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Though autoinjectors have long been used as drug delivery devices to treat diabetes, anaphylactic shock, and autoimmune conditions, they are now expanding into oncology and metabolic disease markets. For patients, they eliminate the need to drive to and from a clinic to receive treatment, reducing travel time and increasing accessibility.
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If your team is aiming to reach toxicology trials with a microbial biologic, the key is finding a manufacturer that can help you rapidly develop processes and provide material for your pipeline candidates. Ideally, these processes will be highly scalable to increase speed once a lead candidate is identified.
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Whether you are partnering from the outset of your program or choosing a dedicated finished goods provider, work with a team that will decipher your goals to ensure your program is a success. A manufacturer should aim to understand and achieve your ideal project outcomes via transparent communication and collaboration.
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All proteins have unique identities based on their structural characteristics and process-related impurity profile. By evaluating the components of a protein’s identity via advanced analytical techniques, you’ll gain the characterization data necessary for regulatory submissions and expand product knowledge to improve process development.
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To accommodate revisions to the European Commission’s Annex 1 regulatory framework, many CDMOs are retrofitting existing fill lines to meet updated environmental monitoring standards. For sponsors assessing different partners, consider the impact of working with a CDMO who designed their fill line with Annex 1 specifications as a guide.
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