My time working with the manufacturer of the AstraZeneca drug substance
Little did I know then what I know now
Background
In early 2013, I was contacted by the Technical Director of the UKs HealthTech and Medicines KTN (as it was then), now Health KTN.
He explained that no UK Life Sciences company had been successful in bid submissions to the first two rounds of the UKs Advanced Manufacturing Supply Chain Initiative (AMSCI).
He went on to say that the Office for Life Sciences was not happy with it. The feedback they had received was that the bids were heavy on science, but showed little understanding of the manufacturing supply chain. That was not a surprise to me!
Given my background, he asked if I would be open to a 4 day consultancy project to find a UK based life sciences company that could fit the bill as a candidate to submit a bid for Round 3. The brief was to attend the launch meeting for Round 3 and 4, then use my extensive network in biopharmaceutical supply chain strategy and management to identify a target company, and sign them up.
I’ve never been one to turn down a challenge!
The launch meeting was held at The QEII Centre, the largest dedicated conference and exhibition space in central London.
The Government account of this £120 million funding competiton for manufacturing supply chain companies stated:
“AMSCI is a funding competition designed to improve the global competitiveness of UK advanced manufacturing supply chains. £120 million is available for rounds 3 and 4, and the competition is open to all organisations that are part of a manufacturing supply chain. This funding is available to support research and development, skills training and capital investment. It will help UK supply chains achieve world-class standards and encourage major new suppliers to locate in the UK.”
Michael Fallon said:
I cannot stress enough the importance of developing strong supply chains if we want major manufacturers to invest in this county.
In the new rounds of AMSCI we will welcome applications from foreign investors who wish to establish or strengthen their manufacturing presence in the UK.
A day at the QEII Centre
On the day of the meeting, we were sat in tables of 8 people around the room. Michael Fallon, one of a breed of politicians we no longer see (IMHO only), gave an excellent opening address. As the day progressed, people around the table began to chat, as they do. On our table, a gentleman representing a low carbon vehicle developer, began to talk about the biotech industry. Curious as ever, I asked him how he knew about it.
“I’m the Chairman of Oxford BioMedica”, he revealed.
Well, you could have knocked me down with a feather duster…
…and the day ended with me being invited to visit the site to meet with Oxford BioMedica’s Director of Manufacturing.
Next, a day at Oxford BioMedica’s facility in Cowley, Oxford.
It wasn’t difficult to find the site in Cowley. I had previously worked as a senior manager at the site for two previous owners, British Biotech and OSI Pharmaceuticals. It overlooked the BMW manufacturing plant in Cowley, where we could watch the Mini’s rolling out, in various colours and shades, by the hundreds and thousands (not in work time, of course😉).
Oxford BioMedica (OXB) had purchased a biologics manufacturing facility on the site, known as Harrow House.
OXB was then, and still is a Contract Development and Manufacturing Organisation (CDMO, providing scale-up solutions and commercial supply of viral vectors to pharmaceutical and biotech companies in the fast-growing cell and gene therapy field.
The day went well, as the Manufacturing Director was up for new ways of working, and surprise, surprise, the Head of Supply Chain had been a master production scheduler in my team at Bayer. I left with commitment from them to the drafting of a consultancy agreement for signature. Within a week I was signed up.
Work begins with ‘what is’
As ever, I begin the assignment with a current state assessment. This involves mapping the inbound supply chain, the internal manufacturing flows, and the outbound journey to the next stage. The various items to be procured are identified, their suppliers, and data such as lead times and shipping conditions (mainly cold chain) are collected and documented.
Inside the plant, data on the stages in the process flow, batch sizes, production cycle times, waiting times, and a significant amount of other data were collected and documented, and so it went for outbound.
Now it’s the ‘to be’
Now we had detailed the current state supply chain, it was time to work out the future state, or what is ‘to be’.
For this bid to be classed successfully as ‘an advanced manufacturing supply chain initiative’, it had to be something of exceptional merit, given no other life sciences company had achieved a successful bid to date. I was confident though, because the company had good skilled people and the Director of Manufacturing was fully on board.
Knowing this was a gigantic challenge, I reached into my LinkedIn network for a suitable ally. It turned out to be a Royal Academy of Engineering Professor at Cranfield University—a former medic who had turned to designing Jaguar Cars! Perfect for an academic partnership on the project. He is still a very good friend today.
He put me in touch with a fellow Welsh person, who happened to be Head of Innovation at a hospital network in the West Midlands, UK. Another perfect partner to provide the NHS perspective. She is still a very good friend today.
Together, we were ready to work with OXB to deliver an end-user focussed model for developing gene therapy products—and the Office for Life Sciences (part of the Department for Business, Innovation and Skills (BIS) at the time) was delighted with the prospect!
