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What CDMO Capacity Refers to and What to Look For

What CDMO Capacity Refers to and What to Look For

by SEQENS North America | Jun 8, 2021 | API Manufacturing, Blog, Capacity, CDMO, SEQENS, Supply Chain, Technology Transfer

Back In 2017 we correctly predicted that API development and manufacturing capacity would tighten.  Since that time CDMO capacity constraints have indeed continued to plague the pharmaceutical industry.  Most recently we have all experienced the consequences...
Passing the Baton in API Development

Passing the Baton in API Development

by SEQENS North America | May 25, 2021 | API Manufacturing, Blog, CDMO, cGMP, Technology Transfer

So, you moved your API out of R&D and into the kilo lab where your CDMO created small trial batches, defined process conditions and performed the process studies needed for cGMP production in the plant. The kilo lab is essential since it ensures you’ve got it...
APIs:  the Superheroes of Drug Development

APIs: the Superheroes of Drug Development

by SEQENS North America | May 17, 2021 | API Manufacturing, Blog, CDMO, NEC

Active Pharmaceutical Ingredients (APIs) are the superheroes of any commercial drug product.  In essence, the drug has no strength without them and are really useless, vacant mediums just waiting for a purpose.  The API is what shows a disease or condition...
Managing Risk in API R&D Requires Strategic Planning, Collaboration and Experience

Managing Risk in API R&D Requires Strategic Planning, Collaboration and Experience

by SEQENS North America | May 7, 2021 | Blog, CDMO, Research and Development, risk management

In drug development, there is an inherent amount of uncertainty, which translates into risk.  Uncertainty is caused by the organic nature of raw materials, making it impossible to predict how an Active Pharmaceutical Ingredient (API) will behave, how much yield...
Manufacturing APIs for Injectables Requires a Safety-First Approach

Manufacturing APIs for Injectables Requires a Safety-First Approach

by SEQENS North America | Feb 9, 2021 | Blog, CDMO, injectables

These days there has been lots of talk about injectables – especially when it comes to COVID-19 vaccines. But aside from vaccines, drug are produced in injectable form to treat a variety of conditions. The benefits of injectable drugs are that they provide rapid...
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