Friday, June 05, 2020 4:28:37 AM
W.Sherlock A.Barquero N.Hussain S.Hsieh M.Scott
Advent Bioservices, London, London, United Kingdom
Available online 23 May 2020.
https://doi.org/10.1016/j.jcyt.2020.03.331
Background & Aim
In recent years, the UK cell and gene therapy industry has expanded rapidly. Cleanroom space capacity has increased during the last five years to a total of 7,819m2. In 2019, cleanroom facilities in the UK ran at 72% of operational capacity on average with 80% generally considered full. This demand has been driven by the success of the UK in capturing a disproportionately high level of investment and clinical trial activity. Between 2014 and 2019, the UK initiated 112 new ATMP clinical trials which was the highest total figure for any European country. This increase in the number of candidate treatments is projected to increase the production of ATMPs from hundreds to tens of thousands per year by 2028, resulting in strong demand for GMP manufacturing services and expertise in commercialisation and scale-up of manufacture.
Advent Bioservices began activity as a cell therapy contract development & manufacturing organization in 2016 and is in the process of building a state-of-the-art multiproduct GMP production facility outside Sawston in Cambridgeshire, which will allow the scale up of current commercial production and the provision of contract manufacturing services to meet the growing demand for such services in the UK.
Methods, Results & Conclusion
The Sawston facility is located just 7 miles outside Cambridge city centre with excellent transport links to Central London, London Stansted airport and is 4 miles from the M11 motorway. The facility consists of 1700m2 of GMP lab space, 325m2 for process development and an additional 1450 m2 for future expansion. Initial construction work has focused on the building of 2 separate GMP suites with grade B/C classified areas, in house QC testing and office space as well as a multipurpose cryogenic storage unit.
The entire facility will operate under a comprehensive IT infrastructure including eQMS and an eBMR, with a LIMS with secure storage for client documents and paperless systems. Clients operating within these suites will benefit from already validated cleanrooms, in-house environmental monitoring system as well as training, ancillary services and technical support inclusive of process development and validation. Our cryogenic facilities are available to external clients as off-site storage and offer disaster recovery services as per UK regulatory (HTA) requirements.
Advent Bioservices is currently in the process of applying for licencing and accreditation from UK authorities including the HTA, MHRA and HFEA for the Sawston site.
https://www.sciencedirect.com/science/article/pii/S1465324920303959
Recent NWBO News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/03/2024 08:01:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/13/2024 08:01:24 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2024 09:06:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/08/2024 08:30:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 02:42:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/30/2024 11:49:38 PM
- Biophma Announces Exclusive In License for Dendritic Cell Technology, Sending Shares Higher • AllPennyStocks.com • 06/17/2024 04:40:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 09:11:16 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/03/2024 09:22:55 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
Simple Stock Loans Announces Unique Solutions For Investors Looking for Alternative Liquidity Amidst Recent Small Cap Rally Sep 6, 2024 9:30 AM
Reliant Coffee Debuts at #271 on the Inc. 5000 List of Fastest Growing Companies - Coffee Service Industry Disruptor Brews Up Exponential Growth Sep 5, 2024 11:51 AM
VAYK Confirms Receiving Revenue from First Airbnb Property with 1.4 Million Annual Revenue Goal • VAYK • Sep 4, 2024 9:34 AM
Mawson Finland Limited Expands Known Mineralized Zones at Rajapalot: New Lens Intercepts 21.75 m at 5.25 g/t Gold & 515 ppm Cobalt • MFL • Sep 4, 2024 9:02 AM
Integrated Ventures Acquires 51% Stake In GetTrim.Com (TM), Telemedicine Platform With Focus On Expansion Into Booming GLP-1 Powered Weight Loss Market • INTV • Sep 4, 2024 8:45 AM
Avant Technologies Announces Strategic Review Process Intended to Maximize Shareholder Value • AVAI • Sep 4, 2024 8:00 AM