uk manufacturing perspective - bia · uk cell and gene therapy manufacturing capacity, 2016 to 2019...
TRANSCRIPT
Dr Stephen Ward
Chief Manufacturing Officer
Cell & Gene Therapy Catapult
& Chair of BIA MAC
UK Manufacturing Perspective
UK biomanufacturing perspective
2019BioProcess UK
Dr Stephen Ward,
Chief Manufacturing Officer
Source EudraGMDP (Nov 2018 and Nov 2019)
Analysis Marcel Kuiper
0
5
10
15
20
25
30
35
40
45
Blood productsImmunologicalproducts
Cell therapyproducts
Gene therapyproducts
Biotechnologyproducts
Human oranimal
extractedproducts
Tissueengineered
products
Number of licences for Medicinal Products with Marketing Authorisation
2018 2019
0
10
20
30
40
50
60
70
80
90
Blood productsImmunologicalproducts
Cell therapyproducts
Gene therapyproducts
Biotechnologyproducts
Human oranimal
extractedproducts
Tissueengineered
products
Number of licences for Investigational Medicinal Products
2018 2019
Source EudraGMDP (Nov 2018 and Nov 2019)
Analysis Marcel Kuiper
0
5
10
15
20
25
30
35
40
45
Blood productsImmunologicalproducts
Cell therapyproducts
Gene therapyproducts
Biotechnologyproducts
Human oranimal
extractedproducts
Tissueengineered
products
Number of licences for Medicinal Products with Marketing Authorisation
2018 2019
0
10
20
30
40
50
60
70
80
90
Blood productsImmunologicalproducts
Cell therapyproducts
Gene therapyproducts
Biotechnologyproducts
Human oranimal
extractedproducts
Tissueengineered
products
Number of licences for Investigational Medicinal Products
2018 2019
•No increase in licenses•Static investment market or growth in existing
facilities?
Cell and gene therapy GMP manufacturing in the UK 2019 survey
UK wide MHRA licensed cell and gene therapy manufacturing sites
-Commercial pipeline facilities
-CDMO
-Academic and public translational centres
ct.catapult.org.uk/manufacturing-surveys
UK MHRA-licensed cell and gene therapy manufacturing sites
26 Facilities (up 1) 8
Dedicated gene therapy manufacturers (up 2)
12 Dedicated cell therapy manufacturers
(down 3)
6 Multifunctional manufacturers (up 2)
~7,819m2 Cleanroom footprint (up <5%)
~8,354m2 In-house QC footprint (new data)
72% Overall booked capacity (95% for gene therapy)
1,139 Full time employees (new data)
146 Cleanrooms 5 Cleanrooms per facility (median) 9
Commercial Pipeline developers (up 2)
7
Manufacturing facilities dedicated to gene therapy
Number of gene therapy dedicated manufacturing facilities have increased by 2 vs 2018
❖ 49% total cleanroom operational space
❖ Largest number of commercial facilities
❖Highest staffing levels
❖ Increased viral vector demand for genetic modification driving increased capacity built
❖ Supply of AAV is particularly restricted but should start to improve
56 Cleanrooms
604 Full time employees
95% Average booked capacity
3,889 m2
cleanroom footprint
8
Multifunctional manufacturing facilities
Number of cell and gene therapy
manufacturing facilities has increased by 2
vs 2018 due to expanding capabilities into
viral and gene therapy work
38 Cleanrooms
366 Full time employees
84% Average booked capacity
2,480 m2
cleanroom footprint
9
Manufacturing facilities dedicated to Cell therapy
52 Cleanrooms
169 Full time employees
53% Average booked capacity
1,450m2
cleanroom footprint
Number of cell therapy dedicated
manufacturing facilities have decreased
by 3 vs 2018 becoming multifunctional
❖ 3 Facilities have added viral/gene therapy work to their capabilities
❖ 18% total cleanroom operational space
❖ Largest number of academic translational sectors i.e. lower footprint and staff
❖ Large spread of capabilities → strong and diverse manufacturing base for clinical through to commercial supply
Sustained growth (>80%)
102 99
121138
4300
5124
76847819
0
1000
2000
3000
4000
5000
6000
7000
8000
0
20
40
60
80
100
120
140
160
2016 2017 2018 2019
Cle
an
roo
m f
oo
tpri
nt
(m2
)
Nu
mb
er o
f cl
ean
roo
ms
UK Cell and Gene Therapy Manufacturing Capacity, 2016 to 2019
Manufacturing Cleanrooms Cleanroom footprint
* **
***
*
