Fresenius Kabi (United States)

The chapter reports the advances in engineered biocatalysts with broad substrate scope, improved activity, and stability that have recently emerged as sustainable methodologies for peptide synthesis thanks to their excellent regio- and chemoselectivity and mild operating conditions. A section is also devoted to native chemical ligation technology.

The integration of artificial intelligence (AI) into medical device software has revolutionized healthcare by enhancing diagnostic accuracy, treatment efficiency, and patient outcomes. However, ensuring the reliability, safety, and regulatory compliance of AI-powered medical devices presents significant challenges. The Good Automated Manufacturing Practice (GAMP 5) guidelines provide a structured framework for validating automated systems, including AI-driven medical software. This study explores the impact of GAMP 5 guidelines on the validation process of AI-powered medical devices, addressing key aspects such as risk management, data integrity, and lifecycle management. Through a detailed analysis of regulatory requirements and case studies, this research highlights best practices for aligning AI-driven medical device validation with GAMP 5 principles. The findings underscore the importance of robust validation methodologies to ensure compliance, improve software performance, and enhance patient safety.

The adoption of cloud-hosted Laboratory Information Management Systems (LIMS) in the pharmaceutical and biotech industries offers transformative benefits, including scalability, cost efficiency, and remote collaboration. However, ensuring regulatory compliance in these environments—particularly with standards such as 21 CFR Part 11, GDPR, and GxP—presents significant challenges. This study evaluates the key obstacles faced by organizations leveraging cloud-based LIMS, including data integrity risks, audit trail reliability, electronic signature non-repudiation, and vendor accountability in shared infrastructure models. Through a mixed-methods approach combining literature analysis, case studies, and interviews with industry experts, the research identifies actionable solutions to these challenges. Findings highlight the critical role of robust encryption, immutable audit logs, risk-based validation frameworks, and real-time compliance monitoring tools. The study also underscores the importance of vendor partnerships, staff training, and agile governance models to align cloud agility with regulatory rigor. Results demonstrate that while multi-tenancy risks and jurisdictional ambiguities persist, a hybrid approach combining technical safeguards and organizational protocols can achieve compliance without compromising innovation. This work provides a roadmap for pharmaceutical and biotech firms to navigate the evolving regulatory landscape while harnessing the full potential of cloud-hosted LIMS.

The COVID-19 pandemic has led to a high-stress environment causing a significant impact on frontline workers, including pharmacists and nurses. In addition to the increased workload, scarcity of resources, and emotional challenges, the frontline health care workers are required to wear additional personal protective equipment that can further limit their range of movement and decrease efficiency. The potential for errors can increase in these types of high-stress situations. One way to reduce the risk of errors is to use manufacturer-prepared, ready-to-administer (RTA) prefilled syringes, when appropriate. The use of RTA prefilled syringes is supported by literature evidence, recommendations, and guidelines from various professional organizations and societies.

This work describes lyophilization process validation and consists of two parts. Part I focuses on the process design and is described in the current paper, while part II is devoted to process qualification and continued process verification. The intent of these articles is to provide readers with recent updates on lyophilization validation in the light of community-based combined opinion on the process and reflect the industrial prospective. In this paper, the design space approach for process design is described in details, and examples from practice are provided. The approach shows the relationship between the process inputs; it is based on first principles and gives a thorough scientific understanding of process and product. The lyophilization process modeling and scale-up are also presented showing the impact of facility, equipment, and vial heat transfer coefficient. The case studies demonstrating the effect of batch sizes, fill volume, and dose strength to show the importance of modeling as well as the effect of controlled nucleation on product resistance are discussed.Graphical abstract

Objective The goals of this study were to (1) delineate a technique to prepare stable aqueous vitamin E/Soluplus® dispersions; (2) characterize films cast from the aqueous dispersions; and (3) demonstrate the utility of the aqueous dispersions in fluid bed coating applications. This study demonstrated the feasibility of using vitamin E in the preparation of amphiphilic film withs potential use in delayed-release coating applications. Methods Low viscosity aqueous vitamin E/Soluplus® dispersions were prepared by first spray drying ethanolic vitamin E/Soluplus® solutions followed by high-shear homogenization of the solid dispersions in water. Concentrated (10%) aqueous dispersions containing 0%, 10%, 20%, and 30% of vitamin E in the binary blend with Soluplus® were then cast into films and characterized for contact angle and mechanical strength by texture analysis. Results All films were hydrophilic and homogenous, which confirmed the utility of vitamin E as a plasticizer for the Soluplus® polymer. The 0% and 10% films were brittle whereas the 30% were tacky. The 20% dispersion was subsequently used to coat acetaminophen granules by a fluidized bed process to a dry weight gain of 10–30%. When tested by a dissolution study, a delay in acetaminophen release was observed as a function of weight gain. Conclusion The results from this study demonstrated that it is feasible to produce stable vitamin E/Soluplus® aqueous dispersions to be used as solvent-free functional film coating materials.

In-vitro-derived platelets (PLTs) could potentially overcome problems associated with donated PLTs, including contamination and alloimmunization. Although several groups have produced functional PLTs from stem cells in vitro, the challenge of developing this technology to yield transfusable PLT units has yet to be addressed. The asynchronous nature of in vitro PLT generation makes a single harvest point infeasible for collecting PLTs as soon as they are formed. The current standard of performing manual centrifugations to separate PLTs from nucleated cells at multiple points during culture is labor-intensive, imprecise, and difficult to standardize in accordance with current Good Manufacturing Practices (cGMP). In an effort to develop a more effective method, we adapted a commercially-available, spinning-membrane filtration device to separate in-vitro-derived PLTs from nucleated cells and recover immature megakaryocytes (MKs), the precursor cells to PLTs, for continued culture. Processing a mixture of in-vitro-derived MKs and PLTs on the adapted device yielded a pure PLT population and did not induce PLT pre-activation. MKs recovered from the separation process were unaffected with respect to viability and ploidy, and were able to generate PLTs after reseeding in culture. Being able to efficiently harvest in-vitro-derived PLTs brings this technology one step closer to clinical relevance.