Insights On Quality Control

  1. The Impact Of Water Activity On The Chemical and Physical Stability Of Oral Solid Dosage Products 6/18/2020

    This paper presents three case studies to show that direct water activity measurements can determine the impact of moisture on potency and dissolution.

  2. 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?

  3. Effects Of Deep Cold Storage At -80°C On The Container Closure Integrity Of Sterile Product Vials 7/27/2020

    Studies have shown that deep cold storage temperatures can introduce risk to the container closure integrity (CCI) of vial-rubber stopper combinations traditionally used to fill sterile pharmaceutical products. The material properties of the primary packaging components at these low temperatures can sometimes result in gaps appearing at the sealing surfaces.

  4. An Introduction To Residual Seal Force (RSF) Of Product Requiring Deep Cold Storage 7/23/2020

    Studies have shown that robust and consistent vial sealing is critical for maintaining CCI at deep cold storage temperatures. A test to assess how well a vial is sealed is the measurement of the Residual Seal Force (RSF) of the compressed rubber stopper (USP<1207.3). RSF testing provides a way to quantitatively optimize and qualify the vial sealing process.

  5. 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.

  6. How Can Contract Organizations Bridge The Talent Gap In Biopharma? 4/7/2022

    Instrument vendors can play a critical role in decreasing the training timeline for new and even existing staff at a contract organization.

  7. 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.

  8. Leveraging Integration At Each Phase Of A Drug Delivery System Project 4/8/2021

    By forging deeper partnerships with customers, the full depth and breadth of our knowledge, experience and competencies can bring benefits at multiple levels. See how an integrated offering helps at each phase of a drug delivery system project.

  9. Validation Accelerated 9/1/2021

    The challenge: A major pharma company’s need for scale-up and validation of a cGMP intermediate had been delayed for a while when the US FDA suddenly granted it priority status.

  10. Our Biotech Success - Surrozen 4/13/2022

    Surrozen was keen to get started on process development and manufacturing and needed a CDMO with experience developing and producing bispecific antibodies and fusion proteins.