Navigation Links
Reportlinker Adds Upstream Processing in Biopharmaceuticals - Increasing Use of Low-Cost Disposable Bioreactors to Drive the Upstream Bioprocessing Market

ing in Biopharmaceuticals – Guidelines, Regulatory Landscape 88

8.1 Quality by Design (QbD) 88

8.2 Process Analytical Technology (PAT) 90

8.2.1 Importance of PAT 91

8.2.2 Factors Limiting Implementation of PAT 91

8.2.3 A summary of PAT benefits is as follows: 91

8.3 ICH Guidelines 92

8.3.1 Q5A (R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 92

8.3.2 Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products 92

8.3.3 Q5C: Quality of Biotechnological Products Stability Testing of Biological Products 93

8.3.4 Q5D: Derivation and Characterizations of Cell Substrates Used for Production of Biotechnological/Biological Products 93

8.3.5 Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 94

8.4 The US Regulatory Landscape 94

8.4.1 PHS Act 94

8.5 Europe Regulatory Landscape 95

8.5.1 EMEA Guidelines 95

8.5.2 Key Changes in EMEA Guidelines 98

8.5.3 Types of Guidelines within the Biologics Legislative 98

8.6 Japan 98

8.6.1 Health Policy Bureau 98

8.6.2 Office 1 99

8.6.3 Office 2 99

8.6.4 Review and Guidelines 99

9 Upstream Processing in Biopharmaceuticals – Strategic Consolidations 100

9.1 Reasons for Strategic Consolidations in Biologics Manufacturing 100

9.1.1 Uninterrupted Supply to Meet the Demand 100

9.1.2 Overall Cost Reduction 100

9.1.3 Global Expansion to Stay Ahead in Competition 100

9.1.4 High Regulation Requirement 100

9.1.5 Acquiring Technical Expertise 100

9.1.6 Time Pressure and Synergy Innovation 101

9.2 Potential Problems in Strategic Consolidations 101

9.2.1 Incorrect Valuation 101

9.2.2 Capital Problem 101

9.2.3 Compliance Difficulty 101

9.3 Importa

SOURCE Reportlinker
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related biology technology :

1. Reportlinker Adds Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment
2. Reportlinker Adds Quantum Dots: Technologies and Global Markets
3. Reportlinker Adds Global Angiongenesis Inhibitors and Stimulators Industry
4. Reportlinker Adds Global Nanobiotechnology Industry
5. Reportlinker Adds Global Biochips Industry
6. Reportlinker Adds Diabetic Retinopathy Therapeutics - Pipeline Assessment and Market Forecasts to 2017
7. Reportlinker Adds World Market for Molecular Diagnostics: Potential and Reality, Whats Hot and Whats Not , The
8. Reportlinker Adds Three Alternative Scenarios of the Future In Vitro Diagnostics Market through 2018
9. Reportlinker Adds The 2011 Clinical Chemistry and Immunodiagnostics Markets: US, Europe, Japan; Product Development Opportunities and Business Expansion Strategies for Instrument and Reagent Suppliers
10. Reportlinker Adds The 2011 Top Ten Worlds Leading Life Science Intermediates Companies
11. Reportlinker Adds Biomarkers - Technologies, Markets and Companies
Post Your Comments:
(Date:9/30/2014)... The overall research objective was to ... and use. Most researchers outsource NGS technologies; however, ... within the next 12 months. Data accuracy and ... sequencing instruments. Disease-related research is the dominant use ... to surge, with half of the respondents planning ...
(Date:9/30/2014)... 2014 Rainbow Scientific, Inc. (RSI), ... recently opened an online store to add customer ... lines developed and manufactured by Biological Industries, Inc. ... Biological Industries’ Nutristem® serum-free, xeno-free reagents for human ... cell (hESC) culture. , The online store ...
(Date:9/30/2014)... 30, 2014 Back in the 1970’s, many ... feet. per employee, which included space for circulation and file ... Jeff Howell, partner at Nidea Corporate Real Estate / ... “By the year 2000, however, 250 square feet per ... number come down to 175 to 225 square feet, and ...
(Date:9/29/2014)... the start of the military conflicts in Iraq and ... United States with traumatic brain injury caused by exposure ... improvised explosive devices, or IEDs. Symptoms of traumatic brain ... headaches and nausea, to more severe impairments in memory ... of Defense has recognized the critical importance and complexity ...
Breaking Biology Technology:Global Next-generation Sequencing Trends 2Rainbow Scientific, Inc. opens online store for state-of-the-art stem cell culture and cytogenetic reagents 2ITRA Global Reports on How Companies Are Squeezing More Employees into Less Office Space 2ITRA Global Reports on How Companies Are Squeezing More Employees into Less Office Space 3Modeling shockwaves through the brain 2Modeling shockwaves through the brain 3Modeling shockwaves through the brain 4
... race the fastest cars they can build and win the ... and technicians from Ohio State University (OSU) and Wisconsin-based ... million dollar grand prize awarded to the winner of the ... Research Projects Agency (DARPA) has a Congressional mandate to reward ...
... announced today the hiring and appointment of Tom Schwei ... bioinformatics company. Schwei has 25 years of local business ... PanVera Corporation and Invitrogen Corporation. , ,Tom brings ... said Fred Blattner, DNASTARs chief of operations and president. ...
... kettle of molten steel as the representative symbol of ... to the cubicle farm. Instead of coke and iron ... transform data and information into knowledge and ideas: An ... its output is knowledge. Every physical product has a ...
Cached Biology Technology:Oshkosh Truck Teams with OSU to Compete in DARPA Million Dollar Tech Derby 2Oshkosh Truck Teams with OSU to Compete in DARPA Million Dollar Tech Derby 3Transforming Information to Knowledge 2
(Date:9/29/2014)... "human activities in this area of the world have contributed ... grown for use as a cooking oil and biofuel, while ... the most widely produced edible oil in the world, and ... soybean oil. , The environmental effects of such growth have ... crop, and the preferred method is fire. The clearing often ...
(Date:9/29/2014)... MADISON, Wis. Mountain pine beetles get a bad ... for killing pine trees over tens of millions of ... last decade. , But contrary to popular belief, ... severe wildfires like those that have recently swept through ... role in the ecological severity of fires than these ...
(Date:9/29/2014)... (Boston) A review article published online in ... that happen in the brain as a result of ... the sleep cycle. , Clinical assessments and research ... from severely disrupted sleep. This can occur when people ... or when they are abstaining. , "Sleep-wake disturbances ...
Breaking Biology News(10 mins):Tree killers, yes, fire starters, no: Mountain pine beetles get a bad rap, study says 2Tree killers, yes, fire starters, no: Mountain pine beetles get a bad rap, study says 3Tree killers, yes, fire starters, no: Mountain pine beetles get a bad rap, study says 4
... about the quality of ingested food. It comprises five ... stimuli. The possibility for an additional taste modality ... animals exhibit a spontaneous attraction for fats, but the ... debate. , In a paper appearing in the ...
... from researchers at Harvard Medical School and Massachusetts Institute ... Cancer Conference (ECCO) have shown for the first time ... , Nucleic acid ligands (referred to as aptamers) ... to target antigens with high specificity and affinity; analogous ...
... may owe its existence to tiny microorganisms living in ... the vital services these microbes perform for the planet ... the American Academy of Microbiology, entitled Marine Microbial Diversity: ... likely began in the oceans, marine microorganisms are the ...
Cached Biology News:Researchers use 'trickery' to create immune response against melanoma 2Researchers use 'trickery' to create immune response against melanoma 3Researchers use 'trickery' to create immune response against melanoma 4Understanding the oceans microbes is key to the Earth's future 2
... The biolistic PDS-1000 He system ... gas to accelerate micron-size nucleic acid-coated ... necessary to transfect cells, tissues, or ... the cell surface. The system includes ...
Sf21 Insect Cells (Frozen) in Max-XP Medium...
... is used for conventional PCR and thermal ... personal thermal cycler, which features a 96-well ... tubes or plates, programmable time, temperature, and ... modes of temperature control. The system also ...
... with colony-picking capabilities, 110-120 V, uses floating ... oligonucleotides, carbohydrates, lipids, and other biomolecules onto ... This system can also be used for ... in diameter and for inoculating 96- or ...
Biology Products: