The manufacturing process of fermented new drugs is complicated, and the quality control is difficult. Referring to the relevant technical guidances of new drug chemistry, manufacturing, and control research, centering on the quality control characteristics of fermented new drugs, this article discusses the general considerations on the manufacturing process, elucidation of structure, specification research, to provide a reference for the research of fermented new drugs.

Single-cell sequencing advances the research of molecular biology and cell biology to the single cell level by integrating the latest technologies such as single-cell dissociation, microfluidic, microfluidics system, high-throughput sequencing, and bioinformatics. It is a milestone technology in the history of biotechnology. Single-cell sequencing technology provides a new dimension for the study of basic biomedical problems such as ontogeny, cell differentiation, cell heterogeneity in tissues, and the etiology and development of diseases, and has been widely used. In this review, we briefly introduced the development of single cell sequencing technology and assocatied bioinformatics methods, and reviewed its application in the process of drug development, such as study on mechanism of disease, target discovery, drug discovery and optimization, mechanism of action and clinical trial design.

As a continuous cell culture technology, perfusion fermentation is more beneficial to cost control than traditional batch fermentation and can be flexibly arranged according to the supply change. In this paper, the characteristics and advantages of perfusion fermentation are clarified by comparing the batch fermentation with perfusion fermentation. In combination with the guidelines currently being drafted by the International Council on Harmonization, the considerations for pharmaceutical evaluation of cell passage stability study, batch and scale definition, process control, viral safety, and process verification of perfusion fermentation are summarized in this paper.

Complex injections are usually a kind of modified new drugs with new dosage forms, formulations and manufacture processes. It is an effective method to reduce inherent deficiencies of active ingredients with advanced techniques. Complex injections can reduce side effects of drug substances, improve drug efficacy, promote patients' compliance and so on. In the increasingly competitive generic drug market, they have obvious clinical advantages and market competitiveness. However, complex injections usually own complicated formulations and processes. Based on guidances and policies at home and abroad, in this paper, we briefly discussed the CMC requirements for complex generic injections according to the characteristics of different complex injections.

Continuous manufacturing is one of the development directions of the production process of recombinant biotechnology products in the future. The promulgation of important technical documents such as ICH Q13 also provides guidance for its application practice. However, in the field of viral safety control, there are great differences in control concepts and measures between continuous manufacturing and previous batch manufacturing mode. Starting with the process characteristics of continuous manufacturing, this paper makes a preliminary discussion on three aspects, which are the control of raw materials, in-process test, and virus removal/inactivation process validation. At the same time, as the cases of continuous manufacturing of recombinant biotechnology products are still limited, more comprehensive and meticulous control strategies and measures still need further accumulated and improved based on R&D and production experience. It is suggested that the applicants of this kind of products should fully communicate with the regulatory authorities before the application, so as to ensure the safety of the subjects or patients through scientific and rigorous trial design.

Clinical study for medicine products is a time-consuming and high-cost project. As a great tool of optimizing trial design, simulation technology plays an important role in different phases and different indications of clinical trials. At present, different regulatory agencies have established corresponding technical requirements for simulation technology. This paper summarized the development of the guidelines of NMPA, FDA, EMA, and ICH to elaborate the regulatory status of simulation technology. Without additional clinical trial data, one pharmaceutical company successfully expanded the indications of adalimumab in adults for hidradenitis suppurativa to adolescent by virtue of only model simulation results. This article analyzed this case in detail to illustrate the importance of simulation technology. Finally, this paper discussed the advantages and disadvantages of simulation technology, as well as the considerations in practical application.

The concept of analytical quality by design (AQbD) guides pharmaceutical industries in the development and maintenance of systematic analytical procedures using scientific knowledge and quality risk management approach. The quality control of biological products is the critical content of the pharmaceutical research and evaluation, and is important to ensure the safety, effectiveness and stability of products. The analytical procedures used for quality control contribute to the quality control system. Lifecycle management of analytical procedures includes analytical procedure development, validation, transfer, change and continual improvement. This article introduced the concept and application of lifecycle management of analytical procedures and regulatory considerations according to the quality control characteristics of biologics and the experience of drug evaluation.

Blood products are manufactured by separation of plasma from healthy donors, which have a wide range of indications and play a critical role in the prevention and treatment of certain major diseases. However, because of the uniqueness of their source, the viral safety of blood products is always highly concerned by various national regulatory authorities. This manuscript discussed viral safety-related issues of blood products in combination with technical review practice, from aspects like source plasma, virus removal/inactivation processes, regulation requirements and considerations in technical review, etc., in order to provide references for future research and development.

Stem cells have the potential of self-renewing and multilineage differentiation. Different types of stem cells have different advantages and limitations. It has become a hot topic of basic research and clinical application. Currently human-derived stem cell products to be developed as drugs come mainly from adult stem cells, embryonic stem cells, and induced pluripotent stem cells. Human-derived stem cell products are complex and diverse, showing unique therapeutic advantages in the treatment of a variety of diseases. This paper summarizes the characteristics and the latest research progress of human-derived stem cell products. According to the drug development and evaluation rules, this article brings up some quality assessment concerns and discussions in the major fields, such as raw materials, manufacturing process, quality research and control, stability, packaging container system, for the industry and regulators to discuss and communicate, expecting to promote the clinical transformation and application of this class of products.

Taken literature in the field of pharmacovigilance risk management from 2002 to 2021 in the Web of Science Core Collection database as sample data, used Excel and Cite Space software to conduct bibliometric analysis on research trends, literature sources, research subjects and research hot spots of relevant literature, and to construct the knowledge map in the field of international pharmacovigilance risk management. Study shows that the field of international pharmacovigilance risk management presents obvious phase increasing characteristics overall. The research institutions are divided into four cooperative groups: the United States, France, the Netherlands, and Italy. There are three models of groups with close cooperative relationships: university-university, university-medical institution, and government agency-medical institution, and the cooperative relationship among institutions has been gradually strengthened. Research hot spots are focused on adverse drug reactions, signal detection, pharmacoepidemiology, etc. Drawing on the international research results, the development of pharmacovigilance risk management in China can be enlightened from their research subjects and research hot spots.