INSIGHTS ON QUALITY ASSURANCE

• What's The Difference When It Comes To Managing Quality?

  QA and QC are not identical or interchangeable, but you’re likely to have peers who don’t understand the distinctions between them. Read this blog to help such individuals solve the mystery behind these frequently conflated quality functions.

• Overcoming Biopharma's Top 6 Quality And Compliance Oversights

  This article presents six common quality and compliance missteps that pharma companies either inadvertently enable or unknowingly perpetuate over time, with recommendations for mitigation.

• How To Perform HPLC Method Transfer Between Analytical Testing Equipment

  It is essential for the analytical laboratories to successfully transfer analytical methods. We present a transfer of the HPLC method for related substances analysis of metoclopramide HCl.

• “Continuous Improvement:” Defining Your Purification Process & Product Specifications

  In this Bioprocess Online Live panel discussion, we talk about where the greatest sources of variability are in our downstream processes and how companies should be approaching the question of “how pure is pure enough?"

• 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.

• Eliminating Data Integrity Errors Through Digitization

  10/17/2022

  Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.

• 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.

• Can Life Sciences Untangle Tech Transfer?

  5/19/2023

  Explore the complexities of tech transfer, what is slowing tech transfer down on a commercial level, and the two-pathway approach you can take when adopting digital native tools.

• Demonstrating Control Over The Manufacturing Process: QbD Studies

  1/24/2022

  Explore the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.