Search results for " expertise"
Article
Tackling Analytical Method Development for ADCs
Feb 01, 2015
By Cynthia Challener, PhD
BioPharm International
Volume 28, Issue 2
The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …
Article
Technologies and Practices Must Evolve to Meet Demand
Reported roadblocks to implementation include insufficient expertise to adapt manufacturing processes to a continuous mode, a lack of proper equipment, and insufficient PAT. Nearly one-third reported …
Article
Trends in Single-use Bioreactors
A good relation with the vendor’s local team, with support from global expertise if needed, would be a good starting point for resolving issues quickly and conveniently.
Sherman (Sartorius): In th…
Article
High-Throughput Process Development in an Historical Environment
The requirement of having a critical mass of robotic users – at different levels of expertise from super-users to general users – and resources was also a common theme.
The workshop was followed…
Article
Continued Process Verification for Biopharma Manufacturing
In practice, the selection of variables for CPV should be determined on a case-by-case basis by those with expertise in the process and with statistical evaluations. For the complete set of tables for…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
…rmining primary and higher-order structures, animal models, simulation tools and complex algorithms, expertise in designing clinical trials that target the appropriate end points and do so with as fe…
Article
Implementing QbD in Sterile Manufacturing
Another significant challenge is the high degree of expertise that must be in place to run a proper QbD approach.
Regarding timing, a much longer timetable has to be included. As for costs, …
Article
Operational Excellence: More Than Just Process Improvement
“To address the increasing complexity of products, we will optimize the use of staff talent and review expertise to improve consistency and regulatory certainty across the wide span of drug quality re…
Article
Navigating Emerging Markets: Middle East and North Africa
In contrast, other countries in the region are struggling with overburdened government-run health systems and are turning to the private sector to provide much-needed investment and expertise (i.e., K…