Newsletter | January 24, 2023

01.24.23 -- Ensure Microbial Control In The Pharmaceutical Production Environment

Embrace A 360-Degree Approach To Biopharmaceutical Testing Services

A 360-degree approach entails full CMC development and analytical release testing in support of biopharmaceutical products in development and in clinical trials — all from one partner. Outsourced testing also ensures biopharma clients can change manufacturing partners between early development and commercial production while having their analytics needs reliably fulfilled in one place.

Overcoming Limitations To Achieve Uniform Dosing

Formulations of low-dose drugs require a careful balance of several factors to ensure that each dosage has an acceptable blend and content uniformity. Determining the right methods and equipment specifications to pair with the selected material requires expertise across multiple areas of the development process. Choosing the right CDMO can make or break the ability to deliver swift modifications to a formulation.

Components Of An Effective Disinfectant Prequalification Strategy

It is incumbent upon pharmaceutical product manufacturers to ensure microbial control in the production environment through environmental monitoring, microbial identification and trending, and the use of proven and continually updated cleaning/disinfectant protocols. These steps must be taken to ensure compliance with applicable regulatory requirements 1-8 intended to assure the quality of drugs, medical devices, and patient safety.

Selective Crystallization Of A Novel Polymorph

Different polymorphs of the same API can exhibit different physical properties including stability, solubility, and bioavailability in the body. Isolating the stable polymorph reliably in each batch is vital to the success of API manufacturing and formulation. See how rigorous characterization standards and expert knowledge of critical water activity was used to isolate a previously undiscovered and uncharacterized polymorph.

Method Optimization

Cambrex offers a comprehensive method optimization service to take early-stage development methods with poor stability indication, excessive run time lengths, or legacy column chemistries and modify them, where desirable, to shorten run times, improve peak shape, confirm specificity for known related substances, peak resolution, and to enable determination of LOD/LOQ.

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