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The Lead

Fitch: Biologics Driving Revenue Gains for U.S. Pharmaceutical Companies

July 29, 2014 3:39 pm | News | Comments

Fitch Ratings expects that revenues from biologic therapies as a percentage of total pharmaceutical sales will continue to increase over the intermediate term as companies increase their prominence in their drug portfolios, according to a report published today.

Report: Global Biotech Industry Needs New Paradigm for Drug R&D

June 24, 2014 8:11 am | News | Comments

The global biotechnology industry rebounded strongly in 2013, with public companies achieving...

Nature's Chem Lab: How Microorganisms Manufacture Drugs

June 19, 2014 1:00 am | by University of Michigan | News | Comments

Researchers at the University of Michigan have obtained the first three-dimensional snapshots of...

Report: Lucrative Biosimilars Space to Erode Biologics Market from 2019

June 10, 2014 9:02 am | News | Comments

The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics...

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The 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

June 5, 2014 1:37 pm | News | Comments

A global analysis of 238 biomanufacturers and 178 suppliers in 31 countries — the 514 page study is the industry's definitive, quantitative analysis and includes 11 years of biopharma trends and opportunities, including in-depth analysis of specific issues affecting the industry.

Pharmaceutical Processing's April 2014 Edition

April 11, 2014 12:00 am | Digital Editions | Comments

The April issue of Pharmaceutical Processing profiles Reed-Lane, a contract packager of solid-dosage products based in Wayne, NJ. Additional articles on contract services and outsourcing topics include a look at the global biosimilars market and an update on solid dosage manufacturing services. In addition, the benefits of using ready-to-fill vials is explored. Other topics covered in this issue include packaging inspection, anti-counterfeiting technologies, lab design and expediting drug development.

Patients Granted Access To Interchangeable Biologic Medicines

March 26, 2014 10:02 am | by Associated Press | News | Comments

The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for signing legislation today designed to create a pathway for the substitution of interchangeable biologic medicines. 

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Alvotech and Finesse Announce Biomanufacturing Collaboration

March 13, 2014 11:55 am | News | Comments

Alvotech, a new company in the field of biopharmaceuticals and Finesse Solutions, Inc. today announced that they have entered into a partnership that will provide Alvotech with world-class, scalable, flexible and cost-efficient manufacturing and laboratory technology through the Finesse turnkey SmartFactory® GMP manufacturing platform suite.

IPS Tech Tips Episode 2: Changes in Biopharmaceutical Design

March 11, 2014 10:53 am | Videos | Comments

Peter Hanson, IPS' Director of Process Architecture, Asia and EMEA talks about changes in biopharmaceutical design for facilities in these emerging markets including shifts in investments and the types of investments.        

INTERPHEX - PDA Education Program Spotlight: Parenteral Packaging

March 7, 2014 11:14 am | News | Comments

As  drug development continues to increase complexity, so do the primary packaging solutions that are being employed. Primary containers are no longer to considered as inert components whose sole function is to contain a drug product, but rather as an integral part of a drug delivery system.

Metadata Management is on the Rise in Biopharma

March 7, 2014 10:39 am | News | Comments

Half of biopharma companies now have a Metadata Management project under way, according to a survey conducted by SOA Software. This finding shows that metadata management is emerging as a compelling solution for many biopharma businesses.

Education Spotlight: IPS Experts Presenting at INTERPHEX 2014

March 5, 2014 2:38 pm | News | Comments

IPS-Integrated Project Services a leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities has announced four presentations to be given by the company’s subject matter experts during INTERPHEX 2014 in New York City.

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Caliber Recognized for Excellence In Technology

March 3, 2014 12:28 pm | by Jeff Reinke; @JeffReinkeABM | Articles | Comments

The Caliber Biotherapeutics manufacturing facility in Bryan, Texas offers an interesting look at the development and integration of Plant Made Pharmaceuticals. This commitment to new and innovative drug development strategies has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.

Pharmaceutical Processing Announces 2014 Facility Excellence Award Winners

March 3, 2014 12:15 pm | by Jeff Reinke; @JeffReinkeABM | Articles | Comments

New development technologies, expanded contract manufacturing and service capabilities, as well as innovative equipment investment strategies highlight leading practices from the best in pharmaceutical processing comprise the 2014 Pharmaceutical Processing Facility Excellence Award winners.

Olympus Biotech Selling New Hampshire Biopharmaceutical Manufacturing Facility

March 3, 2014 11:40 am | News | Comments

Olympus Biotech today announced the initiation of an aggressive transaction process to find a buyer of its West Lebanon, NH manufacturing facility over the next 90 days. In recent months, the Company has received interest from buyers and contract manufacturing organization (CMO) partners, but no deal has been consummated yet.

