Search results for " report"
Article
Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
Can you tell us why that is?
Eric: Based on our 11th Annual Report, this focus on productivity is changing the way companies outsource, For example, there’s been a real push for more efficiency …
Article
Global Expansion Shapes Drug Oversight
Christopher Hickey, the director of FDA’s China office, reported on increased FDA inspections in China—up to 84 in 2013 from 46 in 2010. Hickey acknowledged that his office has only two full-time fiel…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
EMA has reported that after averaging approximately five submissions per year since 2008, QbD applications went up to eight submissions last year. The rise in QbD applications from a low base could be…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Parenteral Drug Association, Technical Report 60, Process Validation: A Lifecycle Approach (2013).
Article
Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
Article
Biotechnology Innovation and Growth in Israel
In 2010, it was reported that patented drugs accounted for more than 50% of all pharmaceutical sales in the country and approximately 70% of the prescription drug market (9). Moreover, according to Be…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
Today, a typical process accumulates titers of 1-5 g/L, but expression levels as high as 10-13 g/L have been reported (5). The increase in upstream productivity creates a subsequent demand on downstre…
Article
Evolution of the Monoclonal Antibody Purification Platform
The authors reported that the ATPS offers considerable advantages in terms of process economics, especially when processing high titer cell-culture supernatants. For a given amount of mAb product manu…
Article
FDA Seeks Metrics to Define Drug Quality
Most obvious are reports of company recalls, poor inspection outcomes, and adverse events that are visible to FDA and can indicate broader deficiencies in manufacturing process and control strategy.
…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
A recent report (3) from the European Commission looking at Europe’s strong regulatory and commercial foundation for biosimilars found that biosimilars are improving competition in Europe and increasi…