You are correct that Advent was a contract manufacturer licensed to perform such services either through contract, via subcontract, or directly in another facility that they apparently leased access to in London. I am pretty certain that they do the work directly, whether under another firms “license” and via contract or however Cognate originally made that facility available to its subsidiary that has no GMP certified facilities of its own in the UK.
At that facility, they manufactured and still apparently manufacture DCVax-L on a compassionate use basis.
From the most recent financials a bit more about the relationship:
On May 14, 2018, the Company entered into a DCVax®-L Manufacturing and Services Agreement (“MSA”) with Advent BioServices, a related party which was formerly part of Cognate BioServices and was spun off separately as part of an institutional financing of Cognate. The Advent Agreement provides for manufacturing of DCVax-L products at an existing facility in London. The Agreement is structured in the same manner as the Company’s prior agreements with Cognate BioServices. The Advent Agreement provides for certain payments for achievement of milestones and, as was the case under the prior agreement with Cognate BioServices, the Company is required to pay certain fees for dedicated production capacity for DCVax production, and pay for manufacturing of DCVax-L products for a certain minimum number of patients, whether or not the Company fully utilizes the dedicated capacity and number of patients. Either party may terminate the MSA on 12 months’ notice, to allow for transition arrangements by both parties.
19 Table of Contents
NORTHWEST BIOTHERAPEUTICS, INC. NOTES TO CONDENSED CONSOLIDATED STATEMENTS
On November 8, 2019, the Company and Advent entered into an Ancillary Services Agreement with an 8-month Term for U.K. Facility Development Activities and Compassionate Use Program Activities. The Ancillary Services Agreement establishes a structure under which Advent develops Statements of Work (“SOWs”) for the U.K. Facility Development Activities and Compassionate Use Program Activities, and delivers those SOWs to the Company for review and approval. After an SOW is approved by the Company, Advent will proceed with or continue the applicable services and will invoice the Company pursuant to the SOW. Since both the U.K. Facility Development and the Compassionate Use Program involve pioneering and uncertainties in most aspects, the invoicing under the Ancillary Services Agreement is on the basis of costs incurred plus fifteen percent. The Ancillary Services Agreement had an original term of eight months, which ended in July 2020. The Company extended the term by 12 months to July 2021, with no other changes, and recently extended it for another 12 months to July 2022.”
Also:
“ 8. Related Party Transactions
Advent BioServices Agreement
The Company has a Manufacturing Services Agreement with Advent BioServices (“Advent”) for the manufacture of DCVax-L products at an existing facility in London, as previously reported. The Company also has an Ancillary Services Agreement with Advent, which establishes a structure under which Advent submits Statements of Work (“SOWs”) for activities related to the development of the Sawston facility and the compassionate use activities in the UK, as previously reported. The Ancillary Services Agreement had an original term of eight months, which ended in July 2020. The Company extended the initial term by 12 months to July 2021, with no other changes, and recently extended the term for another 12 months to July 2022.
Related Party Expenses and Accounts Payable
During the three months ended September 30, 2021 and 2020, the Company recognized approximately $1.7 million and $1.4 million, respectively, in research and development costs from Advent. During the nine months ended September 30, 2021 and 2020, the Company recognized approximately $5.1 million and $4.2 million, respectively, in research and development costs from Advent.
Additionally, during the nine months ended September 30, 2021 and 2020, the Company capitalized $2.3 million and $1.3 million costs, invoiced by Advent, related to the Sawston buildout. Some of these amounts have been paid and some have not been paid.”
Northwest Biotherapeutics Announces MHRA Approval Of License for GMP Manufacturing At Sawston, UK Facility BETHESDA, Md., December 21, 2021 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that approval has been received from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility.
The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London. The license also permits the import and GMP manufacture of other cell therapy products under the UK’s supply of unlicensed medicinal products (‘Specials’) regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme.
The Company is developing the Sawston facility in phases, both to optimize the timing of capital requirements and to enable each phase to be state of the art when developed, as manufacturing technologies are advancing significantly in the field of cell therapies. To date, the Company has developed Phase 1A of the facility, comprising approximately 4,400 square feet of the overall 88,345 square feet. The Company anticipates that Phase 1A alone will be able to manufacture DCVax-L products for 45-50 patients per month, or 450-500 patients per year – a significant increase from the current manufacturing capacity of four to six patients per month which, to date, has been taking place in a GMP clean room facility in London, UK.
This MHRA license is a culmination of intensive preparations that have been underway for much of 2021. The process included an extensive application process, a week-long inspection of all aspects of the physical facility, its construction and equipment, all aspects of the facility’s operations, including all operating systems, flow of materials and activities, sterility, quality control, staff and other factors, and all of the regulatory documentation, including standard operating procedures (SOPs) for the facility and for the product, batch manufacturing records, data from practice manufacturing runs and other required documents.
This MHRA license follows the license approval by the UK’s Human Tissue Authority (HTA) in October. That license covers the collection, processing and storage of human tissue and cells for medical purposes, including cell therapies such as DCVax-L. The preparatory work and applications for the MHRA and HTA licenses have been carried out by Advent Bioservices, NWBio’s UK entity contract manufacturer, operator, and license holder.
Advent is the facility manager by contract with NWBO, and all manufacturing in this facility is by the approval or license / contractual agreement if NWBO, because the facility is ultimately controlled and owned by NWBO. If NEBO decided to manufacture itself, if they were bought and the buyer decided to do so, the parties under contract have to work for a year to transfer the license to NWBO.
Have you ever seen a food making facility? They too are regulated. When you buy a company with one of those, also all the licenses travel to the purchaser, but the purchaser still has to run the facility in a manner consistent with receiving and maintaining all certifications and/or licenses.
Sub-contracting is not a new idea, just something that certain posters either are sincerely confused by, or unfamiliar with, and some might even simply find it a convenient topic of confusion.
AI
