Search results for " industry"
Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
Article
Gain Efficiency in Process Development
The development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient informatio…
Article
NIST Spectroscopic Measurement Standards
NIST Spectroscopic Measurement Standards
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance mea…
Resource
Continuous Biomanufacturing: Achievements and Challenges for Commercial Implementation
This meeting provides will draw leading international scientists, technologists, engineers and others from across the world. The goal is to provide an electric forum to work together in advancing the …
Article
Efficient Cleaning-In-Place Methods for Protein-Based Antibody Affinity Chromatography Resins
As the use of sodium hydroxide (NaOH) is considered standard in the bioprocessing industry, the impact of treatment of affinity resins with various concentrations of this cleaning agent is demonstrate…
Article
Preclinical Evaluation of Product Related Impurities and Variants
These drugs have become the centerpiece of biotechnology industry and an integral part of modern medicine, evidenced by the annual global expenditure of $1.2 trillion for 2016 (2). These products also…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
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Article
What's in Your SOP?
Whether you work in the medical device, pharmaceutical, or bio-technology industry, you are relying on SOPs to help you perform the day-to-day activities associated with your job. The purpose of an SO…
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QbD Improves Cell-Culture Process Control
QbD Improves Cell-Culture Process Control
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
By Feliza Mirasol
Mar…
Article
What You Need to Know about Continuous Processing
There is a lot of interest around continuous biomanufacturing, and it is expected to have a significant impact on the biomanufacturing industry over the next few years. Continuous processing can hel…