Search results for " comparability" in Articles / App Notes
Article
Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
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
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
Article
Biotechnology Innovation and Growth in Israel
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
…
Article
Implementing QbD in Sterile Manufacturing
To gain perspective on the implementation of quality by design (QbD) in sterile manufacturing, BioPharm International spoke with Wolfgang Weikmann, vice-president quality assurance at Vetter Pharma-Fe…
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
The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
The following ar…
Article
Report from India
Pharma industry players brace for challenges as India’s new drug-pricing policy kicks in full gear.
(Dmitry Rukhlenko/Getty Images)
On July 1, India's new…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
The advantage of the CMO in this environment is the large breadth of experience and comparability tools available for the many diverse products using similar process steps.
The first cus…
Article
Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanuf…