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BioPharm International
August 06, 2019
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Featured Articles


Science Focus Fuels Successful Process Development for Startups

Getting the science right helps biopharma startups overcome development and commercialization challenges.
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Design Considerations for a Commercial Cell and Gene Therapy Facility

The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
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Gene Therapies Propel Outsourcing Investment

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.
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Upstream Processing


Streamlining Upstream Processing: A Good Place to Start

As cost and time pressures within biopharma are on the rise, innovative expression systems may offer companies a good opportunity to streamline processes early on.
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The Expanding Landscape of Commercial
Single-Use Bioreactors

A look at recent investments by contract manufacturers to increase single-use bioreactor capacity.
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Downstream Processing


Single-Use for Downstream Chromatography: Benefit or Hindrance?

Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
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Catching Up Downstream

Although downstream efficiency still lags behind upstream, engineering-driven innovation is breaking through boundaries.
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Manufacturing


Moving PAT from Concept to Reality

The learning curve for process analytical technology has slowed widespread adoption.
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Comparing Facility Layout Options for Managing Business and Operating Risks

The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.
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Regulations


Playing the Waiting Game with GMP Guideline Revisions

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
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Bioprocessing Facilities and FDA Inspection Problems

FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
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UPCOMING WEBCASTS

From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors
Monday, September 16, 2019 at 9am EDT | 2pm BST | 3pm CEST
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Developing a Robust CQA Monitoring Method via Multi-Attribute Monitoring Principles for Therapeutic Monoclonal Antibody Development, Manufacturing, and Lifecycle Management
Tuesday, September 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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The Versatility of High Throughput Dynamic Light Scattering in Protein Characterization and Formulation Development
Tuesday, August 20, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Native MS for Aggregate and Charge Variant Analysis of Biotherapeutics
Tuesday, August 20, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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ON Demand WEBCASTS

MYCAP® CCX: Cell Expansion of the Future
On Demand
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Improving Confidence and Productivity in Released Glycan Analysis for Biotherapeutic Development
On Demand
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Events

BioManufacturing Conference

September 3–4, 2019

PDA/FDA Joint Regulatory Conference

September 16–18, 2019

PDA Data Integrity Workshop

September 18–19, 2019

more events

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