FROM THE EDITOR

What Is the Industry Underestimating About An ADC Supply Chain? – Part 2

In this article, Dan Bell, vice president of regulatory compliance and technical affairs for Marken, discusses regulatory challenges, and both he and Nathan Ihle, Ph.D., VP of CMC Strategy and Management at Seattle Genetics, offer best practices to apply when planning your ADC supply chain.

More From The Editor

PHARMA MANUFACTURING INSIGHTS

  • Best Practices For Handling Potent APIs
    Best Practices For Handling Potent APIs

    This article addresses the issue of how to overcome the industry challenge of handling highly potent APIs using advanced technologies and techniques that can provide a solution.

  • Best Practices To Advance End-Of-Line Packaging Operations
    Best Practices To Advance End-Of-Line Packaging Operations

    Implementing and maintaining a set of best practices is vital to a smooth end-of-line operation. By enhancing operational agility and flexibility, making equipment purchase decisions based on total cost of ownership (TCO), and forming partnerships with original equipment manufacturers (OEMs), pharmaceutical manufacturers can improve this part of their packaging line.

  • How To Mitigate Single-Use Supply Chain Risks
    How To Mitigate Single-Use Supply Chain Risks

    This example goes to show that manufacturers of pharmaceuticals need to not only understand their immediate suppliers (or tier-one suppliers), but also their tier-two suppliers and beyond, as quality problems with components may originate as far down the chain as tier-three and even tier-four suppliers.

  • Crucial Variables Of Pre-Qualified Vs. Customized Temperature Sensitive Shipping Solutions
    Crucial Variables Of Pre-Qualified Vs. Customized Temperature Sensitive Shipping Solutions

    By Melissa Germain, M.Sc., Electro-Optical Systems Laboratory, Georgia Tech Research Institute, and Jean-Pierre Emond, Ph.D., The Illuminate Group

    While the pre-qualified solutions may seem like a good option because the design work has already been completed, if the design criteria do not meet the actual usage, the package may not be effective. By simply understanding a few key variables that go into the design, testing, and real-life practices of temperature sensitive shipping containers, it is possible to determine if a pre-qualified shipper or a customized solution would be best based on risk, cost, and ease of integration.

  • 5 Must-Haves in a Contract Packaging Partner
    5 Must-Haves in a Contract Packaging Partner

    The Pharma and biopharma industries worldwide are focusing on core competencies and outsource their packaging, as confirmed by Contract Pharma's 10th annual outsourcing survey.So what should you look for in a packaging partner?

More Pharma Mfg Insights

PHARMA CONTRIBUTING EDITORS

  • What Is The Reason For Uneven Gender Roles In Pharma Leadership?
    What Is The Reason For Uneven Gender Roles In Pharma Leadership?

    About a month ago, Sanofi put an end to its several-month-long search for a new CEO by selecting Bayer’s Olivier Brandicourt. The day the company announced this move, I published a blog questioning why it’s so often expected that CEO positions in pharma (and really in any industry) will most likely be held by men. This question arose after finding a survey that revealed a majority of respondents believed the position would be taken by a male.

  • Opdivo And Praluent Expected To Lead The Class Of 2015
    Opdivo And Praluent Expected To Lead The Class Of 2015

    Which pharma offerings should you keep an eye on in 2015? Thomson Reuters has released its 2015 Drugs To Watch report, with insights into those medications expected to enter the market this year and make a big splash for their developers.

  • Measure Lives Gilead Returns, And The Returns It Provides
    Measure Lives Gilead Returns, And The Returns It Provides

    Reporting on the cost of Sovaldi (Sofosbuvir) has confused price and value. Gilead isn't bankrupting healthcare; it's bankrolling the system. When we turn negative on a company like Gilead, we turn on our own well-being. 

  • FDA News Roundup: Merck, Actavis, Vertex, And More
    FDA News Roundup: Merck, Actavis, Vertex, And More

    What FDA decisions did you miss this week?
     

  • Can These 3 Anti-Counterfeiting Methods Protect Pharma's Supply Chain?
    Can These 3 Anti-Counterfeiting Methods Protect Pharma's Supply Chain?

    The Drug Quality and Security Act (DQSA) is on the minds of many these days as companies make the necessary investments and launch initiatives to ensure regulatory compliance and supply chain integrity. However, I’ve also been taking note of some of the ways companies and researchers in the industry have been trying to protect pharma products from counterfeiters and keep patients from being fooled by counterfeiters’ increasingly sophisticated tricks.

