{"title":"Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents","authors":"Clara Sanz-Nogués, Timothy O'Brien","doi":"10.1016/j.bbiosy.2021.100018","DOIUrl":"10.1016/j.bbiosy.2021.100018","url":null,"abstract":"<div><p>Producing human mesenchymal stromal cells (MSCs) for clinical use requires adherence to current good manufacturing practice (cGMP) standards. This is necessary for ensuring standardization and reproducibility through the manufacturing process, but also, for product quality and safety. However, the large-scale production of clinical-grade MSCs possesses unique regulatory challenges and hurdles related to the heterogeneous nature of MSC cultures as well as the complex manufacturing process. Following is a compilation of the major issues encountered in the manufacturing of MSCs for clinical use, and our views on the optimal characteristics of the final MSC product.</p></div>","PeriodicalId":72379,"journal":{"name":"Biomaterials and biosystems","volume":"2 ","pages":"Article 100018"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.bbiosy.2021.100018","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9321543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Current interpretations on the in vivo response of bone to additively manufactured metallic porous scaffolds: A review","authors":"Joseph Deering , Kathryn Grandfield","doi":"10.1016/j.bbiosy.2021.100013","DOIUrl":"10.1016/j.bbiosy.2021.100013","url":null,"abstract":"<div><p>Recent advances in the field of metallic additive manufacturing have expanded production capabilities for bone implants to include porous lattice structures. While traditional models of <em>de novo</em> bone formation can be applied to fully dense implant materials, their applicability to the interior of porous materials has not been well-characterized. Unlike other reviews that focus on materials and mechanical properties of lattice structures, this review compiles biological performance from <em>in vivo</em> studies in pre-clinical models only. First, we introduce the most common lattice geometry designs employed <em>in vivo</em> and discuss some of their fabrication advantages and limitations. Then lattice geometry is correlated to quantitative (histomorphometric) and qualitative (histological) assessments of osseointegration. We group studies according to two common implant variables: pore size and percent porosity, and explore the extent of osseointegration using common measures, including bone-implant contact (BIC), bone area (BA), bone volume/total volume (BV/TV) and biomechanical stability, for various animal models and implantation times. Based on this, trends related to <em>in vivo</em> bone formation on the interior of lattice structures are presented. Common challenges with lattice structures are highlighted, including nonuniformity of bone growth through the entirety of the lattice structure due to occlusion effects and avascularity. This review paper identifies a lack of systematic <em>in vivo</em> studies on porous AM implants to target optimum geometric design, including pore shape, size, and percent porosity in controlled animal models and critical-sized defects. Further work focusing on surface modification strategies and systematic geometric studies to homogenize <em>in vivo</em> bone growth through the scaffold interior are recommended to increase implant stability in the early stages of osseointegration.</p></div>","PeriodicalId":72379,"journal":{"name":"Biomaterials and biosystems","volume":"2 ","pages":"Article 100013"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.bbiosy.2021.100013","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9321542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Chemical modification strategies to prepare advanced protein-based biomaterials","authors":"Maria C. Gomes, João F. Mano","doi":"10.1016/j.bbiosy.2021.100010","DOIUrl":"10.1016/j.bbiosy.2021.100010","url":null,"abstract":"<div><p>Nature is a superb source of inspiration when it comes to the development of biomaterials. Proteins, an exquisite asset virtually involved in all biological functions, are envisioned as a biomaterial due to their ability to be chemically modified. Owing to the rich chemical repertoire provided by the side chains and C-/N-terminus present in their backbone, scientists are pursuing chemical ways to upgrade isolated proteins, while maintaining their biological activity or relevant structural properties. By inserting chemical motifs, the crosslinking capability of proteins and capability to attach biochemical and molecular groups can be controlled yielding nano to macro constructs and hydrogels with improved physicochemical and mechanical properties. These cutting-edge approaches elevate the potential use of proteins as promising biomaterials for biotechnology and biomedicine.</p></div>","PeriodicalId":72379,"journal":{"name":"Biomaterials and biosystems","volume":"1 ","pages":"Article 100010"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.bbiosy.2021.100010","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9322012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The convergence of high-tech emerging technologies into the next stage of organ-on-a-chips","authors":"Alessandro Polini , Lorenzo Moroni","doi":"10.1016/j.bbiosy.2021.100012","DOIUrl":"10.1016/j.bbiosy.2021.100012","url":null,"abstract":"<div><p>Recently, organ-on-a-chips (OoCs) have been proposed as highly innovative, truly predictive tools with limitless potential for organ function modelling, drug discovery and testing. By mimicking human key organ functions <em>in vitro</em>, they are proposed as models for studying physiological processes as well as disease-related mechanisms to elucidate pathological pathways and test the safety and efficacy of potential drug candidates, with unprecedented degree of physiological and clinical relevance. Despite the numerous efforts from biology and engineering, we expect that OoC will reach the next level by benefitting from high-tech technologies such as biofabrication, artificial intelligence (AI), robotics and automation.</p></div>","PeriodicalId":72379,"journal":{"name":"Biomaterials and biosystems","volume":"1 ","pages":"Article 100012"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.bbiosy.2021.100012","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9336326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dimitrios Tsiapalis , Stephen Kearns , Jack L. Kelly , Dimitrios I. Zeugolis
