Speciality Chemicals Magazine SEPT / OCT 2022 | Page 27

PHARMACEUTICALS
Overcoming the capacity crunch
The simplest solution to the capacity crunch is to build more reactors . CDMOs have recognised the need for more API production and have taken steps to increase capacity . From Aceto to Lonza to SK Pharmteco , companies have announced expansions opening in 2022 to relieve a tight API supply chain , but more is needed . Since it will take years for additional GMP capacity to come online , industry must use a number of mitigation strategies to help stretch current capacity further . With capacity issues likely remaining a challenge for the foreseeable future , finding ways to work smarter with what is available , both in terms of reactor capacity and within the supply chain , should receive extra emphasis .
To deepen their programme knowledge via R & D , drug innovator companies can have CDMOs develop novel routes , innovative methods to optimise chemistry and shorten reaction sequences for more efficient production of NMEs . These new methods may also simplify the raw material requirements for a project , which could potentially mitigate issues with sourcing raw materials . Together , these process improvements can help shrink the anticipated time to manufacture the API , fit projects into increasingly constricted manufacturing windows , and may even enable the manufacturing to be completed on smallercapacity equipment . Even with these production innovations aimed getting more out of less , it is still important to have a focus on optimising supply chains . To help
ensure that production is not halted due to delays in sourcing , CDMOs should be experienced , geographically diversified companies with buttoneddown logistics , and the capacity to source raw materials and tap additional resources to manufacture needed raw materials . In the end , one of the most important factors for squeezing out extra capacity and maintaining timelines is having honest communication between trusting teams . When new drug innovators and CDMOs have good , open lines of communication , issues can be raised and discussed in a straightforward and clear fashion that allows for the discovery of a variety of potential solutions . When innovators and CDMOs have teams with trust as a primary component , it allows for the efficient and confident implementation of solutions . •
References : 1 : BCC Research , Biologic Therapeutic Drugs : Technologies & Global Markets , April 2021
2 : T . C . M . Nogueira & M . V . N . de Souza , Bioorganic & Medicinal Chemistry , 2021 , 46 , 116340 , ISSN 0968-0896 , https :// doi . org / 10.1016 / j . bmc . 2021.116340 : https :// www . sciencedirect . com / science / article / pii / S0968089621003485
3 : A . Mullard , 2020 FDA Drug Approvals , Nature Reviews , February 2021 , 20 , pp85-90 : Nature . com / nrd 4 : Clinical Development Success Rates & Contributing Factors 2011-2020 : https :// pharmaintelligence . informa . com
Scott Mohler
DIRECTOR , BUSINESS DEVELOPMENT
ACETO k + 1 541 357 7243 J smohler @ aceto . com j www . aceto . com
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