In this week’s news, UK cell therapy capacity soars, EMA calls for input on API impurities quantification, BIO wants more info on FDA draft gene therapy guidelines and more…
UK ups cell therapy production capacity 60%
UK GMP manufacturing capacity has increased 60% since 2017 according to analysis by the Cell and Gene Therapy Catapult.
The Government backed organisation shared details in a report published last week. It said the GMP capacity hike was prompted increased interest in developing cell therapies.
It cited its own GMP centre in Stevenage, as well as expansion of facilities owned by Cobra Biologics and the Scottish National Blood Transfusion Service as examples of recent investment.
The organisation also revealed that capacity utilisation has increased from 77% last year to 81% at present.
It said, “The continuing high utilisation of these centres is indicative of a continuously increasing demand for cell and gene therapy services and infrastructure driven by the rapidly evolving pipeline of advanced therapies.
EMA looks at non-genotoxic impurities in APIs
The EMA has drafted a reflection paper on the qualification of non-genotoxic impurities in drugs ingredients.
The paper – available here – is designed to prompt discussion about how NGIs – which as their name suggests are impurities resulting from the chemical reactions involved in API production – should be measured.
The agency wrote, “Qualification of NGI may be required when data from the regular (non-)clinical development with the API batches is not considered sufficient.
“The aim of this paper is to complement currently available guidelines addressing qualification of NGI such as ICH Q3A and ICH Q3B. The reflection paper discusses different non-animal approaches, which may provide more compound-specific information than animal studies with API batches containing the impurities at low levels.”
BIO wants clarification on US FDA gene therapy guidelines
US Industry group BIO wants the US FDA to clarify draft guidelines covering the development and production of gene therapies.
The industry group commented separately on a number of topics, including long-term follow up and chemistry, manufacturing and controls requirements related to gene-therapy products.
On the latter subject BIO says, “The Draft Guidance is quite prescriptive and does not necessarily match modern manufacturing. BIO would like to see a better balance between the information that FDA needs to see in order to allow an IND to move forward and over-reporting of information that may be unnecessary.
“On the whole it seems that much of the information required in the Draft Guidance is more appropriate for a BLA filing, an approved product, or post approval changes to a product rather than an IND.”
ICH provides harmonization progress report
The International Council for Harmonisation (ICH) published a progress report on its ongoing efforts to harmonize regulations and standards which apply to pharmaceutical production.
The document – which covers topics discussed at a meeting in Charlotte last month – updates on efforts to make the organisation more global, which began in 2015.
“Three years on from the reform of ICH, all organizational changes have been implemented,” the ICH wrote. It cited the fact its membership has grown to include 16 members and 28 observers in the period.
Also in the news
Reports suggest the Indian Government plants to legally mandate that manufacturers and importers of faulty medical devices pay compensation to affected patients. Read more at Moneycontrol.
The Indian Government is also planning to begin regulating online pharmacies according to a Livemint report. The regulation is expected to come into force by December.
NHS England plans to make Merck & Co’s immunotherapy Keytruda (Pembrolizumab) available to skin cancer patients. Read more at Cancer Research UK.
EU Court says Italy’s decision to reimburse Roche’s reformulated Avastin for off-label use in wet AMD is not contrary to EU law, and no new marketing or manufacturing authorization is needed. See the full ruling here.
The Irish Times looked at the impact Brexit-induced delays will have on the delivery of medical supplies.