News I Sino Bioengineering

ASME has recently published BPE‑2026 Bioprocessing Equipment, an authoritative industry technical standard covering the design and manufacturing of fluid‑processing equipment for the……

The quality of pharmaceutical water is inherently linked to pharmaceutical product quality. Critical parameters of pharmaceutical water, including Purified Water (PW) and Water for ……

In industrial fermentation, pH stands as a critical parameter governing microbial growth, metabolism and target product biosynthesis. Precise real-time pH monitoring and regulation ……

In industrial fermentation, dissolved oxygen (DO) is a critical process parameter, especially for aerobic fermentation. The DO level directly governs microbial growth, metabolism an……

Exogenous microbial contamination in bioreactor cultivation poses severe threats to biomanufacturing processes. Unintended microbial contaminants in bioreactors can significantly re……

Across the full manufacturing landscape of modern biopharmaceuticals, breakthrough therapies ranging from life-saving monoclonal antibodies (mAbs) to cutting-edge gene and viral vec……

As a category of “living medicines”, cell therapy products exhibit markedly higher complexity and variability compared with conventional pharmaceuticals. A risk-based qu……

Water for Injection (WFI) is a critical raw material in parenteral pharmaceutical manufacturing, whose quality directly dictates product safety and regulatory compliance. Convention……

Over the past decades, cell therapy products have achieved remarkable progress in core fields including tumor immunotherapy. As of June 2024, a total of 84 cell therapy products hav……

On November 5, PDA published the revised 2025 edition of Technical Report No. 26 (TR26): Sterilizing Filtrationof Liquids, superseding the 2008 version. This revision incorporates e……

On May 26, ISPE issued a supplementary document to the Commissioning and Qualification (Second Edition), titled QRM Addendum: C&Q Delivery Process. The publication addresses inc……

Recently, the US Food and Drug Administration (FDA) issued the 2026 Inspection Operations Manual, an 839-page comprehensive document detailing FDA’s procedures, policies and guidanc……

HEPA filters serve as terminal air filtration units for processing and purifying supply air in pharmaceutical production facilities. They are mandatory for aseptic manufacturing are……

On 31 July 2026, PIC/S issued PI 006-4 Recommendations on Qualification and Validation. This document covers the organisation, planning, responsibility allocation, objectives and ge……

Quality by Design (QbD) constitutes a systematic, science- and risk-oriented quality management paradigm in pharmaceutical manufacturing, featuring proactive quality assurance in pla……

Within the landscape of modern biopharmaceuticals, if mRNA and viral vectors are the frontline vanguard charging into battle, plasmids serve as the robust rear supply depot furnishi……