Search results for "2014"

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
ISO, ISO 16269-6:2014, Statistical Interpretation of Data, Part 6 - Determination of Statistical Tolerance Intervals (Geneva, Switzerland, Jan. 23, 2014). 12. PDA, Technical Report 59: Utilization…

Article Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Chahal, Pharmaceutical Bioprocessing, (2014). 5. R. Kunert and D. Reinhart , Appl Microbiol Biotechnol, 100 3451–3461 (2016). 6. R. Gilbert, Cell & gene therapy insights, 6 (1) 143-148 (2020).…

Article Assessing Manufacturing Process Robustness
ICH, Q14 Analytical Procedure Development and Revision of ICH Q2 (R1) Analytical Validation, Final Concept Paper (2014). 7. FDA, Guidance for Industry, Process Validation: General Principles…

Article Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Figure 3: Single most important biomanufacturing trend (2014 2020) (Selected Findings). (Figure courtesy of the author)  While this might imply that interest in continuous bioprocessing is wanin…

Article Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes. By Susan Haigney natali_mis/Stock.Adobe.com Regulators have been en…

Article Single-Use for Downstream Chromatography: Benefit or Hindrance?
Challener, BioPharm International 27 (6) 34–36 (2014). 2. C. Hroncich, BioPharm International 29 (9) 28–33 (2016). 3. R. Jacquemart et al., Computational and Structural Biotechnology Journal 14,…

Article CoAs Help Secure the Supply Chain
…Veterinarian Use, Part II: Basic Requirements for Active Substances used as Starting Materials (EC, 2014). 5. 21 CFR 211.84(d)(2), Testing and approval or rejection of components, drug product …

Article 3rd BioProcessing Asia Preview: Q&A with John Curling
What is the basic concept for the BioProcessing Asia (BPA) conference series? Until 2014, when we held the first BPA conference, Asia lacked a forum for a science and technology-focused discussi…

Article Process Development: What May Lie Ahead in 2018?
The figures for all new drug approvals are in line with the record numbers of approvals from 2014 and 2015, and the good news may continue into 2018.  As drug companies look for the fastest pathwa…

Article ADC Development Robust Despite Lackluster Performance
In addition to these two ADC programs in development, as well as two other early drug discovery-stage ADC programs, Mersana partnered with EMD Serono, the life-sciences business of Merck KGaA, in 2014

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