Read what Protak’s CEO Phillip Godden has to say about his company, the new Enzyme Indicator technology and why he is so passionate to bring it to market worldwide…
I’d love to say that aseptic pharmaceutical manufacturing was my chosen subject matter – and that I’m an expert in the field but in all honesty I am still learning. I do, however, have a good general overview of aseptic manufacturing in pharmaceutical applications and appreciation of decontamination technologies. I also have a couple of years’ worth of experience focusing on vapourised hydrogen peroxide decontamination technology.
The main observation I would make about the industry is that it suffers huge pain, high cost and poor results from conventional biological indicators. Almost everybody I’ve spoken to has suffered from biological indicators one way or another.
What is the purpose of Protak and how do you predict its growth/development in the next few years?
We are currently in a trial phase – but don’t misinterpret ‘trial’; this technology is over 15 years old. The reason we are trialling is more for final commercial product launch than process or product verification. We aim to take data capture, provided by commercial companies, and present this to the key regulators of the industry as the only trusted and reliable decontamination technology.
In terms of growth we have a conservative business model that shows a very large business in a few years time. We speculate that this technology will revolutionise the current system. Our ongoing committed research plan aims to take EIs into all types of decontamination technology whether that’s ethylene oxide or chlorine dioxide, or any others that may arrive in future.
Who are you working with? Employees, associates, partners etc?
At the moment the project team is growing with a core of dedicated and exceptional talent. Working directly with Public Health England includes some of the very best people in the industry. Our suppliers have beeen cherry-picked. In terms of our product trial partners, we are again hoping to work with the best.
How did you come across EIs and is there anyone else promoting this kind of science?
I became aware of Enzyme Indicators through some work on the project that Public Health England were conducting around two years ago. At first I simply couldn’t believe such a technology could exist in such a reliable and solid platform. I was also thrilled by the potential that this offered my partners in the pharmaceutical industry.
The potential savings in time and money are not only huge but entirely within everyone’s grasp. It is a technology that will revolutionise everything; saving money, time and – potentially – lives.
The next two years were a challenge to secure the licence and raise finance. I suspect my future will be dominated by Protak Scientific – and introducing Enzyme Indicators to the world.
Enzyme Indicators have also been commercially licensed to a company called BIOtAK. They have a licence for use in enclosed chambers – for example in the washing and decontamination of surgical instruments. We have a good working relationship with BIOtAK and redirect interested parties accordingly.
What makes Protak the best people to bring EI’s to market?
I think really Protak was selected because we have a passion rarely seen in this sector. This isn’t just a commercial project to us, but an opportunity to do something for the greater good. This is a scientific discovery that deserves to be out there because it’s a far better solution than the current practice.
How has Protak and EI’s been received so far?
Protak and Enzyme Indicators have been received with typical pharmaceutical optimistic caution. I think that many people can’t quite believe such a revolutionary technology can actually exist.
People are looking to challenge the technology and find flaws. This is excellent for us because at each stage we are learning the exacting requirements of different applications. We have the capability to be fluid and adapt or simply provide the right answers when asked.
Everybody understands the technology quickly – specifically the advantages that it offers, without exception. I think that if we fast forward three to five years everybody globally will use EI’s. They are just a better solution.
There’s a lot on the website explaining the benefits of EI’s – and we’ve said how the product should appeal to both ‘bean-counters’ and scientists (a rare occurrence)… is there any downside or aspects that may cause concern to pharma companies moving over from BIs to EI’s?
In all honesty I think the only issue we will have is that the pharmaceutical industry moves slowly and is naturally and rightly cautious of anything new. However, I think we are well placed to change people’s perception. There is no downside.
Why are you looking for partners to take part in trials?
The reason we are looking for partners to trial the product right now is in order to collect independent data sets. We need to present this data to regulators such as the FDA and the MHRA. We are aiming for global acceptance of this new technology as the next gold standard.
Ideally we would like to present data from five different leading pharmaceutical manufacturers. This will verify the accuracy and effectiveness of this new technology beyond any doubt – with many tens of thousands of cycles as evidence.
This is a unique opportunity for pharma partners to benefit from this technology ahead of the pack.
- Tim Coles & Dr Helen Hale Article – Taming the Tyrannosaurus of Validation - 6th February 2018
- Exclusive ISPE Decontamination & Validation ½ Day Workshop and Focus Group - 18th January 2018
- The Shortfalls Of Biological Indicators For HPV Decontamination Validation - 7th September 2017
- Protak Features In Clean Air & Containment Review - 1st August 2017
- Protak Scientific At Pharma Integrates 2017 In November As Sponsor & Panelist - 1st July 2017
- Enzyme Indicators Proven As Viable Alternative For HPV Decontamination Validation - 20th June 2017
- Protak Scientific At The ISPE UK Summer Conference: Containment & Decontamination – 14/6 - 6th June 2017
- Howorth Air Technology Trials Enzyme Indicators Successfully - 26th May 2017
- Clean Air & Containment Review – “EI’s Will Eventually Take Over BI’s” - 5th May 2017
- Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators - 15th February 2017