Search results for "qbd"
Article
Early Communication with Regulators is Essential for SMEs
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
…
Article
2014 Manufacturing Trends and Outlook
However, almost 32% of the respondents have not implemented QbD. Reasons cited for not implementing QbD include a lack of guidance and direction from regulatory agencies (46.2%), no process or quality…
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
Article
A Platform Approach for the Purification of Domain Antibodies (Dabs)
All purification steps were optimized by Design of Experiments (DoE), thereby supporting a Quality by Design (QbD) approach.
Using Capto L, Capto MMC ImpRes, and Capto adhere ImpRes media in …
Article
Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…
Article
Getting your investigational drug regulatory ready
Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational journey. From the submission of an investigational new drug (IND) application, regulators…
Article
Digitalization: The Route to Biopharma 4.0
By transforming data into an intelligence-supporting decision-making tool, it is easy to realize the longstanding regulatory initiatives of process analytical technology (PAT) and quality by design (Q…
Article
Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…
Article
eBook: Purification of Antibody Therapeutics - Approach for Diversified Pipeline
Antibody therapeutics are the largest class of biotherapeutics. Over the years, development beyond traditional monoclonal antibodies (mAbs) has increased. Today, we see multispecific and bispe…
Article
Top Process Development Trends for 2021 and a Look into 2022
The COVID-19 pandemic continues to shape bioprocess development trends, and many lessons have been learned from industry’s response to and preparedness for dealing with a public health crisis. Howev…