How did it turn out?
Cutting to the chase, the bid was successful and OXB received the funding sought, see the Press Release below:
Oxford BioMedica Wins Significant Funding via a Competitive Award from UK Government’s Advanced Manufacturing Supply Chain Initiative
Here is an extract:
Oxford, UK – 11 September 2013: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, announces that it has been selected as a winner of a funding award under the UK Government’s Advanced Manufacturing Supply Chain Initiative (AMSCI), in recognition of the Company’s potential to become a world-leader in Advanced Therapy Medicinal Product (ATMP) manufacture and supply chain expertise.
Oxford BioMedica led the successful bid with four other UK-based participants: the Heart of England NHS Foundation, Cranfield University, Cell Therapy Catapult Ltd and Biotec Services International Ltd (together, the “consortium”). Subject to due diligence and final confirmation by Birmingham City Council, the consortium has been awarded a £2.4 million grant, of which Oxford BioMedica will receive £1.8 million, and a £5.3 million loan to Oxford BioMedica which is repayable by March 2017.
Government visits OXB for our pats on the back.
What followed was a get together of the winning team with representatives from the Office for Life Sciences, some very clever, young civil servants, and the fund administrators.
I got to the Cowley site early, and parked in my usual spot, which they had let me use for the duration of the project. It was right next to the open plan office I used to sit in, and the conference room to be used for the meeting.
I used to nab whatever desk was free in the office. The staff were mainly scientifically qualified and trained, and they would clear a space to fit me in if it were necessary.
About half an hour before the start of the meeting, I had a phone call from the Director of Manufacturing, asking me (embarrassingly) to move my car. I popped out of the office and duly shifted the car down the road towards the Unipart Logistics facility.
Walking back, I could see a Porsche heading towards ‘my’ spot and parking up. Out stepped the CEO of the Cell & Gene Catapult, one of the partner organisations that I had never seen visit the site.
When it came time for the meeting, we all sat around the conference table for introductions and the congratulatory proceedings. When the then OXB CEO was asked who had started the whole thing, the CEO said it was the Chairman, which was half right, but only half. Instinctively, I put my hand up to rebalance the equation, which the OXB CEO acknowledged, but not with much enthusiasm.
There was silence for a moment or two, then proceedings moved on. The day ended with the Office for Life Sciences folk leaving with that important first AMSCI award in the bag.
What happened next?
Soon after, the Director of Manufacturing I had been working with was fired. My assignment ended pretty soon after.
The partners I’d found, named in the Press Release above (Heart of England NHS Foundation Trust and Cranfield University), continued with their work on the project, but over time they too ceased work and there is no evidence that the ‘end-user focussed model for developing gene therapy products’ had been delivered from the taxpayer money invested.
What has all this got to do with the AstraZeneca drug substance?
OXB went on to develop, manufacture and commercially supply the viral vector (adenovirus drug substance) for the AstraZeneca SARS-CoV-2 injections, as the Press Releases below recount chronologically:
8 April 2020
Oxford Biomedica joins Consortium to rapidly develop a COVID-19 vaccine candidate
13 May 2020
Oxford Biomedica receives MHRA approval for the first two manufacturing suites in Oxbox
20 July 2020
1 September 2020
6 October 2020
Oxford Biomedica receives MHRA approval for fourth manufacturing suite in Oxbox
23 November 2020
Oxford Biomedica notes AstraZeneca’s AZD1222 met primary efficacy endpoint in preventing COVID-19
30 December 2020
18 January 2021
Prime Minister Boris Johnson formally opens Oxford Biomedica’s manufacturing facility Oxbox
1 July 2022
Oxford Biomedica signs new three year agreement with AstraZeneca
In summary, this tells us the AstraZeneca SARS-CoV-2 injections were developed, manufactured and supplied at breakneck speed, not by AstraZeneca or Oxford University, who would have been passive observers only. Remember, AstraZeneca has no capability to develop these products and Oxford University certainly doesn’t.
Aside from that, it is the breakneck speed that is the real concern. How could MHRA award a Manufacturing and Import License (MIA), which would have been required to undertake the development and manufacture, in the space of a few months, while only ever carrying out a virtual inspection?
That is just plain impossible, unless all the Regulatory aspects had been totally ignored.
More to comes on this as I dig deeper…
Hedley
many thanks; like a good novel; where will it take us? Listened to Kevin Walmsley talk about supply chains in China; and how China seems to have a very strong hand there https://www.youtube.com/@Inside_China_Business/videos
it would seem the centrality of supply chain issues; are off the radar for nearly everyone
How corruption has become the standard operating procedure.