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...
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...
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...
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...
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...