Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.
The advantages of contract manufacturing come with certain practical risks. Many of those risks are associated with inadequate communication and knowledge transfer between the drug’s originator and the CMO. Throughout this paper on CMO risk mitigation, we will approach the subject from the perspective of a sterile drug product CMO and establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.
Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.
Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process.
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
With nearly 90 percent of the developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must be prepared to address this obstacle by applying various approaches to improve an API’s pharmacokinetics.
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