Newsletter | July 3, 2014

07.03.14 -- Congress To Vote On Prescription Drug Abuse Bill; CHMP Gives Nod To Regeneron's EYLEA Injection

Pharmaceutical Online Newsletter
» Featured Article
The Cost Of Inadequately Scheduling Cleaning Validation
By Charlie Neal, Area Manager, Southeast Region, ProPharma Group
Ever wonder why some — most — projects don't go as planned? Let me take a cut at explaining what I have observed in the last few decades. Firstly, let us assume that you have contracted a well-known consulting firm to assure that you reach the established key milestones. Let us also assume that a Contract Manufacturing Organization (CMO) has agreed to contract process validation services. In particular, the CMO needs support validating the process for a new product. In addition to process validation, this firm will also need to have cleaning validation performed to verify that there are no detrimental residues of this new product left on common processing equipment.
Featured Focus: Critical Environments
Emerging Gloveless Robotic Technologies In Aseptic Manufacturing For Personalized Cytotoxic Drugs
By Sergio Mauri, Manager, BU Integrated Projects, Fedegari Group
The blockbuster model that was driving the pharmaceutical manufacturing industry in the past several decades has almost ended. Massive production, large batches, and high-speed lines have been designed to supply the patients with “multipurpose” small molecule drugs to cover the huge worldwide demand of health for the most common diseases. The next-generation drugs will focus on the single patient and bespoke to cover the individual health demand. For instance, biotech products and large molecules are the most promising therapeutic means for treatment of different kinds of cancer.
WHITE PAPER: Facing The Challenges: Single-Use Approaches To Powder Transfer
By Chris Rombach, ILC Dover
Media and buffer preparation is a key part of the biopharmaceutical manufacturing process, and while it doesn't need to be carried out in sterile conditions, improving the powder transfer process makes this step cleaner, safer, more efficient, protects personnel, and could cut time and costs as well.
WHITE PAPER: Risk Mitigation With Aging Pharmaceutical Facilities
By Maik Jornitz, COO
Aging facilities are a reality and are on the rise. These facilities can work smoothly without problems, but that is often the exception and not the rule.
WHITE PAPER: Adding Up The True Costs Of A False-Positive Sterility Test
PRODUCT: Biopharmaceutical Cleaning Validation
» Packaging
WHITE PAPER: Discussion Of Vial Closures And Stoppering Force In Pilot Freeze Dryers
By Leslie Mather, SP Scientific
SP Scientific, as a supplier of production and R&D freeze dryers over the past decades, has encountered various container closure systems.
DATASHEET: Desiccant Caps/Vials
By Multisorb Technologies
PRODUCT: Aseptic Double Bagging Machine (Syringes Or Vials)
ARTICLE: A Measure Of Success For Quality Control With A Polarimeter
WHITE PAPER: Multivariate Data Analysis For Biopharmaceutical And Biotechnology
DATASHEET: Wi-Fi Data Logger For Humidity, Temperature Control
By Vaisala, Inc.
» Supply Chain
WHITE PAPER: What Is Thermal Packaging Design And How Will I Benefit?
DATASHEET: Biological Asset Logistics Information
By Marken
PRODUCT: Next Flight Guaranteed (NFGsm): Express Air Cargo Services
» Inspection
WHITE PAPER: Why Filler Feedback Is Important For Checkweighers
SERVICE: Lyophilized Product Stability Studies
PRODUCT: Medical Device Leak And Flow Testing
» Manufacturing
BROCHURE: Benchtop Pharmaceutical Roller Compactor- BT 120
BROCHURE: Blow-Fill-Seal Technology For Ophthalmic Applications/Products
VIDEO: Does Your Tablet Deduster Convey This Fast?
Outsourced Pharma West Conference And Exhibition
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.

Process Validation Guide: Regulatory Expectations And Best Practices
Date: Wednesday, July 16, 2014 • Time: 1:00 pm to 2:30 pm EST

The Seven Characteristics Of A World-Class Supply Chain
Date: Tuesday, July 22, 2014 • Time: 1:00 pm to 2:30 pm EST
» Most Recent News
CHMP Gives Nod To Regeneron's EYLEA (Aflibercept) Injection
Endo To Acquire DAVA Pharmaceuticals for $575M
Aspirin Put On The Front Lines For Cancer Prevention
Servier And miRagen Extend Drug Research Partnership
Congress To Vote On Prescription Drug Abuse Bill
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