Search results for " development" in Articles / App Notes
Article
Current Innovations and Practices To Address Microbial Contamination in Downstream Bioprocessing
Manufacturers’ efforts to avoid microbial contamination are today being complemented by developments from bioprocessing suppliers.
A multifaceted, collaborative approach is the key to addressing t…
Article
Automating Processes in Upstream Processing
By Susan Haigney
BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies, about automating processes in upstream processing.
BioP…
Article
Advancing Single-Use Technology Through Collaboration
Future Developments
In addition to the extractables testing protocol, work has also been initiated to create a similar best practice document for leachables testing, getting one step closer to eli…
Article
Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
By Susan J. Schniepp
Q: I work in …
Article
Innovation vs. Capacity: How CMOs Compete
…oth new molecular entities and new dosage forms
• Strong pharmaceutics capabilities to support development and manufacture of novel drugs and formulations
• Strong regulatory and quality assu…
Article
Biosimilars: Making the Switch Comes with Challenges
… of a number of top-selling biologics coming off patent shortly, almost 50 new biosimilars are under development (3).
Perceptions on biosimilars
The IMS study, however, has shown that not all…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
…d early decisions can cause unforeseen limitations as the project progresses or, later, when further development of the facility is required. Asking the right questions at the outset and having the d…
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Implications of Cell Culture Conditions on Protein Glycosylation
Optimum cell-culture development is achieved by working with bioreactors to enhance growth and productivity via selection of basal media and culture feeds and the timing for these feeds; optimizing bi…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
In addition, looking at ways to improve on Protein A technology, we are investing in the development of newer-affinity resins (including affinity resins based on Protein L) for the purification of a n…
Article
Relationship Building at Top of Mind for Clients
Add to this the uncertain nature of process development and problems that invariably arise, and it is easy to see how scheduling can be challenging.
That doesn’t make scheduling any less important,…