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.
Identifying the optimal formulation and dose form which shows an increase more than 20 times in the oral bioavailability of Salmon Calcitonin.
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.
Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Most of the brightest chemists chose to spend their time “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to critical aspects of scale-up like safety, waste management, or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines) far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst-performing sectors in terms of waste produced per unit of product made. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus a new field of chemistry called process research was born.
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.
Backed by Lonza’s more than 30 years’ experience and expertise in biological processing and our track record in the chemical and biotechnological industry, we offer our customers a full “one-stop-shop” service package at all stages of development and production.
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.
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.
