Cloud security in a bioanalytical world: considerations for use of third-party cloud services for bioanalysis.

While using the cloud environment for various functions has become commonplace, relatively little attention has been given to considerations for the use of third-party cloud services for regulated bioanalytical workflow and data management. Little guidance has been provided as to how to utilize the cloud to support bioanalytical activities. It can be intimidating when considering how to go about using cloud services for data acquisition, but there are some general ideas to keep in mind when evaluating ways to accommodate regulated bioanalysis online. Determining how to incorporate the use of cloud storage with data that are generated from regulated bioanalytical analysis is an important step in maintaining the security of the data.

Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment.

The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on "Vaccine Stability Considerations to Enable Rapid Development and Deployment", on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry, academia, regulatory agencies, as well as health care leaders. This paper presents a review of the topics covered. Specifically the challenges in accelerating vaccine development and analytical characterization techniques to establish shelf-life were covered. Additionally, vaccine stability modeling using prior knowledge stability models and advanced kinetic analysis played a key in the EUA approaches discussed during the workshop. Finally, the role of stability studies in addressing the challenges of vaccine distribution and deployment during the pandemic were a focus of presentations and panel discussions. Although the workshop did not have any presentation topics directly dedicated to the mRNA vaccines, the techniques discussed are generally applicable. The mRNA vaccine developers were represented in the panel discussions, where experts involved in the EUA approval/deployment stages for this vaccine type could discuss the challenges as applied to their vaccines.

Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.

At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.

Pharmaceutical development of biologics: fundamentals, challenges and recent advances.

The 46th Arden Conference, held in West Point, NY, USA, March 2011, focused on development of protein therapeutics, comprising preformulation, formulation, manufacturing, advanced delivery systems, protein characterization/analysis, and regulatory landscape. The sessions of preformulation and formulation development consisted of nine lectures discussing protein stability implications and characterization during purification, freeze-drying and manufacturing. The session on advanced drug delivery encompassed two new sustained-release microsphere formulations (protein microencapsulation by annealing of premade porous PLGA microspheres and aqueous-aqueous emulsion for preformulating proteins to solvent-resistant particles), two transdermal insulins (patching after thermal ablation of skin and phase-transition hydrogel microneedle patch), and a responsible hydrogel system for intra-ear delivery. The sessions on analytical technologies and regulatory landscape both focused on challenges for biosimilars.