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The Lead

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. 

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...

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...

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...

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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.

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.

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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.

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.

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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.                   

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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.

Daily Dose: Single Use, Multiple Benefits

December 3, 2013 8:03 am | Videos | Comments

One of the reasons for the strong adaption rate of single use systems stems from the ability to implement such an approach at a number of different points in the production process. While there are still some limitations in terms of large-scale production, as the technology has evolved single use has translated to areas like mixing, purification, formulation and even filling as processors look to take advantage of the cost and time savings

JHL Biotech Selects GE’s FlexFactory™ Biomanufacturing Platform for Taiwan Facility

December 2, 2013 8:37 am | News | Comments

GE Healthcare Life Sciences, and JHL Biotech today announced that GE Healthcare has completed installation of its FlexFactory™ biomanufacturing platform at JHL Biotech’s Research Center and manufacturing plant in Hsinchu, Taiwan.  The new manufacturing platform will follow current good manufacturing practices (cGMP) and be fully operational by the end of 2013.

The Daily Dose: Exploring Single-Use Technology

November 26, 2013 8:59 am | Videos | Comments

This first episode of The Daily Dose from Pharmaceutical Processing discusses the technology driving single use systems and why this methodology has had such an impact. Two specific benefits discussed here include limiting cross-contamination risk and reducing changeover times.

Protein Purification System

November 25, 2013 2:26 pm | Ge Healthcare Uk Limited | Product Releases | Comments

Ready-to-go straight from the box, ÄKTA start is a compact, affordable protein purification system that removes the hassles of manual approaches and provides automated control of the purification procedure.

Stratus Media Group Acquires Two Biopharmaceutical Companies

November 21, 2013 8:15 am | News | Comments

Stratus Media Group, Inc., announced today the closing of its acquisition of two biopharmaceutical companies - Canterbury Laboratories, LLC, and Hygeia Therapeutics, Inc.            

Restricted Flow and Shut-Off Valves

November 20, 2013 2:45 pm | Product Releases | Comments

BioValves are designed to minimize flow path turbulence and be used single handed. Molded from glass reinforced Nylon USP Class VI, the thread pitch is calibrated to 2mm per turn, ensuring accurate fluid transfer rates.

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