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What Touchlight's Cell-Free DNA Manufacturing Licence Covers

Touchlight's cell-free DNA manufacturing won a CPHI award, but what do the MHRA certificate and FDA Drug Master File actually say? We read both documents.

By Dr. Eleanor Vance, Regulatory Affairs Editor22 October 20269 min readRegulatory
9 min read

Touchlight, a contract DNA manufacturer based in Hampton, south-west London, won the Innovation Catalyst category at the CPHI Pharma Awards 2026 on 6 October for its platform for cell-free DNA manufacturing. A judging panel decides the prize. It is an industry award and not a regulatory decision, and it concerns a production method, not a medicine.

Behind the award, the regulatory footing sits in 2 public documents, and both say less than the phrases used about them. The MHRA certificate covers DNA made for clinical trials, and the FDA says a Drug Master File is neither approved nor disapproved.

Both documents were read for this article on 13 October 2026, alongside the peer-reviewed studies that compare the company's enzymatic DNA with plasmid DNA. Every one of those studies is pre-clinical, and each was funded at least in part by Touchlight.

One point of vocabulary first. Cell-free here describes how the DNA is made, by enzymes and without bacterial cells, and has nothing to do with the cell-free DNA measured in blood for liquid biopsy. How trial materials are regulated is set out in our piece on the UK clinical trials regulations.

What Touchlight won at the CPHI Pharma Awards 2026

Touchlight won the Innovation Catalyst award, 1 of 15 categories in the CPHI Pharma Awards 2026, for its Doggybone DNA platform, written dbDNA. Informa, which runs the CPHI trade shows, announced the winners at this year's event in Milan. Touchlight says the award was presented at a ceremony there on 6 October 2026.

Shortlisted in 3 categories, according to its own statement of 7 October, the company did not win the other 2. European Pharmaceutical Review's list of winners, published on 8 October, gives Manufacturing Excellence to Anemocyte, for an enzymatic mRNA manufacturing process, and Sustainable Pharma Excellence to Celtic Renewables.

Judging is done on submissions. One of this year's judges, Loic Bishop of the industry group BioPhorum, said the panel had to consider the wider impact each entry could have on patients, partners and the sector.

That list also shows that enzymatic production was a theme of the year and not one company's story. Besides Touchlight and Anemocyte, the Start-up Initiative award went to Primogene for what the list calls a cell-free enzymatic biomanufacturing platform.

In its statement Touchlight repeated 4 claims about its position. It operates 11 GMP manufacturing suites and has had a Drug Master File in place since 2022. In 2025 it received what it calls the world's first GMP licence for cell-free DNA manufacturing. And its DNA has supported 9 accepted investigational new drug and clinical trial applications, with 7 programmes ongoing. Those are company statements. Only 2 of them can be checked against a public record, and the next sections do that.

What the MHRA certificate says

The certificate is public. Its number is UK MIA(IMP) 59193, and anyone can read it on the MHRA's register.

On the register the manufacturer is named as Touchlight DNA Services Limited, at the Morelands Building on Lower Sunbury Road in Hampton, TW12 2ER. According to the agency, the site was inspected under the national inspection programme, most recently on 14 August 2024, and complies with the principles of good manufacturing practice. A date of 21 January 2025 appears on the certificate, a week after the company announced the licence on 14 January.

On 3 points the document narrows the headline, and the first is the legal basis. Part 6 of the Medicines for Human Use (Clinical Trials) Regulations 2004 is the authority it cites, and every operation it lists sits under the heading of human investigational medicinal products. In plain terms, cell-free DNA manufacturing at Hampton is licensed for clinical trial material. Touchlight's January 2025 announcement said as much, describing a manufacturer's authorisation for investigational medicinal products.

Scope comes second. What is described is the enzymatic production of customised DNA sequences for use as active substances in vaccines and therapeutics, or as starting materials for advanced therapy products. It covers non-sterile products, described as low bioburden bulk active substance solutions in small volume liquids, together with batch certification, packaging and quality control testing. Sterile manufacture is not listed.

Then there is the clock. Under the MHRA's own wording, a certificate should not be relied upon to reflect compliance once more than 3 years have passed since the inspection, unless the agency shortens or extends that period. For the Hampton site, 3 years from the inspection is 14 August 2027.

Whether Touchlight was first could not be tested from the register. One certificate cannot show that no other enzymatic DNA maker holds a comparable licence, in the UK or abroad, so the phrase remains Touchlight's own.

A Drug Master File is not an approval

Trade coverage in January 2023 reported that the FDA had signed off Touchlight's Drug Master File.

The FDA's own description of the system is cooler than that. A Drug Master File, the agency says, is a submission used to provide confidential, detailed information about facilities, processes or articles used in making human drugs. Such files are not required by statute or regulation. They "are neither approved nor disapproved". Technical content is reviewed only in connection with an application that refers to the file, such as an investigational new drug application.

Acceptance, the word used in the 2023 reports, therefore cannot mean that the FDA has passed judgement on the process. What the file does for a customer is practical. A developer using the company's DNA as a starting material can point the agency to the file instead of writing that part of its own dossier, and the manufacturer's process details stay confidential.

