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While great effort is being placed on reducing disease burdens in Africa, the circulation of falsified and substandard medicines in the continent are reversing the hard-won gains. This commentary provides insights on the high (and increasing) burden, impact and threat that falsified and substandard medicines pose to the region's development. The proposed recommendations, such as a coherent multi-sectorial and government-led strategy, call for a fundamental rethink of approaches towards strong regulations, policies, legislations, community-based approaches, collaborations and investments, which all must be scaled up before this the situation gets out of control. These recommendations are of paramount importance and have the potential to ensure access to genuine medicines and also to avert therapeutic failure and intoxication from dangerous substances. In addition, there will be added benefits to the economic, social, health and well-being of the region. Concerted efforts towards medicine regulations have enormous potential to contribute towards averting many preventable deaths and reducing disease burden in the region. A paradigm shift is necessary to ensure quality medicines reach patients at community and healthcare facilities to prevent this silent epidemic in Africa., Competing Interests: None declared., (© 2022 Published by Elsevier Ltd on behalf of The Royal Society for Public Health.)

The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure on manufacturers to produce at lower cost. Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly due to concerns related to cost and scale-up. This review summarizes how a single-use holistic process and facility strategy can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics. Technologies enabling high productivity, right-sized, small footprint, continuous, and automated upstream and downstream operations are evaluated in order to propose a concept for the flexible facility of the future.

Collagenases are critical reagents determining yield and quality of isolated human pancreatic islets and may affect islet transplantation outcome. Some islet transplantation centers have compared 2 or more collagenase blends; however, the results regarding differences in quantity and quality of islets are conflicting. Thus, for the first time, a mixed treatment comparison (MTC) meta-analysis was carried out to compile data about the effect of different collagenases used for human pancreas digestion on islet yield, purity, viability and stimulation index (SI). Pubmed, Embase and Cochrane libraries were searched. Of 755 articles retrieved, a total of 15 articles fulfilled the eligibility criteria and were included in the MTC meta-analysis. Our results revealed that Vitacyte and Liberase MTF were associated with a small increase in islet yield (islet equivalent number/g pancreas) when compared with Sevac enzyme [standardized mean difference (95% credible interval - CrI) = -2.19 (-4.25 to -0.21) and -2.28 (-4.49 to -0.23), respectively]. However, all other enzyme comparisons did not show any significant difference regarding islet yield. Purity and viability percentages were not significantly different among any of the analyzed digestion enzymes. Interestingly, Vitacyte and Serva NB1 were associated with increased SI when compared with Liberase MTF enzyme [unstandardized weighted mean difference (95% CrI) = -1.69 (-2.87 to -0.51) and -1.07 (-1.79 to -0.39), respectively]. In conclusion, our MTC meta-analysis suggests that the digestion enzymes currently being used for islet isolation works with similar efficiency regarding islet yield, purity and viability; however, Vitacyte and Serva NB1 enzymes seem to be associated with an improved SI as compared with Liberase MTF.