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…

Previous PageNext Page