On dates, the sources do not quite match. Touchlight now says the file has been in place since 2022, while Manufacturing Chemist reported its acceptance on 25 January 2023. Both can be true if the file was submitted in one year and the acceptance announced in the next. Neither source says so.

Similar care is needed with the figure of 9 accepted applications. An accepted investigational new drug application, or a clinical trial application, allows a study to begin. Acceptance is a decision about the trial sponsor's whole dossier, of which the DNA is one component, and it says nothing about whether the product works. Touchlight does not name the 9 programmes in its statement, so the number could not be checked against trial registries.

Enzymatic DNA against plasmid DNA in published studies

Plasmid DNA is grown in bacteria, then extracted and purified. Enzymatic, cell-free DNA manufacturing skips the bacteria.

A 2018 paper in Cancer Immunology, Immunotherapy by Allen and colleagues at the University of Southampton, written with Touchlight staff, describes the method. An enzyme, Phi29 DNA polymerase, copies a template many times over. A second enzyme, protelomerase TelN, cuts and seals the copies into closed linear molecules. What comes out carries the gene of interest, a promoter and a poly A tail, and lacks bacterial sequences such as an antibiotic resistance gene.

On performance, 3 peer-reviewed comparisons were read for this article. All are pre-clinical.

In the Southampton study, mice were vaccinated against 2 cancer-linked proteins from human papillomavirus. Its authors reported that the linear DNA produced similar levels of cellular and antibody immunity to plasmid DNA. Touchlight funded the research, and 6 of the authors were its employees.

A 2019 paper in Gene Therapy, led from University College London, made lentiviral vectors from both kinds of DNA and gave them to newborn mice. Long-term expression of a marker gene was reported as comparable. Touchlight funded the study in part and, the authors say, was involved in all stages of its conduct and analysis.

For a manufacturer the third paper is the most useful, because it reports a difficulty.

In Gene Therapy, in a paper published online in May 2022, Barreira and colleagues at Touchlight wrote that getting high lentiviral titres from the linear DNA had remained a challenge. Linear DNA behaved differently in transfection, so the input amounts and construct ratios had to be reworked, and the vector needed an added termination signal and spacer sequence. With those changes the authors reported infectious titres equivalent to plasmid for 1 CAR-T vector. Touchlight funded the study.

Read together, the papers support a limited statement: in animal and cell experiments, doggybone DNA can do the job plasmid DNA does, after optimisation for the specific product.

None of the abstracts gives a measured comparison of production time, yield or cost, although the 2022 paper asserts that GMP material can be made in a fraction of the time. No human efficacy data were found. PubMed listed 16 papers for the term doggybone DNA on 13 October 2026, and background on the vectors themselves is in our piece on gene therapy vector design and regulation.

Is cell-free DNA manufacturing licensed for commercial medicines

Not on the evidence of the public certificate. Touchlight's MHRA document for the Hampton site covers cell-free DNA manufacturing for investigational medicinal products, meaning material for clinical trials. Making licensed commercial medicines is not listed on it, and no marketed medicine made with this DNA was identified for this article.

That is the normal order of events and not a criticism. A supplier of a starting material follows its customers through development, and the first of them are in early trials. Touchlight's news page describes a Phase 1 trial of a personalised lung cancer vaccine, named NEOVACC, as the first to give a UK patient a product made using its DNA. Phase 1 studies are early-stage and are not evidence of benefit.

Territory matters as well. One is a UK GMP certificate and the other, the Drug Master File, is a US filing. Neither carries over to the other jurisdiction, and neither is a decision of the European Medicines Agency, so a developer planning a trial in the EU would need to establish separately how the material is treated there.

Capacity is the remaining claim. In January 2025 the company said the Hampton facility, completed in 2023, could make more than 8 kilograms of DNA a year, and described that as greater than the current global supply. No independent figure for global supply was found to test it.

What a developer should ask a DNA supplier

An award is not due diligence. Each question below comes straight from the gaps in the public record.

  • Which authorisation covers the material for this product and this trial phase, and in which territory.

  • The date of the last inspection, and when the next is due.

  • Whether the Drug Master File has been referenced in an application the FDA has already reviewed for a comparable product.

  • Comparability data against plasmid DNA for this specific product, including the optimisation it required.

  • Who funded that comparison, and whether anyone outside the supplier has repeated it.

  • Available capacity and lead time, in writing.

What remains unknown is specific. Nothing in the public record shows whether any other maker holds a comparable GMP certificate, which programmes make up the 9 accepted applications, or how the method compares with plasmid on time and cost in independent hands. A list of trial registry numbers from the company would settle the second point. A head-to-head manufacturing study by a group it does not fund would address the third.

For cell-free DNA manufacturing at Hampton, the next fixed date is regulatory. Inspectors last visited on 14 August 2024, so a re-inspection or an extension falls due by 14 August 2027. This article will be reviewed by 13 January 2027, and sooner if the MHRA record changes.

Tags:touchlightdoggybone dnaplasmid dnacphi pharma awardsmhragmp certificatedrug master filegene therapy manufacturingenzymatic dnacdmo

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