Search results for " future" in Articles / App Notes
Article
Application of Quality by Design to Viral Safety
However, the benefits include operational flexibility, as future modifications to the purification method that remain within the process design space are not considered changes and do not require addi…
Article
Healthcare Reform in China
Also limiting the possibility of launching domestic patented drugs in the near future and the wave of patented drug expirations serve to strengthen the generic-drug market. The OTC market registers an…
Article
Challenges of Protein Aggregation During Purification
It is very early days, but we are looking forward to, in the foreseeable future, finding good solutions to cell line and expression system construction that will also help the purification process,” s…
Article
Global Expansion Shapes Drug Oversight
To prepare for these and other challenges, USP’s new chief executive officer, Ron Piervincenzi, is consulting with stakeholders, reviewing the organization’s operations, and examining options for futu…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
Biopharmaceutical Industry: Perspectives on Future Growth and The Factors That Will Drive It, published by Battelle and the Pharmaceutical Research and Manufacturers Association or PhRMA. The conclusi…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
…ced to the body by the vaccine may be different than what it encounters in an actual pathogen in the future, according to J. Joseph Kim, president and CEO of Inovio Pharmaceuticals. “Since the immune…
Article
Design of Experiments for Analytical Method Development and Validation
Ranges of the concentration will generate the characterized design space so they should be selected carefully as it will put restrictions on how the method may be used in the future (see Figure 2). No…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
This limitation frequently is one of the primary drivers of establishing the continuous process verification (CPV) program in Stage 3 to monitor the future impact from this raw material variation. For…
Article
Predicting Progress in Protein Aggregation
But progress is being made, and we expect to see some new methods being implemented in the not too distant future,” Zurdo notes.
The behavior of the formulated product once administered to patients…
Article
Early Communication with Regulators is Essential for SMEs
“The lessons learned from this case are multiple and it paved the way for approval of similarly complex medicines in the future,” said Christian Schneider, chair of the EMA’s committee for advanced th…