Search results for "development"
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Design and Qualification of Single-Use Systems
According to European Union GMP Annex 15, Section 3, “Qualification activities should consider all stages from initial development of the user requirements specification (URS) through to the end of us…
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A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Participants from academia and industry meet and discuss the latest developments in an environment away from the daily routines, rich in scientific quality and engagement, and free from commercial dis…
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A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
It is a good thing with the development of high throughput techniques and Design of Experiments. Otherwise, the multimodal chromatography approach would have been even more challenging. If we know the…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Particle-detection methods
There are various detection technologies that should be used to address protein aggregation needs at various phases of the biopharmaceutical development process; however…
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Finding Opportunities in Brazil
Brazil’s trade is driven by its natural resources, and agricultural and manufacturing production and foreign investment have recently been attracted by scientific and technological development, rising…
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Challenges of Protein Aggregation During Purification
As part of clone selection early on in development, many companies are looking at the characteristics of the molecule produced by clones with good productivity to understand what purification-relevant…
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Pharma Investments Reflect Key Industry Trends
Boehringer Ingelheim also indicated that it would make further investments at the site in 2014 to establish a development lab for biologic drugs.
Bristol-Myers Squibb (BMS): BMS is consolidating m…
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A Q&A With Phil Lester, co-organizer of the HTPD Conference
Process Development Forum spoke with Phil Lester, one of the principal organizers of the conference.
PDF: This is the third HTPD meeting. Can you tell us about the genesis of the conference?
P…
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A Q&A With Parrish Galliher About Adopting Single-Use Systems
Single-use facilities can be built in half the time, so companies can begin construction later in the clinical development process, which reduces capital risk.
There are other factors that are hel…
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Raw Material Variability
Not all of the potential sources of variation are investigated or understood at the process development phase. Thousands of possible variables exist, and many have a trivial impact. The critical ones …