It is critical anyone utilizing single-use technology understands the differences between the various guidances available for extractables analysis and which testing approaches are most suited to the study goals.
Characterization of an originator monoclonal antibody (mAb), or comparability study between originator mAb and biosimilar candidate mAb, are challenging due to the highly complex and variable structure of monoclonal antibodies. The characterization of therapeutic monoclonal antibodies should include a wide range of analytical techniques; as well as binding and cell-based potency assays in order to reflect the main mechanism of action and effector function of the mAb of interest.
The relationship between the basic physicochemical profile and biological activity — and how this relationship affects clinical performance — is a key component of making informed decisions, accelerating development, and reducing risk throughout the product life cycle.
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.
Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.
Single-use bioreactors are widely accepted in the pharmaceutical industry and are increasingly being used to perform mammalian cell cultures in commercial manufacturing applications. They address some of the key challenges the industry faces by decreasing time-to-market, reducing validation efforts, increasing flexibility, reducing investment costs and optimizing cost of goods.
A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.
Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process; therefore, CMC strategies are critical for developing and marketing bispecific drugs.
An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.
This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.
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