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By Caroline Copley
BERLIN, Aug 19 (Reuters) - German contract drug manufacturer
Rentschler Biopharma is in final preparations to start
commercial production of CureVac's COVID-19 vaccine,
its chief executive said, despite uncertainty over whether the
shot will gain European Union approval.
Based in Laupheim in southern Germany, Rentschler has built
a dedicated production suite for CureVac's vaccine with a team
of 45 dedicated employees and is still planning to deliver more
than 100 million doses per year.
"It looks like CureVac wants us to proceed," CEO Frank
Mathias told Reuters in an interview, adding there were weekly
steering meetings between the two companies to fine-tune the
start of the production process.
CureVac said last month its COVID-19 vaccine was 48%
effective in the final analysis of a pivotal mass trial, casting
doubt over its future use.
The European Medicines Agency (EMA) is still yet to approve
the shot. CureVac previously said that the regulatory hurdle was
50% efficacy in principle, but that various other considerations
could come into play.
In a worst-case scenario, it would take between three to six
months to retool the production suite to make other products.
But Mathias was confident the production process could be
easily adapted to make CureVac's "second-generation" COVID-19
vaccine, which it is developing together with GlaxoSmithKline
and has shown promise in a monkey trial.
"I expect the production process to be very similar. It
would require new mRNA code, plus the need to get the process
approved by regulatory authorities," he said.
Rentschler also purifies and concentrates the drug substance
for the COVID-19 shot jointly marketed by Pfizer and
BioNTech. It has processed 100 batches of mRNA over
the last 11 months, equivalent to 700 million doses of vaccine.
The company believes it will be involved in mRNA production
for the foreseeable future as the technology is also being
developed to treat cancer, although the quantities needed may be
smaller.
Around 20% of its production is taken up with mRNA while the
remainder is focused on highly complex medicines and their
components.
(Reporting by Caroline Copley; Editing by Douglas Busvine and
Jan Harvey)
