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BioPharm
December 2019
Volume 32, No. 12
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| COVER STORY |

Building a Biopharma Company

Feliza Mirasol

The innovative spirit of biotech startups is a driving force behind the development of new therapeutic products, but building a successful biopharmaceutical company from the ground up has its risks and challenges.
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| QUALITY/REGULATIONS |

Quality Issues Offset Biomedical Advances

Jill Wechsler

Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.
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BioPharm International December Issue
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| DOWNSTREAM PROCESSING |

Prevent, Detect, and Remove: Viral Control for Viral Vectors

Cynthia A. Challener

Ensuring that viral vectors are free of viral contaminants requires a focus on prevention and control.
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| MANUFACTURING |

Antibody Purification Process Development and Manufacturing

Yanhuai (Richard) Ding, Margaret Marino, Hemant Kumar

Downstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.
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| UPSTREAM PROCESSING |

The Evolving Role of Starting Materials in Cell and Gene Therapy

Brad Taylor, Dominic Clarke

Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.
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Did you miss the invite to our webinars?
Did you know Eurofins BioPharma Product Testing produces several webinars each year? Topics this year included bioprocess residuals, sterility, residual solvents, inhalation testing and cell-based bioassays. If you missed any of them, they are still available on-demand. Click to view the full list now and stay up to date on upcoming webinars.
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| FROM THE EDITOR |

Fighting the Good Fight

Rita C. Peters

Nearly four decades after the first diagnosis, the fight to treat HIV/AIDs continues.
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| ASK THE EXPERT |

Investigating Combination Product Failures

Susan J. Schniepp

Investigating deviations or failures of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished
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ON DEMAND WEBCASTS

Multi-Column Continuous Chromatography for Process-Intensified Capture and Polishing of Monoclonal Antibodies
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| EVENTS |

Computer Systems Validation & Data Integrity Compliance Congress

December 9–11, 2019

SMi Group’s 12th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2020

January 15-16, 2020

RNA Therapeutics Conference and Focus Day

February 18–20, 2020

more events

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