Search results for " 2018"
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
The Importance of Partnering for Bioanalytical Studies
…that doesn’t contain the interfering molecule?
Bose (Emery Pharma): FDA’s 2018 guidance on bioanalytical method validation (2) is a great place to start. Additionally, while still in draft fo…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioproc…
Article
Successfully Moving Regulated Data to the Cloud
FDA, Data Integrity and Compliance with Drug CGMP–Questions and Answers Guidance for Industry (CDER, December 2018).
Article
Scaling Up Novel Therapies
25, 2018, in a panel discussion on gene therapy. At this point, the FDA has approved one directly-administered and two cell-based gene therapies, Marks said, but the Agency has received over 700 inves…
Article
The Challenge of Disruptive Technologies in Bioprocessing
Jul 01, 2018
Increasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
By Feliza Mirasol [1]By Feliza Mirasol [1]
Increasing demand for biologics is dri…
Article
Understanding Validation and Technical Transfer, Part 2
Madsen, BioPharm International 31 (4) 26-30 (April 2018).
Article
Understanding Validation and Technical Transfer, Part 3
Madsen, BioPharm International 31 (4) (April 2018).
2. R. Madsen, BioPharm International 31 (5) (May 2018).
3. EC, Consultation Document Good Manufacturing Practice for Advanced Therapy…
Article
Establishment of New Modern Plasma Fractionation Facilities in Asia
You are part of the organization committee for the 3rd BioProcessing Asia Conference, which will take place November 12-15, 2018 on Langkawi, Malaysia, and with a session dedicated to plasma fractiona…
Article
CDMOs Driving Emerging Bio/Pharma Success
Analysts who track the industry expect 2018 to be the sixth straight year of substantial new investment in emerging biopharma companies from venture capital, public markets, and partnering. Funding fo…