Search results for " industry 4.0"
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
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments, for example, Fab fragments. Various cleaning strategies and …
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
An interview with Aaron Noyes, Head of Downstream Processing at Codiak BioSciences
Some therapeutic targets have long frustrated drug developers hoping to crack the code of mitigating un…
Article
What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
…
Article
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…