Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.
This presentation demonstrates that in vitro, cell-based assays is an indispensable tool to quantify the biological activities, and to support the potency tests, for bio therapeutics.
By applying remote monitoring, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers process reliability and product quality through connecting machines and data.
Using its Supplier Relationship Excellence program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to optimize operational performance.
To drive dependable critical process control requirements, Biogen explored novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.
Salmon Calcitonin is a peptide with poor oral bioavailability. To assess its potential for oral delivery, Catalent conducted a parallel screening with 2 different technologies targeting duodenal and sublingual biological barriers respectively. Lipid formulations and lyophilized tablet formulations were developed in parallel. Subsequently, based on the animal PK study data, the optimal formulation and dose form was identified which shows the oral bioavailability of Salmon Calcitonin was increased by more than 20 times.
Using workflow based software solutions to guide scientists through various processes in low to high throughput screening campaigns.
As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms.
One tool holds a unique position among R&D informatics systems -- electronic laboratory notebooks (ELNs). ELNs both produce data and consume information and are particularly powerful.
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.
Data-driven risk assessment enables smart decisions on development strategy.
Lonza’s global R&D center for mammalian cell processes is based in Slough, UK alongside a custom manufacturing facility. Lonza undertakes highly specialized development and manufacturing services for the pharmaceutical and biotechnology industries. Read more about Lonza’s complete range of R&D Services and an array of technologies and skills to best match their customers’ requirements for all stages of product development.
Lonza is committed to working closely with our customers to provide cost-effective and time-efficient solutions for their development and manufacturing needs. Read more about our complete service including process development, GMP manufacturing of drug substances, aseptic fill/finish of drug product, product release testing, regulatory support and cGMP storage and distribution.
