Whitepaper: Early product characterisation mitigates risks in biologics development
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
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Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
Readily deployable, fully integrated mobile testing labs for fast-track delivery of diagnostic and analytical lab capability where and when needed.
The use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
The market is expected to grow at a 6.7 percent CAGR, driven by the increasing prevalence of cancer and cardiovascular diseases, as well as growing interest in biologics.
In this ebook, discover innovative solutions for three core areas of drug development: drug formulation, scale-up and analysis with hot melt extrusion; quality control and validation using microscopic and spectroscopic instruments; and instrumentation for nucleic acid quantification and qualification.
9 February 2021 | By Sartorius
During this on-demand webinar we discuss how to achieve data integrity and give real examples from the US Food and Drug Administration (FDA) warning letters about the most frequent and typical violations.
Strategies for upstream process intensification can be leveraged for cell line development, the seed train, production and cell culture media formulation.
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
G-CON cleanroom PODs. Reliable, flexible prefabricated cleanrooms for the biopharmaceutical industry. On budget and on time.