A pediatric dosage form for crizotinib (Xalkori) was commercialized using quality-by-design principles in a material-sparing fashion. The dosage form consists of spherical multiparticulates (microspheres or pellets) that are coated and encapsulated in capsules for opening. The crizotinib (Xalkori)-coated pellet product is approved in the US for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) and unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. The product is also approved in the US for adult patients with non-small cell lung cancer (NSCLC) who are unable to swallow intact capsules. The lipid multiparticulate is composed of a lipid matrix, a dissolution enhancer, and an active pharmaceutical ingredient (API). The API, which remains crystalline, is embedded within the microsphere at a 60% drug loading in the uncoated lipid multiparticulate to enable dose flexibility. The melt spray congealing technique using a rotary atomizer is used to manufacture the lipid multiparticulate. Following melt spray congealing, a barrier coating is applied via fluid bed coating. Due to their particle size and content uniformity, this dosage form provides the dosing flexibility and swallowability needed for the pediatric population. The required pediatric dose is achieved by opening the capsules and combining doses of different encapsulated dose strengths, followed by administration of the multiparticulates directly to the mouth. The encapsulation process was optimized through equipment modifications and by using a design of experiments approach to understand the operating space. A limited number of development batches produced using commercial-scale equipment were leveraged to design, understand, and verify the manufacturing process space. The quality by design and material-sparing approach taken to design the melt spray congeal and encapsulation manufacturing processes resulted in a pediatric product with exceptional content uniformity (a 95% confidence and 99% probability of passing USP <905> content uniformity testing for future batches).

Since the Artificial Intelligence Committee of the American Society of Retina Specialists developed the initial task force report in 2020, the artificial intelligence (AI) field has seen further adoption of US Food and Drug Administration-approved AI platforms and significant development of AI for various retinal conditions. With expansion of this technology comes further areas of challenges, including the data sources used in AI, the democracy of AI, commercialization, bias, and the need for provider education on the technology of AI. The overall focus of this committee report is to explore these recent issues as they relate to the continued development of AI and its integration into ophthalmology and retinal practice.

The use of endophytic microbes is increasing in commercial agriculture. This review will begin with a strain selection. Most strains will not function well, so only a few provide adequate performance. It will also describe the endophyte-plant relationship and the fungi and bacteria involved. Their abilities to alleviate biotic (diseases and pests) and abiotic stresses (drought, salt, and flooding) to remediate pollution and increase photosynthetic capabilities will be described. Their mechanisms of action will be elucidated. These frequently result in increased plant yields. Finally, methods and practices for formulation and commercial use will be described.

At the International Symposium on Biodegradable Polymers (ISBP2022) in Sion, Switzerland, experts from academia and industry underscored the remarkable progress in biobased and biodegradable polymers (BBPs) since their initial commercialization around 50 years ago. Despite significant advancements, the technology readiness level (TRL), market adoption, and industrialization of BBPs is not yet competitive to conventional plastics. In this perspective, we summarize the challenges and requirements for advancing the development and industrialization of BBPs, drawing insights from international experts coming from academia and industry, who had participated in the survey and podium discussion during the ISBP2022. In fact, BBPs grapple with persistent and emerging challenges throughout the value chain. These challenges can be grouped into four areas and involve i) the pursuit of sustainable feedstocks together with efficient production and downstream processes as well as recycling technologies and infrastructure; ii) meeting or revisiting product requirements by industry, markets, and consumers; iii) navigating a non-level playing field in their sustainability assessment (LCA) compared to conventional plastics; and iv) struggling with underdeveloped and partially biased policy and financial frameworks as well as lacking clear definitions, terminologies and communication.

UNASSIGNED: Donor human milk is recommended when infants are unable to be fed their mother\'s own milk or require supplementation. For-profit companies use technologies to create human milk products for infants in the neonatal intensive care setting without consistent guidelines and regulatory frameworks in place. This commercialization of human milk is inadequately conceptualized and ill-defined.
UNASSIGNED: The aim of this study is to conceptualize and define the commercialization of human milk and discuss the need for policy guidelines and regulations.
UNASSIGNED: Using a concept analysis framework, we reviewed the literature on the commercialization of human milk, analyzed the antecedents and potential consequences of the industry, and developed a conceptual definition. The literature review resulted in 13 relevant articles.
UNASSIGNED: There has been a surge in the development and availability of human milk products for vulnerable infants developed by for-profit companies. Commercialized human milk can be defined as the packaging and sale of human milk and human milk components for financial gain. Factors contributing to the commercialization of human milk include an increased demand for human milk, and consequences include potential undermining of breastfeeding. The lack of guidelines and regulations raises concerns of equity, ethics, and safety.
UNASSIGNED: The industry is rapidly growing, resulting in an urgent need for consistent guidelines and regulatory frameworks. If left unaddressed, there could be potential risks for donor milk banking, the future of breastfeeding, and infant and maternal health.