Pharmaceutical Processing's January/February 2014 Digital Edition

February 28, 2014 10:42 am | Digital Editions | Comments

The Jan/Feb 2014 issue of Pharmaceutical Processing is our INTERPHEX 2014 Preview issue and features numerous exhibitor highlights and a guide to the educational conference program. In addition, we profile Xcelience, a clinical trial material contract manufacturer based in Tampa, FL.

Plug-N-Play in Biopharma Processing

February 14, 2014 1:52 pm | by A. Mark Trotter, Marketing Manager, 3M Purifications Inc. | Articles | Comments

The use of disposables in biopharmaceutical production facilities started in the late 1990’s and has evolved to include innovative Single-Use Systems (SUS) products from upstream bioreactors/clarification filtration to downstream separation and purification applications, TFF, membrane chromatography, and virus removal.

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Biopharmaceutical Mixing

January 28, 2014 12:44 pm | Product Releases | Comments

Allegro single-use mixers are part of the company's expanding range of Allegro products and services providing integrated process solutions throughout the drug production process. The Allegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering principles and criteria for robust mixer design to deliver the ultimate in mixing performance.

Single-Use Biopharmaceutical Products

January 28, 2014 11:56 am | Product Releases | Comments

BioPure single-use tubing connector systems simplify production operations, lower costs of GMP Pharma manufacturing and reduce process validation time. Peristaltic pumps contain fluid to be pumped ensuring isolation from any source contamination.

Single-Use Diaphragm Pumps

January 28, 2014 11:41 am | Product Releases | Comments

This single-use line of four-piston diaphragm pumps is designed for utilization in biologic-handling applications within pharmaceutical and biotech operations. The Quattroflow product line consists of five pump sizes—QF150, QF1200, QF4400, QF5050 and QF20K—with capacities between 1 and 20,000 L/hr (5,283 gph).

Single-Use Mixing System

January 28, 2014 10:54 am | Product Releases | Comments

The Saltus® M200 is a 200 L single-use mixing system for biopharmaceutical manufacturing processes, powder-liquid and liquid-liquid mixing.

Integrated Biomanufacturing Solutions

January 27, 2014 2:14 pm | Product Releases | Comments

GE Healthcare has a range of integrated solutions that comprise products, platform technologies, and services designed to enable efficient and robust bioprocess manufacturing. 

11th Annual Global Biopharmaceutical Manufacturing Study

January 27, 2014 8:50 am | News | Comments

Participate in the bio-industry's most in-depth, global study: 11th Annual Biopharmaceutical Manufacturing Report and Survey.                   

Emergent BioSolutions to Acquire Cangene Corporation

December 12, 2013 8:23 am | News | Comments

Emergent BioSolutions has entered into a definitive agreement with Cangene Corporation under which Emergent will acquire all of the outstanding common shares of Cangene in an all-cash transaction valued at $3.24 per share on a fully diluted basis for an aggregate purchase price of $222 million.

Daily Dose #3: Single-Use Implementation Costs and Considerations

December 11, 2013 3:52 pm | Videos | Comments

When considering the purchase and implementation of single-use technologies there are many variables to evaluate. One important consideration is how the new single-use systems will integrate with the existing facility infrastructure.  

Compendial Water Systems - Maintenance and Monitoring Considerations

December 10, 2013 4:21 pm | by William V. Collentro, Pharmaceutical Water Specialists, LLC | Articles | Comments

Inadequate maintenance and monitoring programs for compendial water systems can result in chemical and/or microbial excursions that impact water quality. Total viable bacteria results associated with distribution loop sampling are not available for at least 3-5 days after collection. During this time an unacceptable increase in total viable bacteria could occur as a result of an operating excursion in a water purification unit operation.

FDA Grants Fast Track Designation to Navidea Biopharmaceuticals’ Lymphoseek®

December 10, 2013 8:14 am | News | Comments

Navidea Biopharmaceuticals announced today that the FDA has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.     

Surveying The Industry’s Needs

December 4, 2013 9:35 am | by Mike Auerbach, Editor in Chief | Articles | Comments

Our annual reader survey looks at issues facing innovator companies and the CMO/CSOs that support them.                        

JHL Biotech and Selexis Form Biologic Drug Development Alliance

December 3, 2013 10:44 am | News | Comments

JHL Biotech, Inc., a provider of biopharmaceutical process development and manufacturing services, and Switzerland-based Selexis SA, a provider of technologies for mammalian cell line development, announced today that they have signed a non-exclusive strategic agreement to provide biopharmaceutical customers a seamless solution for the development and cGMP manufacturing of biologic drugs.

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