More From Pharma Contributing Editors

PHARMACEUTICAL ONLINE VIDEOS

  • Industrial Vacuums - Innovative Safety Solutions With An Easy-to-Clean Design
    Industrial Vacuums - Innovative Safety Solutions With An Easy-to-Clean Design

    Nilfisk, one of the world leaders in the production of industrial vacuums, introduces the white line – industrial vacuums for the pharmaceutical and OEM markets.

  • QbD: An Effective Roller Compaction Process
    QbD: An Effective Roller Compaction Process

    A description of the Roller Compaction process and the various process parameters that affect the quality of the roller compacted ribbons. Feed rate, compaction pressure, and roll speed are all discussed.

  • Quality and Manufacturing Complete Control- Keeping Documents on Track
    Quality and Manufacturing Complete Control- Keeping Documents on Track

    Trying to keep track of up-to-date documents and templates can be like chasing down…well you know. But with EMC Documentum Quality and Manufacturing time-consuming reviews and approval efforts can be minimized with centralized control and a unified document repository- all while adhering to GMP compliance and mitigating risks and delays.

  • R&D Submissions Ready- The Mission Control from EMC Documentum
    R&D Submissions Ready- The Mission Control from EMC Documentum

    EMC Documentum Research and Development delivers the control and collaboration needed to sit in the mission control seat. With predefined taxonomies, workflows and templates you can ensure both compliance and up-to-date regulatory submissions.

  • Cold Chain Open House 2014 Webinar
    Cold Chain Open House 2014 Webinar

    Camille Madelon, Strategy and Business Development Director, states, “The industry needs innovation to stay competitive and relevant in the future – to meet new demands, for example due to changing regulations, emerging markets and new drug segments such as personalized medicine.”

More Videos

FEATURED SUPPLIERS

  • Biopharma Technology Limited
    Biopharma Technology Limited

    Lyostat 2 – Fully Integrated Freeze Drying Microscope|Lyotherm 2 - Electrical Impedance (Zsin) and DTA Apparatus|Freeze-drying Contract R&D, Consultancy & Troubleshooting|Comprehensive Training Courses in Freeze Drying Technology

  • Anton Paar USA
    Anton Paar USA

    Anton Paar is the world leader in several areas of scientific instrumentation. Density measurement, rheology, viscometry, and microwave synthesis are the main areas of our business.

  • Sartorius Stedim Biotech
    Sartorius Stedim Biotech

    Membrane & Depth Filter Cartridges & Capsules|Fermention & Bioreactor Systems|Crossflow Micro & Ultrafiltration Systems|Validation & Extractable Testing Services|Water Purification, Air Monitoring & Filter Integrity Test Devices

INDUSTRY PARTNERS

 

 

PHARMACEUTICAL ONLINE SUPPLEMENTS

ABOUT US

The Information Source for the Pharmaceutical Manufacturing Industry

Welcome to Pharmaceutical Online, the premier sourcing site for the pharmaceutical manufacturing industry, find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our product showcase, and offline search service to expedite your discovery of new products and services. Our goal is to help buyers, like you, identify and select suppliers.

Pharmaceutical Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute. Please take a moment to join our community and discover the benefits of your free membership.

Newsletter Signup
By clicking Sign Me Up, you agree to our Terms and that you have read our Privacy Policy.

DEVOTED TO TECHNOLOGY: INTERPHEX 2015

State-of-the-Art Technologies, from Automation to 3D Printing to Barrier Isolation, INTERPHEX 2015 to Feature MORE of the Very Latest in Innovation, Technologies and Knowledge.

Learn More

 UPCOMING TRAINING COURSES

Coping With Change – A Primer for Staff and Managers

March 31, 2015
1pm-2:30pm EDT, Online Training

Got a Date with the FDA? Conducting Successful Meetings

April 7, 2015
1pm-2:30pm EDT, Online Training

An Introduction to Good Laboratory Practices (GLP)

April 8, 2015
1pm-2:30pm EDT, Online Training

Preparing Personnel to Interact with Regulatory Inspectors

April 15, 2015
1pm-2:30pm EDT, Online Training
More Upcoming Courses

 PHARMACEUTICAL EVENTS

Coping With Change – A Primer for Staff and Managers

March 31, 2015
1pm-2:30pm EDT, Online Training

Got a Date with the FDA? Conducting Successful Meetings

April 7, 2015
1pm-2:30pm EDT, Online Training

An Introduction to Good Laboratory Practices (GLP)

April 8, 2015
1pm-2:30pm EDT, Online Training

CPhI South East Asia, P-MEC, InnoPack

April 8 - 10, 2015
Jakarta
More Events....