining a comprehensive sterility control program is critical in pharmaceutical manufacturing. Yet curiously, the microbial monitoring process has a predominant reliance or preference for anachronistic techniques such as the use of settle plates

When SAL was approached by a Pharmaceutical Multinational to tackle their “cleanroom monitoring challenge”, the company had identified that relying on this dated, albeit robust and dependable, method was creating a substantial and costly bottleneck in their supply chain. Moreover, the procedure was acutely vulnerable to human error and challenging to manage on the data front, therefore causing a troubling gap in detecting and monitoring contamination trends.

The idea of utilising external parties to solve internal challenges is not new to big pharma, although it is no secret that they were latecomers to the open innovation party. Understandably perhaps as the entire industry was structured around the fierce protection of each company’s own intellectual property giving the whole sector a notorious reputation of being inward looking in the search for solutions. But with the growing pressures of increasing R&D costs, impending patent expiration, competition from generic manufacturers, the rising consumer expectation for cheaper and more effective therapeutics etc. the old conservative and progressively unsustainable model needed a rethink. In spite of this enlightenment, the majority of big pharma’s R&D pipeline is sourced via the more closed end of the open innovation spectrum. Recognising this tunnel vision, our Pharmaceutical client approached us to push the envelope on the sourcing of knowledge, technologies and expertise on their immediate challenge. 

The approach that was taken to this search was consistent with SAL’s overall methodology: i.e. Specify-Search-Select-Secure

Image

Preliminary discussions between SAL and the Pharmaceutical manufacturer, including a site visit by the search team to contextualise the challenge, culminated in an agreement that there was a need to uncover a technology solution that would allow rapid detection, identification and quantification of viable contaminating microorganisms suitable for a cleanroom manufacturing environment. Essentially an all-encompassing rapid microbial method (RMM)

The search specification is the main tool used to engage our international intermediary network. This is why a clear definition of the challenge is so vital to get right at the outset. Through briefing our global contacts and our own internal research team’s search efforts, SAL uncovered a diverse population of internationally dispersed companies/organisations with potential technology opportunities that met or closely matched the specification. Each of these potential solution providers were contacted personally and the appropriate contact interviewed as to the strength of the technology solution they offered, its IP situation, technology readiness level (TRL) and other significant issues e.g. future development direction, previous commercial dealings etc. This step is also important in determining if the potential new technology solution provider has a technical, structural and cultural framework that will complement our client’s own organisational culture. Experience has shown us the better the match; the more likely a successful collaboration can be achieved.

Our final selections spanned from commercially available technologies to emerging technologies. What was more interesting though was that a considerable number of solutions that emerged from unlikely sources outside the pharmaceutical/biotech industry.

For example we found that a software technology utilising an algorithm that was able to detect the oil content in olives using mathematical features (undetectable by humans) extracted from digital images was also capable of being transferred and used to detect, identify and quantify microbes on a sample plate without the need for advanced and time-consuming analytical techniques.

Other technologies found emerged from the food industry where “electronic noses” used to detect contamination in food had the potential to be reengineered for the detection of microbes relevant to and at the sensitivities necessary for pharmaceutical cleanroom environments.

SAL categorised the 22 opportunities according to the fundamental property exploited by the technology: these categories included: Growth based, direct measurement and cell component analysis. Novel and close to industrial readiness technologies were presented for each category.

Our internal investigation and wider network correspondence revealed that the need for an all-encompassing technology that detects, quantifies and identifies viable contaminant microbes is still something of a magic bullet in industry. Whereas most developments appear to address the speed and ease of identification, hardly any innovations combine all the aforementioned parameters. During some interactions with potential solution providers and industry authorities, it was implied that such a ‘catholicon’ would be an overkill or over complication and doubt was thrown on achieving this ideal solution. In contrast, some experts believed that this type of innovation is probably achievable and the reason it has been elusive so far is because there has been little impetus from industry in spite of the need due to complacent attitudes and in some cases the discouragement brought about by the misconception of regulatory barriers. In fact, the issue of regulation is arguably one of the reasons why RMMs have been more easily implemented in food as compared to pharma industries.

Commercially available opportunities such as some of the ones presented herewith have the attractiveness of validation and cGMP certification whilst emerging technologies have a desirable flexibility to be further developed to satisfy the unfulfilled potential.

The pharmaceutical company’s engagement with SAL was undertaken to landscape before engaging with potential development partners. It is pioneering initiatives such as these that will lead to resurgence in research and development and with the necessary innovation the prospect of a quantum leap in this important field will be realised. The value that SAL delivered in this project was fully recognised by the client as evidence by their comment below.

“We gained a very good insight into the current state with respect to microbiological control, ‘ready now’ technologies to those at a proof of concept level of readiness. I do not believe that our company could have achieved this in-house”.


Prepared by Fatuma Baraza

 

Image