The Economist - UK (2022-02-19)

74 Science & technology The Economist February 19th 2022

Drugmanufacturing

Cloning vaccine factories

A

t theheartofitssiteinMarburg,Ger­

many,BioNTechisputtingthefinish­

ingtouchesona newkindoffactory.The

drugcompanyhasspenteightmonthsre­

working its manufacturingprocesses to

produceitsmrnacovid­19vaccineinsidea

set ofstandard shipping containers. By

creating a modular approach to drug

manufacturing, Ugur Sahin, BioNTech’s

boss,saysheaimstotransformmedicine

productionaroundtheworld.

Theworkisanalogoustosoftwarede­

velopersrewritingtheircodetorunondif­

ferentkindsofcomputer—portinga game

fromMicrosoft’sXboxsothatit willrunon

a SonyPlayStation,forexample.Biological

portinginvolvestweakingthe50,000steps

thatcomprisethemanufacturingprocess

ofthemrnavaccinefromoneenviron­

ment, BioNTech’s existing production

linesaroundtheworld,sothattheywork

inanother,a seriesofconnected,standard

metalshippingcontainers.Thefirmplans

tosenditscontainerisedmrnafactories—

whichitcallsBiontainers—topartsofthe

worldwhichlacktheirownvaccine­manu­

facturingcapabilities.Thefirstwillarrive

inanAfricancountry,notyetnamed,to­

wardstheendof2022.

BioNTechhasturnedtocontainersasa

reliable,repeatablewaytoachieve“good

manufacturingpractice”(gmp), a pharma­

ceutical­industrytermfortheminimum

standardsrequired ofamanufactureras

partoftheirauthorisationtosellproducts.

gmpstandardsexistinordertoensurea

consistentlyhighqualityofmanufactur­

ingoutput,which inturnprotects con­

sumersfrombadlymadedrugs.Validating

newgmpfacilitiesisa long,slowprocess.

MrSahin’saimistoremove,tosomeex­

tent,localfactorsfromtheequationthat

governswherevaccinescanbeproduced,

witha modulargmpfacilitythatcanbein­

stalledandrunanywhereintheworld.

Allmanufacturing operationsconsist

ofa seriesofstepsthatareknownintheir

entiretyonlytothecollectionofengineers

whocarryoutthework,a sortofindustrial

recipe. Thisknowledgeabouttheproduc­

tionprocessincludeseverythingfromthe

settingsofdialsoneverydevicetothetem­

peratures,pressuresandtimingsatwhich

chemicalreactionsshouldrun.Thesevari­

ablesareprecisetotheextentthattheycan

change depending on the weather. The

transferofthisrecipetonewproduction

facilities presents perhaps the greatest

bottlenecktoincreasingvaccineproduc­

tion.Evenwhenpharmaceuticalcompa­

niesweretransferringthisknowledgein­

ternally,duringtheheightofthepandem­

ic,ittookaroundeightmonthstoincrease

theirownvaccine­productioncapacity.

MrSahinwantshisshippingcontainers

tospeedthingsup.Hisideaisthatafterthe

processknowledgehasbeensuccessfully

portedintothestandardisedenvironment

oftheshippingcontaineronce,thatfacili­

tycanthenbequicklyclonedintoother

containers. Updates to the production

methodortweakstotherecipeofthevac­

cineitselfcouldbetransmitteddigitally to

anycontainersinthenetwork.“This”,says

MrSahin,“isthefutureofmanufacturing

notonlyforAfrica,butworldwide.”

Faster,moreproductive

Aftereightmonthsofworktogetitsfirst

containerfactoryoffthegroundinMar­

burg,BioNTech’sapproachwillbeputto

thetestlaterthisyear.BytheendofJune,

MrSahinsays,thesiteatitspartnercoun­

tryinAfricawillbepreparedforthearrival

ofthecontainers—BioNTechisindiscus­

sionswithSouthAfrica,RwandaandSene­

gal. Heexpectsthecontainers,theinteri­

orsofwhichwillhavebeensetuptothe

letterinGermany,tohavearrivedbythe

endof2022.Eachsetof 12 containerswill

needfourorfiveoperatorsandbecapable

ofproducingsome40m­60mdosesevery

year.BioNTechhopesthefacilitywillcost

“significantly  less”  than  a  traditional  vac­

cine  manufacturing  factory  of  equivalent

output, which comes with a price tag of at

least $170m.

The  validation  and  quality­control

work  will  carry  on  through  2023,  as  will

hiring and training local operators. In par­

allel, there will be conversations with reg­

ulators  about  the  new  containerised  pro­

duction  process.  Mr  Sahin  says  BioNTech

is  already  talking  to  the  African  Union,  a

regional  bloc,  the  Africa  Centres  for  Dis­

ease  Control  and  Prevention  and  national

regulators. He hopes that the German and

European gmpstandards to which the con­

tainer factories have been built will be ac­

ceptable. If they are, then vaccine produc­

tion will start at the end of 2023.

Although  BioNTech’s  plan  will  not  see

any  production  facilities  in  operation  for

almost two years, it also plans for the Bion­

tainers to have utility beyond the pandem­

ic and the production of covid­19 vaccines.

Mr Sahin says the production system could

be used to make other vaccines and drugs,

for example, against malaria or tuberculo­

sis.  In  July  last  year  BioNTech  announced

its  aim  “to  develop  a  well­tolerated  and

highly  effective  malaria  vaccine  and  im­

plement  sustainable  vaccine  supply  sol­

utions on the African continent”.

There may yet be pitfalls in BioNTech’s

plan. Containers may prove to offer a less

uniform  manufacturing  environment

than Mr Sahin hopes. Regulators may spot

issues.  Countries  around  the  world  may

not  accept  medicines  produced  in  facili­

ties  which,  although  geographically  local,

are  operationally  under  a  foreign  com­

pany’s control. But the principle of reduc­

ing the cost of copying process knowledge

is sound. If it works, Mr Sahin is likely not

just  to  boost  manufacturingcapacity  on

the  African  continent,  but  tochange  the

way drugs are made everywhere.n

BioNTech wants to use shipping containers as standardised vaccine factories

to expand capacity worldwide

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