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Process Robustness and Product Quality for Late-Stage API Crystallization Using a Standardized Project Flow
COMMISSIONING AND QUALIFICATION OF BIOPHARMACEUTICAL CLEANROOMS
This application note provides a guideline of the steps and documentation needed to properly commission and qualify a biopharmaceutical cleanroom.
Regulatory Sourcebook March
An Approach for Extractable AND Leachable Evalulation of High-Risk Infusion Devices
Nephron Pharmaceuticals Compounding Facility Integrates STERIS VHP® Biodecontamination System
Tablet Sticking – How to solve it
How QuVa Pharma Modernized Operations
This case study examines how QuVa Pharma elevated its competitive edge and saw significant efficiency improvements by modernizing its lab and manufacturing operations.
Use of Raman Spectroscopy throughout Formulation Activities
Moving to Prefabricated Cleanrooms in Biopharmaceutical Manufacturing
Premature Release from Wurster Fluid-Bed Enteric Coatings
This paper explores raw material, formulation, process, and equipment design factors that potentially contribute to unexpected early API release from Wurster coated enteric particles.
High sensitivity capillary LC-MS analyses of low amounts of therapeutic antibodies and their subunits
Learn about the use of the MAbPac RP capillary column for utmost sensitivity and excellent selectivity for the mass spectrometric analyses of intact proteins and mAb subunits.
Oligonucleotide mapping using BioPharma Finder software
This work aims to develop and optimize a liquid chromatography (LC) ddMS2 method for the untargeted analysis of oligonucleotides using Orbitrap-based HRAM MS.
Orchestration for Distributed Batch Management
This on-demand webinar shows how to connect unintegrated equipment to achieve real-time visibility across production, centralized recipe management, and batch reporting.
Using Chromatography and Mass Spectrometry Techniques for N-Nitrosamine Analysis
Improving API Synthesis 2021
2021 Pharmaceutical Trend Brief
After a disruptive year in the pharma industry, it’s time to adapt to the next normal. Learn about the four main trends shaping the evolving industry.
Improved Drug Delivery with Precision Particle Fabrication
The Basics of Multi-Layer Tableting
Technical Review of Twin Screw Extrusion Technologies for Life Science Applications v2
Characterizing Pharmaceutical Packaging Systems for Suitability
Pharmaceutical packaging testing is carried out to guarantee suitability of drug packaging for intended uses. Read the Jordi Labs whitepaper to learn more.
Continuous Manufacturing of Injection Molding Tablets
The paper shows the feasibility of Continuous Manufacturing of high reproducible molded tablets through the EMC (extrusion-molding-coating) machine.
Choosing the right mops for cleaning validation and compliance
Download this buyer's guide to learn more about TruCLEAN cleanroom mops and discover the tools and insights you need to form a compliant cleaning program.
Analysis of Two APIs using Multi-Component Analysis
This white paper explains the theory behind the MCA algorithm methodology. Then, used in tandem with in-situ fiber optics, the accuracy of the technique is demonstrated.
Operational Impact of Annex 1 Update
The update for EU annex 1 is more than a simple revision, solidifying the expectation that facility fully understand their processes and systems.
Analysis of polymer fibres
The Virsa Raman analyser is ideal for fiber analysis; whether in a laboratory setting or in industrial research, development or quality assurance.
Detailed Formulation Helps Avoid Production Problems
Formulators must have an empirical methodology to characterize the properties of neat materials/blends to ensure the formulation meets the target product profile.
Expanding Solutions for Challenging APIs Through Coacervation V2
This whitepaper describes the microencapsulation process of coacervation using both aqueous and solvent pathways, and the many benefits for drug developers.
The Age of Big Q
Quantify redispersion potential of Al salt adjuvants in vaccines
This note describes a rapid method for the evaluation of sediment redispersibility in less than 30 minutes using the Turbiscan technology.
Rapid Mycoplasma Testing with Precision
Eurofins BioPharma Product Testing offers a 5-day rapid mycoplasma test comparable in sensitivity and specificity to the 28-day compendial method.
