Search results for "flexible" in Articles / App Notes
Article
Climate Change in Outsourcing
Global bio/pharma companies continue to look for ways to reduce fixed costs and make their cost structures more flexible. That interest has generated big returns for those clinical CROs that have secu…
Article
Implementing QbD in Sterile Manufacturing
Looking at the operations side, serving multiple customers with different product and process specific requirements, our equipment has to be set-up highly flexible. Such an arrangement offers the bene…
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State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
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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…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Report from the Lanzarote meeting May 13th – 17th, 2013
Yet another well-attended and successful Plasma Product Biotechnology (PPB) meeting has been held. The meeting focu…
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The Development and Application of a Monoclonal Antibody Purification Platform
Such platforms must accommodate the majority of antibodies and yet be flexible enough to cover most contingencies and cell culture or antibody-related processing issues. They must also save time and t…
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QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Additionally, the long-term support through the CPV program is optimal and flexible. As shown in Figure 1, the advantages can also represent a more robust timeline.
The QbD development program e…
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The Future of Biopharma
Many are relying on suppliers' innovations to advance production processes for current biologics, emerging biosimilars products, and for the production of biologics in emerging markets using flexible …
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
Creating effective workflow capabilities that produce multitudes of unique compounds at scales ranging from milligrams to grams levels requires efficient and flexible use of equipment and personnel. T…