Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access

Abstract

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Advanced pharmaceutical manufacturing: A functional definition

“…The authors recognize that companies are often hesitant to invest in APM, concerned that regulatory authorities are not ready to accept the proposed changes, while the regulators wait for concrete data of product safety, efficacy, and quality. [ 74 ] Even though regulators across the globe have largely encouraged continuous manufacturing technology and APM, it is recognized that real or perceived hurdles may exist. [ 75 ] In spite of this perception a recent FDA internal audit found that products with CM processes tended to be approved in less time and reach the market sooner.…”

Development of a continuous synthesis process for carbamazepine using validated in-line Raman spectroscopy and kinetic modelling for disturbance simulation

“…Advanced manufacturing technologies such as CM can also help improve domestic manufacturing capabilities, thus alleviating to some degree the constraints from global supply chains. 4 Currently, batch manufacturing is still the most widely utilized production method by the pharmaceutical industry. The transition from batch to CM in the pharmaceutical industry is in its early stage and therefore presents unique challenges.…”

Point-of-Care Peptide Hormone Production Enabled by Cell-Free Protein Synthesis

“…Taken together, the current approach for biomanufacturing peptide and protein therapeutics can limit response time, distribution of medicines, and drive healthcare inequities. This backdrop sets the stage to reimagine drug manufacturing away from current reliance on centralized facilities. ,, …”

“…This backdrop sets the stage to reimagine drug manufacturing away from current reliance on centralized facilities. 8,10,11 Cell-free protein synthesis (CFPS) has recently emerged as one potential way to rethink decentralized drug manufacturing. CFPS is a technology that harnesses the transcription and translation machinery from cells, without using living intact cells, to produce peptides and proteins in vitro.…”