➢ Numerous planned expansion projects
➢ Over 6,000m2 of additional total footprint are in the process of construction handover mainly in gene/viral vector arena
➢ AAV manufacturing capacity should start to improve
➢ Increased throughput will require increased analytical QC services
Looking forward
* Figures for 2016 and 2017 do not include in-house data for TC Biopharm, which obtained an MIA(IMP) licence in 2015
** Figures for 2018 have been updated since this report was last published in 2018 to include data for TC Biopharm and Meira
GTx and data corrected by other organisations
*** Cleanroom footprint for 2019 does not include data for Allergan
11
Conclusions
➢ There is continued investment in UK facilities, technologies and manufacturing capacity
➢ Biggest growth seen in commercial viral vector sector
➢ Demand outstripping supply ( 72% full)
➢ Gene therapy facilities are full but planned expansions should improve this
➢ Cell therapy facilities have limited capacity
➢ UK has spread of cell and gene therapy capabilities building a strong base to progress therapies through to commercialisation
➢ Increase in commercial provision needed to ensure growth is captured in UK
➢ Nr of employees have doubled within a year and even more highly skilled jobs will be required
Cell and Gene Therapy Industry
Skills Demand Survey
bioProcessUK Conference
27th November 2019
http://ct.catapult.org.uk/manufacturing-surveys
Survey overview
75% industry response rate
75% of industry companies surveyed
(41 out of 55 companies)
>95% of industry capacity
The 41 companies who have completed the survey
take up >95% of the industry capacity (people employed)
2019-2024; Cell and Gene employment to double
14
6,4203,895
1,7203,033
15
Manufacturing, PD and AD Skills shortage
Skill area Total headcount
2019
Forecasted total
headcount 2024
Increase Increase %
Level of concern raised during
interview Research and Development / Discovery
590 1080 +490 83% -
Manufacturing (including Engineering support and H&S)
491 1456 +965 196% +++
Supply Chain and Logistics (note: some respondents included these figures in Manufacturing)
104 306 +202 194% +
Process Development (including analytics)
623 1214 +591 95% ++
Regulatory Affairs
66 156 +90 136% +
Total Quality (including QP, QA and QC)
502 919 +417 83% ++
Commercial (including clinical trials)
208 511 +303 146% +
Support Services (such as HR/L&D, Finance/Payroll, IT, Comms/Marketing)
345 580 +235 68% -
Other 104
198 +94 90% -
Total 3033 6420 +3387 112%
16
Forecasted source of skills
Cross sectoral learning in high value manufacturing areas will be necessary to leverage the full value of the UK proposition
Skills a global weapon to growth and investment
Act now
For industry expansion to not be delayed – 76% of respondents believe that a lack of skilled and experience people will result in expansion being delayed
Opportunity
For UK to attain global investment
Skills Strategy
Respond to skills demand data and create an industry skills strategy
Funding
Apply for funding to deliver the industry skills strategy alongside industry investment
18
Press release today
http://ct.catapult.org.uk/manufacturing-surveys
HUGE thank you to:
• All survey participants
• ATAC coordination team who lead survey
• UKRI and ISCF for providing core funding for Apprenticeship co-ordination and ATAC support
• MMIP who continues to support this programme
Cell and Gene Therapy Catapult is a trading name of Cell Therapy Catapult Limited, registered in England and Wales under company number 07964711, with registered office at 12th Floor Tower Wing, Guy’s Hospital, Great Maze Pond, London, SE1 9RT. VAT number 154 4214 33.
12th Floor Tower WingGuy’s Hospital
Great Maze PondLondon SE1 9RT
Twitter: @CGTCatapultCell and Gene Therapy Catapult is committed to ensuring high standards of research integrity and research best practice in the activities we carry out. We subscribe to the principles described in the UK concordat to support research integrity.