Newsletter | February 20, 2014

02.20.14 -- As Biologics Development Rises At Pharma Companies, What Does It Mean For Outsourcing?

Pharmaceutical Online Newsletter
Departments:
Critical Environments Manufacturing Logistics
Packaging QA/QC Inspection
» Featured Magazine Article
As Biologics Development Rises At Pharma Companies, What Does It Mean For Outsourcing?
By Kate Hammeke, Director of Marketing Intelligence, Nice Insight
Over the past two years, research results from Nice Insight's annual Pharmaceutical and Biotechnology Outsourcing Survey indicate a rise in the percentage of respondents who work at traditional pharmaceutical companies that are engaged in the development of biologic-based therapeutic drugs.
Featured Focus: Critical Environments
Integration Of Tray Dryers And Nutsche Filter In Containment Isolator System
By Gary Partington, Walker Barrier Systems
Walker Barrier Systems was tasked with providing a system to contain potent and toxic active pharmaceutical compounds to 0.5 μg/m3 exposure level (TWA over operation duration) for an existing lab space. The unit was designed for product filtration, drying in vacuum heat oven, hand sieving and discharging, and final dispensing for further processing, using a Hicoflex system for an existing laboratory.
APPLICATION NOTE: Freeze Drying BioScaffolds: Controlling Pore Size And Structure
By Sophie Koenig, Biopharma Technology Limited
Biopharma Technology Ltd (BTL) recently collaborated with a leading cell therapy company to design and scale up processes for a collagen scaffold implant product.
DATASHEET: QUBE: Modular Biodecontamination System
By Bioquell Inc.
PRODUCT/SERVICE: Containment: Tablet Coater
PRODUCT/SERVICE: Washer/Sterilizer Unit
» Manufacturing
GUEST COLUMN: 5 Common Misconceptions In Freeze Drying
By Dr. Laura Ciccolini, Commercial Director
Freeze drying (lyophilization) is a stabilization method that is widely used in the pharmaceutical industry for drugs, vaccines, antibodies, and other biological material. Freeze drying can be a complex process to handle effectively, but despite improvements in analytical and process science a number of misconceptions persist. Below we look at a selection of those we encounter most often.
WHITE PAPER: Superior Ointments: What's The Strategy?
VIDEO: Future-Proof Rheometry: The New MCR
BROCHURE: Drop-In, Fit-In, And Built-In Sorbent Solutions For Respiratory Drug Delivery Devices
PRODUCT: Used Capsule Fillers
PRODUCT: Pharmaceutical Facility Designs And Pod Systems
PRODUCT: Pharmaceutical Facility Design Services
» Logistics
WHITE PAPER: Before Good Blood Goes Bad: Strategies To Saving Valuable Resources
DATASHEET: Accurate Temperature-Sensitive Shipment Protection
By Envirotainer
SERVICE: Serialization Expertise
PRODUCT/SERVICE: Real-Time Location And Sensor Cargo Tracking
PRODUCT: Polar Pack Gel Packs And Foam Bricks
» Packaging
WHITE PAPER: The Definitive Guide To Decoding Bar Codes
VIDEO: Ropack's Clinical Trial Distribution Reduces Costs And Shortens Time To Market
BROCHURE: Liquid Vials: Sterile Dose Form Capabilities
PRODUCT: Contract Packaging: Packets And Pouch Filling
PRODUCT: Pharmaceutical Respiratory Drug Packaging Equipment
» QA/QC
WHITE PAPER: Streamlining Particle Count Data Management
By Paul Yates, Beckman Coulter Life Sciences
Pharmaceutical cleanrooms have gone through drastic changes in recent years as mergers, acquisitions, facility closures, drug patent cliffs, and other industry dynamics have forced manufacturing facilities to continually adapt to remain both competitive and compliant with U.S. Food and Drug Administration (FDA) regulations.
APPLICATION NOTE: 8 Steps To Mapping Validation Of A Chamber
DATASHEET: Bioburden And Fine Particle Reduction Filters: LifeAssure PNA Series
By 3M Purification
POSTER: Method Development And Validation Of Caffeine And Paraxanthine In Human Plasma
By Rachel Sun, Orlando J. Bravo, and Brian J. Engel
PRODUCT: Flexible Integrity Testing Of Isolator Gloves
» Inspection
CASE STUDY: Sanico Boosts Tablet Inspection To 100 Percent
VIDEO: PakScan Leak Detector: No Product Waste
BROCHURE: High-Resolution Bench Scale: Signum Brochure
PRODUCT: Combination Unit/Tablet Deduster Combined With Metal Detector
PRODUCT: Closure Integrity Testing For Pharmaceutical Containers And Products
SPONSOR
INTERPHEX is the single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms of life-enhancing drugs. See, touch, and procure the latest technologies and innovations, March 18 to 20, 2014, at the Javits Center in New York City. For more information visit www.INTERPHEX.com.
UPCOMING TRAINING

Quality By Design (QbD): Successful Implementation For Pharmaceutical Development And Manufacturing
Date: Tuesday, February 25, 2014 • Time: 1pm – 2:30pm EST

Serialization Program Management And Governance: Defining Roles For Success
Date: Wednesday, March 5, 2014 • Time: 1pm – 2:30pm EST
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