Search results for " reliability"
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Surrogate sample bags were utilized for adding thermal mass for the large-scale freezing experiments at -80 ˚C, to ensure reliability of freezing temperature profiles. The temperature profiles were r…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
Managing Risk in Raw Material Sourcing
Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.
By Agnes Shanley
Choosing excipients and supplie…
Article
Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Other early efforts were driven by a desire for cost reduction and improving the reliability of raw-material supply. Some of these efforts resulted in the substitution of complex tissue digests or ext…
Article
Process Chromatography Selection for Downstream Processing Applications
Industry experts discuss best practices for selecting a separation technology.
By Caroline Hroncich
Process chromatography has changed significantly since it was first introduced to the biop…
Poster
Residual DNA analysis in influenza vaccine processing
In cell-based influenza vaccine production, the European Pharmacopoeia demands a host cell residual DNA concentration of less than 10 ng per dose. To reliably measure residual DNA in both process sa…
Article
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
Article
Design and Qualification of Single-Use Systems
Also important for SUS users is to qualify the SUT equipment supplier’s reliability and delivery history. Potential supplier performance can be assessed by the experience of integrators and users who …
Article
Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…