Nanotherapeutics have gained significant attention for the treatment of numerous cancers, primarily because they can accumulate in and/or selectively target tumors leading to improved pharmacodynamics of encapsulated drugs. The flexibility to engineer the nanotherapeutic characteristics including size, morphology, drug release profiles, and surface properties make nanotherapeutics a unique platform for cancer drug formulation. Polymeric nanotherapeutics including micelles and dendrimers represent a large number of formulation strategies developed over the last decade. However, compared to liposomes and lipid-based nanotherapeutics, polymeric nanotherapeutics have had limited clinical translation from the laboratory. One of the key limitations of polymeric nanotherapeutics formulations for clinical translation has been the reproducibility in preparing consistent and homogeneous large-scale batches. In this review, we describe polymeric nanotherapeutics and discuss the most common laboratory and scale-up formulation methods, specifically those proposed for clinical cancer therapies. We also provide an overview of the major challenges and opportunities for scaling polymeric nanotherapeutics to clinical-grade formulations. Finally, we will review the regulatory requirements and challenges in advancing nanotherapeutics to the clinic.

Technology transfer (TT) is a necessary, yet complex process to convey and disseminate scientific knowledge to the commercial sector. However, multiple barriers in TT can impede commercialization and innovative progress. To cultivate a deeper understanding, we conducted five interviews with strategic, elite leaders in different areas of TT in the United States. Experts shared their perspectives on the current state of TT, what needs improvement, and potential solutions to enhance the TT landscape, with a focus on biotechnology and medical devices. The formation of strong management teams, a comprehension of the regulatory, reimbursement, and funding pathways and policies, and thorough market assessments were noted as key aspects for venture success. Collaboration with Technology Transfer Offices (TTOs), industry experts, and strategic partners are also essential to support academic innovators and guide them throughout the complex commercialization process. There is agreement that a venture should have a defined vision and clear goals with a robust business case for the innovation; early involvement of TTOs is essential. Comprehension of the complexities and key facets of TT, while also streamlining the process, will better position biomedical innovators for success.

The introduction of exotic breeds and the cultivation of new lines by breeding companies have posed challenges to native chickens in South China, including loss of breed characteristics, decreased genetic diversity, and declining purity. Understanding the population genetic structure and genetic diversity of native chickens in South China is crucial for further advancements in breeding efforts. In this study, we analyzed the population genetic structure and genetic diversity of 321 individuals from 10 different breeds in South China. By comparing commercial chickens with native ones, we identified selection signatures occurring between local chickens and commercial breeds. The analysis of population genetic structure revealed that the native chicken populations in South China exhibited a considerable level of genetic diversity. Moreover, the commercial lines of Xiaobai chicken and Huangma chicken displayed even higher levels of genetic diversity, which distinguished them from other native varieties at the clustering level. However, certain individuals within these commercial varieties showed a discernible genetic relationship with the native populations. Notably, both commercial varieties also retained a significant degree of genetic similarity to their respective native counterparts. In order to investigate the genomic changes occurring during the commercialization of native chickens, we employed 4 methods (Fst, ROD, XPCLR, and XPEHH) to identify potential candidate regions displaying selective signatures in Southern Chinese native chicken population. A total of 168 (identified by Fst and ROD) and 86 (identified by XPCLR and XPEHH) overlapping genes were discovered. Functional annotation analysis revealed that these genes may be associated with reproduction and growth (SAMSN1, HYLS1, ROBO3, FGF14, PRSS23), musculoskeletal development (DNER, MYBPC1, DGKB, ORC1, KLF10), disease resistance and environmental adaptability (PUS3, CRB2, CALD1, USP15, SGCD, LTBP1), as well as egg production (ADGRB3, ACSF3). Overall, native chickens in South China harbor numerous selective sweep regions compared to commercial chickens, enriching valuable genomic resources for future genetic research and breeding conservation.

Solid-state batteries are commonly acknowledged as the forthcoming evolution in energy storage technologies. Recent development progress for these rechargeable batteries has notably accelerated their trajectory toward achieving commercial feasibility. In particular, all-solid-state lithium-sulfur batteries (ASSLSBs) that rely on lithium-sulfur reversible redox processes exhibit immense potential as an energy storage system, surpassing conventional lithium-ion batteries. This can be attributed predominantly to their exceptional energy density, extended operational lifespan, and heightened safety attributes. Despite these advantages, the adoption of ASSLSBs in the commercial sector has been sluggish. To expedite research and development in this particular area, this article provides a thorough review of the current state of ASSLSBs. We delve into an in-depth analysis of the rationale behind transitioning to ASSLSBs, explore the fundamental scientific principles involved, and provide a comprehensive evaluation of the main challenges faced by ASSLSBs. We suggest that future research in this field should prioritize plummeting the presence of inactive substances, adopting electrodes with optimum performance, minimizing interfacial resistance, and designing a scalable fabrication approach to facilitate the commercialization of ASSLSBs.

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