News I Sino Bioengineering

In biopharmaceutical manufacturing, tangential flow filtration (TFF) is a core unit operation widely applied in buffer exchange, sample concentration, impurity removal and formulati……

I. Exosomes as Clinical Therapeutic Products or Technologies: Multi‑Dimensional Purity Requirements and Regulatory Evidence Packages When products enter clinical research and pharmac……

I. Introduction: Unique Attributes of Radiopharmaceuticals and Core Design Principles As specialized formulations incorporating radionuclides, radiopharmaceuticals occupy an irrepla……

Radiopharmaceuticals refer to radionuclide preparations or radiolabeled compounds intended for clinical diagnosis and therapeutic applications. Distinct from conventional pharmaceut……

In the field of sterile pharmaceutical preparations, product sterility is critical to safeguarding patient medication safety. Sterilizing‑grade filtration has been incorporated as a ……

In aerobic fermentation and cell‑culture processes, oxygen constitutes one of the most critical nutrients. Due to the extremely low solubility of oxygen in water, gas‑liquid mass tra……

In recent years, antibody‑drug conjugates (ADCs) have achieved remarkable advances and accomplishments in clinical research. Owing to their precise targeting mechanisms and compellin……

Beyond conventional protein antibodies and viral vectors, non-viral delivery systems (exemplified by lipid nanoparticle-encapsulated mRNA, mRNA-LNPs) and genetically modified patien……

Oncolytic viruses (OVs) have emerged as a transformative pillar in modern cancer therapeutics. As genetically engineered viral agents capable of targeted recognition, selective infe……

Glycosylation, a pivotal post-translational modification, serves as an essential critical quality attribute (CQA) for therapeutic antibodies, profoundly regulating their biological ……

Filtration technology constitutes an indispensable unit operation across biopharmaceutical manufacturing, serving to remove process-related impurities and contaminants—including part……

Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) systems constitute core utility infrastructure in biopharmaceutical manufacturing, underpinning consistent production line op……

Good Manufacturing Practice (GMP) for pharmaceuticals is underpinned by contamination and cross-contamination control, alongside error prevention. Environmental Monitoring (EM) const……

Prefilled syringe injections represent the third-generation packaging form for injectable pharmaceuticals, following ampoules and vials. Featuring simple and rapid administration, ac……

Blow-Fill-Seal (BFS) denotes an integrated manufacturing process encompassing blow molding, filling and sealing. BFS equipment is an automated system that thermoforms thermoplastic f……

As a core component of quality control, in-process monitoring enables timely detection and rectification of potential quality deviations. Annex 1 to EU GMP — Manufacture of Sterile M……