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Pharmtech
June 2019
Volume 31, No. 6
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| COVER STORY |

Bringing Drug Delivery Home to Patients

Jennifer Markarian

Combination products aim for user-friendly subcutaneous drug delivery.
/ read more /


|API SYNTHESIS & MANUFACTURING |

Enabling Technologies Advance Poorly Soluble Highly Potent APIs

Cynthia A. Challener

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.
/ read more /


| FORMULATION |

Looking Beyond the Solubility Horizon

Felicity Thomas

Exploration of various formulation techniques is vital to provide effective delivery of poorly soluble drugs.
/ read more /

PharmTech Europe June Issue
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| INHALATION DRUG MANUFACTURING |

Considering Connected Inhalation Drug Delivery

Jennifer Markarian

A connected MDI may encourage compliance and aid proper technique.
/ read more /


| SCALE UP |

Batch or Continuous? Ask the Right Questions During Scale Up

Agnes Shanley

Continuous manufacturing may offer huge opportunities but will not be right for every facility.
/ read more /


| PEER-REVIEWED RESEARCH |

Defining and Managing Raw Manufacturing Data

Orlando López

Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
/ read more /


| GOOD LABORATORY PRACTICES |

Good Laboratory Practices: Getting on the Same Page

Agnes Shanley

Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.
/ read more /


| ANALYTICS |

Leveraging Computational Models of Glycosylation for Biopharma QA

Ioscani Jiménez del Val

Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
/ read more /


| SUPPLY CHAIN |

On the Right Track

Felicity Thomas

Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.
/ read more /


Filling the Early Intermediate Security Gap

Felicity Thomas

With an increased focus on the supply chain security of non-cGMP intermediates, companies need to re-emphasize upstream manufacturing.
/ read more /


| EDITOR'S COMMENT |

As Easy as ABC?

Felicity Thomas

Big Pharma is partnering with Alphabet company, Verily, to modernize clinical trials and accelerate time-to-market for drugs.
/ read more /


| EUROPEAN REGULATORY WATCH |

Regulating Cannabis-Based Medicines in Europe

Sean Milmo

The current fragmented regulatory approach to cannabis medicines across Europe is challenging to harmonize.
/ read more /


| ASK THE EXPERT |

Quality Agreements and Out-of-Specification Investigations

Susan Schniepp

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs.
/ read more /



| EVENTS |

4th PDA Europe Annual Meeting

Amsterdam, The Netherlands
25–26 June 2019

Chemspec Europe 2019

Basel, Switzerland
26–27 June 2019

CRS Annual Meeting & Exposition

Valencia, Spain
21–24 July 2019

more events

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