Top Stories
An article in Nature Reviews Drug Delivery reports the clinical success rates of biologics, and these numbers differ from those recently highlighted in a similar BIO study.
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As the battle for ownership over the use of CRISPR to edit DNA heats up, some of the CRISPR pioneers refocus their efforts to demonstrate the technology’s applications for editing RNA.
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New pharmacovigilance activities seek to support the creation of guidelines for safe switching from innovator products to biosimilars.
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Industry News
MilliporeSigma surveyed 250 biopharmaceutical executives on how their companies will manage new risks associated with the changing biopharmaceutical landscape.
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The Start-up Hub is designed to give start-up companies the opportunity to network at Pharmapack.
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EXPERT INTERVIEW
Adam Feinberg, associate professor of Biomedical Engineering at Carnegie Mellon University, sat down with Pharmaceutical Technology to discuss challenges in 3D bioprinting.
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Bio/Pharma News
Amyris will use its platform technology to develop a library of natural and natural-like compounds to test against Janssen’s therapeutic target.
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Results of the HERITAGE study were announced at the 2016 American Society of Clinical Oncology meeting.
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Regulatory News
The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.
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PEER-REVIEWED RESEARCH
This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.
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For the past 25 years, the PDA/FDA Joint Regulatory Conference has provided an exclusive forum in which to hear directly from FDA speakers regarding current Agency efforts that could potentially impact the development of global regulatory strategies. Take advantage of a level of direct exchange with the FDA not found at any other conference.
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MANUFACTURING
Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.
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In today’s Quality Management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization, and in many cases, the ability to discern the overall impact of events is a subjective determination.
In this white paper learn about best practices to using Risk Assessment in a Quality Management System.
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Webcasts
On Demand
Join this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
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MES 2016, the life science industry's most in-depth MES-focused event, is packed with breakthrough content and next-generation strategies for achieving the highest ROI on your MES activities. Gain insight on innovative applications and processes to master advanced IT-based solutions. Collaborate on prevailing approaches to ensure manufacturing excellence by successfully deploying, integrating, maintaining and utilizing MES data.
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On Demand
The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for analytical testing programs.Sponsored by SGS Life Science Services
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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
LIVE WEBCAST: Thursday, June 23, 2016 at 11:00 am EDT
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Events
August 10-11, 2016
August 17-18, 2016
September 12-14, 2016
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Bio/Pharma in China
New Initiatives, New Opportunities
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REFERENCE BOOKS |
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A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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eBOOKS
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Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.
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