07.02.14 -- EMD Serono And Mersana Enter ADC Collaboration; FDA's First Draft Guidance Under DSCSA
November 10 and 11, 2014 | Hyatt Regency, San Francisco, CA
• Who should attend? Pharma and biopharm executives who form and manage outsourcing partnerships.
• What's on the agenda? Educational sessions focused on best practices and industry leaders’ experiences and lessons learned to help you avoid costly mistakes.
Register today! Space is limited. Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.
FDA's First Draft Guidance Under DSCSA: What It Tells Us And What It Doesn't By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
On June 10, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren't getting before. Whatever the intent, the draft guidance does provide some learning opportunities, and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang of KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.
Application Note: Removal Of Endotoxin From Monoclonal Antibodies By Sartorius Stedim Biotech
It is desirable to minimize endotoxins in purified protein preparations prior to their use in cell-based assays. Vivapure centrifugal anion exchange membrane devices can remove endotoxin from research-grade monoclonal antibody solutions simply and with high-protein recovery.
White Paper: Securing The Brand Packaging Workflow By Global Vision Inc.
Packaging represents the brand for each product. Shiny surfaces, vibrant colors, and immersive designs all serve a purpose to capture the attention of consumers on crowded retail shelves.
Poster: How To Choose A Solid Carrier For Liquid Formulations By Raghunadha Gupta, Chitra Sundararajan, Thomas Pauly, Fred Monsuur
Get the benefits of solid dosage forms in liquid dose formulations, by converting liquid-based formulations into a solid powder by using a solid carrier to adsorb the liquids. Choosing a solid carrier is a critical factor for a successful conversion, and this study provides details on the most ideal solid carrier.
The smart design of the Eppendorf DASbox makes the 4-fold units ideal for parallel processing of 4, 8, 12, or more bioreactors. Together with the Eppendorf DASware software solutions, the DASbox supports process development following the Quality by Design (QbD) approach by providing comprehensive information management, integration of third-party analyzers, and design of experiments (DoE) tools, as well as remote access via PC, notebook, iPhone, and iPad.
ASI's filling system, when used in conjunction with good technique and a laminar flow hood, yields an aseptic bag fill. The semiautomatic filling system utilizes a fixture and cap assembly developed and manufactured by ASI, and fully controls the filling interface with no user interaction required with the fill port. What is left after completion is a tamper-evident dispensing port. This results in a cleaner, more efficient, and cost-effective method of filling.