In mammalian-cell-based bioprocesses the most common critical process parameters (CPPs) include physical parameters (temperature, pressure, dissolved oxygen [DO] levels) as well as chemical properties (pH, concentrations of both substrates and byproducts) and biochemical properties (cell number and viability, cell physiology).
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Many organic compounds can crystallize in several different forms called polymorphs. Biologically active polymorphs have different solubility and stability and, hence, different bioavailability. The effectiveness of a drug compound depends critically on its particular polymorph.
The biopharmaceutical industry, especially manufacturing facilities, needs to implement bacterial identification to avoid the occurrence of a problematic microorganism in the final product that could be harmful for the end user and detrimental to a company’s finances and reputation.
Case study involving the use of the ExpiCHO™ mammalian transient expression system...
Raman monitoring of blended granule uniformity prior to tablet press...
This article discusses options for selection of reagents and the extent to which they influence synthesised mRNA functionality...
The aim of Quality by Design (QbD) is to build quality into a product and process from the outset. The pharmaceutical and related industries utilise powder blending operations to make solid dose drugs, yet the phenomena of powder mixing is the least understood of all sciences.
Hollow Fibre Diafiltration is rapid alternative to traditional methods of nanoparticle purification like ultracentrifugation.
Application Note: The sterility of the ControLyo™ process: reducing freeze dried product batch time without compromise to system integrity
Controlled nucleation is the most significant new development in freeze drying in quite some time.
The Milliflex® Quantum system (Merck Millipore) is a rapid method for the quantitative detection of contaminants in filterable samples...
Raman spectroscopy offers a rapid, convenient method for positive identification of pharmaceutical products and their raw materials – on the manufacturing floor, in inventory, and at the shipping dock.
Scandinavian Micro Biodevices (SMB), in Denmark, develops, produces and markets ‘point-of-care’ diagnostic systems for the veterinary market. In order to maintain a very low level of humidity in the clean room, a desiccant dehumidifier is required.
Heated crystalline pharmaceutical compounds undergo morphological changes that can be observed under a microscope. With hot-stage microscopy changes in melting points and ranges or crystallisation can be visualised for research and QC purposes in order to influence drug stability or effectiveness...
Application note: In-line PAT solutions for understanding and controlling fluidised bed granulation (FBG) processes
Determining CPP’s in DoE using Eyecon particle characteriser and Multieye Multipoint NIR.
Application Note: Multiparameter profiling of a Structure Activity Relationship (SAR) library for immunological activity in human PBMCs
We describe a no-wash, high throughput screen that provides a multiparametric activity profile for a structure activity relationship (SAR) library derived from immunomodulatory compounds...