Insights On Quality Control

1. CDMO Supports Complex Bispecific Antibody Development 4/13/2022

   Read how the expertise, resources and flexibility of one partner have been fundamental in advancing novel and complex bispecific antibody candidates that target the WNT pathway.

2. Principles Of Raman Spectroscopy And Application To Pharma Development 10/26/2020

   Learn how Raman spectroscopy is used to analyze a chemical compound’s structure and an example of how this technique is used to analyze amorphous material created through hot-melt extrusion.

3. Aseptic Vial Filling 6/18/2021

   We offer a unique range of formulation and aseptic filling in vials, prefilled syringes or cartridges to address production needs that span from small early stage clinical products to larger scale commercial products.

4. OPTIMA 7000 Fill Line 6/7/2021

   Ajinomoto Bio-Pharma Services is a leader in aseptic filling, offering a wide range of capabilities for vials with our OPTIMA 7000 fill line. The OPTIMA VFVM 7000 safely processes various types and classes of biopharmaceutical products in 2 mL to 100 mL sizes.

5. Milliflex® Quantum Rapid Microbial Detection System 4/7/2022

   Milliflex® Quantum system is a fluorescence-based microbial detection system, that allows that allows to read out results days earlier than traditional methods.

6. Analyzing Product Formulation Using Raman Microscopy 10/26/2020

   Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.

7. Moisture Headspace Analysis For Efficient Scaleup Of Freeze Drying Capacity And Validation 10/21/2020

   A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations. Activity involved a scale up of freeze-drying capacity from 14 m2 to 28 m2. With the application of non-destructive headspace moisture analysis small scale proof of concept studies were used to minimize project risk and the number of full-scale runs in the freeze-drying validation process.

8. Investing In Capacity – API Commercial Manufacturing 1/20/2022

   A pharmaceutical company sought a CMO partner with commercial manufacturing capabilities and expertise and exemplary quality systems to find a cost-effective process to produce the API for a new drug.

9. Our Biotech Success - Corvus 4/13/2022

   Corvus, a small biotech developing precision medicines, primarily for oncology patients, was seeking to develop a monoclonal antibody called CPI06, now known as Mupadolimab.

10. The Hidden Costs Of GMP Qualification And How Your Supplier Can Help 4/19/2022

    What should you be aware of before starting instrument qualification, and what can an instrument provider do to help you avoid the hidden costs of GMP qualification?