{"title":"Growth factor and macromolecular crowding supplementation in human tenocyte culture","authors":"Dimitrios Tsiapalis , Stephen Kearns , Jack L. Kelly , Dimitrios I. Zeugolis","doi":"10.1016/j.bbiosy.2021.100009","DOIUrl":"10.1016/j.bbiosy.2021.100009","url":null,"abstract":"<div><p>Cell-assembled tissue engineering strategies hold great potential in regenerative medicine, as three-dimensional tissue-like modules can be produced, even from a patient's own cells. However, the development of such implantable devices requires prolonged <em>in vitro</em> culture time, which is associated with cell phenotypic drift. Considering that the cells <em>in vivo</em> are subjected to numerous stimuli, multifactorial approaches are continuously gaining pace towards controlling cell fate during <em>in vitro</em> expansion. Herein, we assessed the synergistic effect of simultaneous and serial growth factor supplementation (insulin growth factor-1, platelet-derived growth factor <em>ββ,</em> growth differentiation factor 5 and transforming growth factor <em>β</em>3) to macromolecular crowding (carrageenan) in human tenocyte function; collagen synthesis and deposition; and gene expression. TGF<em>β</em>3 supplementation (without/with carrageenan) induced the highest (among all groups) DNA content. In all cases, tenocyte proliferation was significantly increased as a function of time in culture, whilst metabolic activity was not affected. Carrageenan supplementation induced significantly higher collagen deposition than groups without carrageenan (without/with any growth factor). Of all the growth factors used, TGF<em>β</em>3 induced the highest collagen deposition when used together with carrageenan in both simultaneous and serial fashion. At day 13, gene expression analysis revealed that TGF<em>β</em>3 in serial supplementation to carrageenan upregulated the most and downregulated the least collagen- and tendon- related genes and upregulated the least and downregulated the most osteo-, chondro-, fibrosis- and adipose- related trans-differentiation genes. Collectively, these data clearly advocate the beneficial effects of multifactorial approaches (in this case, growth factor and macromolecular crowding supplementation) in the development of functional cell-assembled tissue surrogates.</p></div>","PeriodicalId":72379,"journal":{"name":"Biomaterials and biosystems","volume":"1 ","pages":"Article 100009"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.bbiosy.2021.100009","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9336328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Devon J. Crouch , Carl M. Sheridan , Raechelle A. D'Sa , Colin E. Willoughby , Lucy A. Bosworth
{"title":"Exploiting biomaterial approaches to manufacture an artificial trabecular meshwork: A progress report","authors":"Devon J. Crouch , Carl M. Sheridan , Raechelle A. D'Sa , Colin E. Willoughby , Lucy A. Bosworth","doi":"10.1016/j.bbiosy.2021.100011","DOIUrl":"10.1016/j.bbiosy.2021.100011","url":null,"abstract":"<div><p>Glaucoma is the second leading cause of irreversible blindness worldwide. Glaucoma is a progressive optic neuropathy in which permanent loss of peripheral vision results from neurodegeneration in the optic nerve head. The trabecular meshwork is responsible for regulating intraocular pressure, which to date, is the only modifiable risk factor associated with the development of glaucoma. Lowering intraocular pressure reduces glaucoma progression and current surgical approaches for glaucoma attempt to reduce outflow resistance through the trabecular meshwork. Many surgical approaches use minimally invasive glaucoma surgeries (MIGS) to control glaucoma. In this progress report, biomaterials currently employed to treat glaucoma, such as MIGS, and the issues associated with them are described. The report also discusses innovative biofabrication approaches that aim to revolutionise glaucoma treatment through tissue engineering and regenerative medicine (TERM). At present, there are very few applications targeted towards TM engineering <em>in vivo</em>, with a great proportion of these biomaterial structures being developed for <em>in vitro</em> model use. This is a consequence of the many anatomical and physiological attributes that must be considered when designing a TERM device for microscopic tissues, such as the trabecular meshwork. Ongoing advancements in TERM research from multi-disciplinary teams should lead to the development of a state-of-the-art device to restore trabecular meshwork function and provide a bio-engineering solution to improve patient outcomes.</p></div>","PeriodicalId":72379,"journal":{"name":"Biomaterials and biosystems","volume":"1 ","pages":"Article 100011"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.bbiosy.2021.100011","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9322014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Granular hydrogels for endogenous tissue repair","authors":"Taimoor H. Qazi, Jason A. Burdick","doi":"10.1016/j.bbiosy.2021.100008","DOIUrl":"10.1016/j.bbiosy.2021.100008","url":null,"abstract":"<div><p>Granular hydrogels, formed by the packing of hydrogel microparticles (microgels), are emerging to support the endogenous repair of injured tissues by guiding local cell behavior. In contrast to traditional pre-formed scaffolds and bulk hydrogels, granular hydrogels offer exciting features such as injectability, inherent porosity, and the potential delivery of biologics. Further, granular hydrogel design allows for the tuning of constituent microgel properties and the mixing of discrete microgel populations. This modularity allows the creation of multifunctional granular hydrogels that promote cell recruitment, guide extracellular matrix deposition, and stimulate tissue growth to drive endogenous repair.</p></div>","PeriodicalId":72379,"journal":{"name":"Biomaterials and biosystems","volume":"1 ","pages":"Article 100008"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.bbiosy.2021.100008","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9336327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}