Quality Control

INSIGHTS ON QUALITY CONTROL

Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres
Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.
Why Cloud Migration Is The Key To Business Agility
Discover how transitioning to cloud-native architectures drives business agility in biopharma, reducing infrastructure costs, minimizing downtime, and accelerating time to market for novel therapies.
Trend Analysis Of Particle Monitoring Data And Defining Alert And Action Limits
Routine trend analysis of total and viable particle monitoring data helps identify operational shifts early, set statistical limits, and strengthen cleanroom contamination control strategies.
Why Reagent Quality Defines Research Success
Water grade, buffer preparation, and packaging each shape whether sensitive assays hold up. Reagent selection hinges on matching purity to application sensitivity, regulatory standards, and tolerance for contamination risk.

How Sodium Hydroxide CIP Affects Column Performance And Resin Lifetime
9/24/2026

Sodium hydroxide CIP is essential for column hygiene, but cleaning decisions carry real tradeoffs for resin longevity and long-term chromatography performance.
Monitoring, Media Fills, And QC: Demonstrating Sterility Assurance At Your CDMO
2/13/2026

CDMO guide on environmental monitoring, media fills, and QC to prove sterility assurance in aseptic manufacturing—key elements of the Contamination Control Strategy beyond facility design.
Building A Science- And Risk-Based Bio-Decontamination Strategy
10/5/2026

Annex 1 has made bio-decontamination central to sterility assurance, with isolator and barrier cycles now expected to be designed, justified, and reviewed across their lifecycle.
How To Double Up With A CDMO To Reduce Risk
12/12/2025

Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.
What Pharmacies Often Miss In USP <800> Compliance
5/27/2026

Master USP <800> compliance by transitioning from standalone equipment to an integrated system design. Review key protocols for a multi-layered strategy to mitigate cumulative drug risks.

From Vision To Vial – Dalton Pharma Services

An integrated single‑site model unites API development, formulation, fill/finish, and quality systems to provide consistent, compliant support from discovery through commercialization.
Powder Rheology Accessory

The Powder Rheology Accessory expands the DHR’s capabilities to powders, enabling the characterization of behaviors during storage, dispensing, processing, and end-use.
Container Closure Integrity Of Parenteral Products

The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.
Connected Execution And Trusted Data For Sponsor-Ready Results

Bioanalytical organizations are responsible for generating accurate, reproducible data that supports development decisions, regulatory submissions and ultimately faster drug approvals. As sample volumes grow and studies become more complex, maintaining quality, compliance and efficiency can become increasingly difficult.
AP-IS Series: Aseptic Processing Isolator Systems

The Aseptic Filling Isolator is a custom-designed cGMP Class A/ISO 5 isolator system specifically designed for batch scale pharmaceutical production of injectable products for pre-clinical and clinical trial studies.