Background: Process intensification is a major hurdle in pharmaceutical process scale-up. Solvent removal strategies have limited the effectiveness of the overall stability of pharmaceutical formulations. The main aim of present review article is to focus on the use of the freeze-drying process in pharmaceuticals, biopharmaceuticals and nanoderived therapeutics and their translation into commercial viable products. Unwavering efforts of scientists in the process intensification of lyophilization promote unique features of products for commercialization. Regulatory agencies are promoting the utilization of a quality-by-design approach to improve product characteristics. Among 300 FDA-approved pharmaceutical industries, 50% of products are freeze-dried. The freeze-drying process is costlier and requires more time than other drying methodologies. Unstable pharmaceutical dispersions and solutions can be preferably stabilized by using the freeze-drying method. Main text: This review highlights the utilization of critical quality attributes and process parameters for the freeze-drying process, which helps to improve the integrity and stability of the formulation. The quality-by-design approach possibly cuts the cost of the process and saves money, time, and laborious work. The present review focuses preliminarily on the applications of freeze-drying in the development of biopharmaceuticals, including vaccines, proteins and peptides, and injectable products. In addition, a separate section demonstrating the potential of freeze-drying in nanoderived therapeutics has been illustrated briefly. The present clinical scenario of freeze-dried pharmaceuticals and biopharmaceuticals has also been described in later sections of the review. Conclusions: This review underscores the value of integrating Quality by Design into the development of lyophilization processes for pharmaceutical and biopharmaceutical products. By identifying critical process parameters, delineating a design space, and leveraging advanced monitoring techniques, manufacturers can effectively address the intricacies of lyophilization. This approach empowers them to produce stable, superior quality products with confidence and consistency. Graphical

The surface drying process is an important technology in the pharmaceutical, biomedical, and food industries. The final stage of formulation development (i.e., the drying process) faces several challenges, and overall mastering depends on the end step. The advent of new emerging technologies paved the way for commercialization. Thin film freezing (TFF) is a new emerging freeze-drying technique available for various treatment modalities in drug delivery. TFF has now been used for the commercialization of pharmaceuticals, food, and biopharmaceutical products. The present review highlights the fundamentals of TFF along with modulated techniques used for drying pharmaceuticals and biopharmaceuticals. Furthermore, we have covered various therapeutic applications of TFF technology in the development of nanoformulations, dry powder for inhalations and vaccines. TFF holds promise in delivering therapeutics for lung diseases such as fungal infection, bacterial infection, lung dysfunction, and pneumonia.

Graphene, graphene oxide (GO) and graphene quantum dots (GQDs) are expected to play a vital role in the diagnosis of severe ailments. Computer-based simulation approaches are helpful for understanding theoretical tools prior to experimental investigation. These theoretical tools still have a high computational requirement. Thus, more efficient algorithms are required to perform studies on even larger systems. The present review highlights the recent advancement in structural confinement using computer simulation approaches along with biosensory applications of graphene-based materials. The computer simulation approaches help to identify the interaction between interacting molecules and sensing elements like graphene sheets. The simulation approach reduces the wet-lab experiment time and helps to predict the interaction and interacting environment. The experimental investigation can be tuned at a molecular level easily to predict small changes in structural configuration. Here, the molecular simulation study could be useful as an alternative to actual wet experimental approaches. The sensing ability of graphene-based materials is a result of interactions like hydrogen bonding, base–base interaction, and base-to-pi interaction to name a few. These interactions help in designing and engineering a substrate for sensing of various biomolecules.

The Mycobacterium tuberculosis (MTB) resides in mononuclear phagocytes (macrophages) hence selective targeting at the molecular level using Graphene Oxide (GO) Air Dried Hydrogel (ADH) is investigated in present investigation. The GO has capability to form supramolecular self assembly, due to π – π stacking and hydrogen bonding interactions between surface groups of GO and oppositely charged drug molecule in presence of water. The hydrogel was fabricated using GO and Para-aminosalicylic acid (PAS) in solution phase. The fabricated hydrogel was lyophilized to obtain air dried hydrogel (ADH). The ADH showed potent antimicrobial activity and in-vitro cytotoxicity against S. Aureus and E. Coli, and MCF −7 cells respectively. The Alamar blue assay demonstrated the invasive characteristics of ADH in MTB (H37Rv). From the results obtained so far we lead to conclude that ADH is more invasive compared to the equivalent amount of pure PAS.