Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.
What is the difference between qualification and validation? This question comes up frequently with both internal and external clients.
4SC AG, a clinical-stage biopharmaceutical company partnered with Thermo Fisher Scientific Pharma Services, whose experienced team helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, leading to a path toward commercial success.
Given the variety of potent drugs in development, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multi-use facility, is an effective strategy.
Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.
Mid-volume capacity bioreactors offer agility in an unpredictable industry and balance the cost of goods as a program prepares to launch.
The secret to performing a thorough solid-state characterization involves integrating all data that may be generated across various instruments at different laboratories and properly interpreting that data.
Describing the pore of a size exclusion chromatography resin with a single number such as average pore diameter is an oversimplification. The formation of pores is dependent on complex combinations of many parameters.
The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.
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.
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.
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.
Utilizing our USP/ICH compliant, state-of-the-art laboratory, Nitto Avecia Pharma Services is capable of detection, profiling and control support of all three classes of residual solvents in drug substances, excipients, and drug products. Rapid analysis, identification, and quantification of impurities is completed in strict compliance of ICH guidelines.
With thousands of methods developed, validated, and/or transferred in support of IND/ANDA/NDA/BLA applications, Nitto Avecia Pharma Services’ scientific team has a proven track record with nearly all drug forms, substances, and products.
