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The Lead

Developing Flexibility and Efficiency in Biomanufacturing Facilities

March 27, 2015 8:05 am | by Jeff Odum, CPIP, Biopharmaceutical Market Leader, IPS | News | Comments

Current developments in the biopharmaceutical industry have added significantly to the challenges of designing, building, and operating biopharmaceutical manufacturing facilities.

Genentech Announces Plans to Expand Hillsboro Facility

March 26, 2015 3:26 pm | News | Comments

Genentech, a member of the Roche Group, has announced plans to invest more than $125 million for...

Managing the SUS-Based Facility Design

March 25, 2015 8:31 am | by Jeff Odum, CPIP, IPS-Integrated Project Services, Inc. | Blogs | Comments

There are many nuances that require a more focused approach to risk identification and project...

Single Use Disposables: Risk Reduction AND Operational Flexibility – Too Good to be True?

March 23, 2015 8:59 am | by Robert Roy, IPS | Blogs | Comments

The past several years have witnessed a significant increase in the rate of adoption for single...

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Bill Would Require HPV Vaccine for Nevada School Enrollment

February 4, 2015 3:44 pm | by MICHELLE RINDELS, Associated Press | News | Comments

A bill introduced this week in the state Senate would require Nevada preteens to be immunized against meningitis and the sexually transmitted human papillomavirus before they enroll in public or private school or daycare, potentially raising Nevada's below-average HPV vaccination rate.

Contract Manufacturers Unlikely to Benefit from Biosimilars

January 30, 2015 9:45 am | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

Contract pharmaceutical manufacturers are unlikely to benefit from the rise of generic biological drugs in the U.S., according to an analysis by PharmSource. The company said large drug companies and those with significant commercialization and manufacturing partnerships are likely to dominate the initial market for those drugs, called biosimilars -- leaving out companies relying on contract manufacturing.

3M In-home Needles Eligible for Clinical Trials

January 28, 2015 1:27 pm | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

3M has announced its system of microscopic needles is now eligible for use in clinical trials. The Minnesota-based conglomerate's Hollow Microstructured Transdermal System aims to allow patients to receive injection prescription medications at home via a series of microneedles.

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Report: Single-Use Bioreactors Market to Grow to $471M by 2019

January 28, 2015 8:02 am | News | Comments

The single use bioreactors (SUBs) market is expected to grow at a double digit CAGR of 18.4% to reach $470.9 million by 2019 from $202.5 million in 2014. Developing markets such as China and India are lucrative markets for single-use bioreactors (SUB), owing to the low cost benefits offered by these nations.

12th Annual Biopharmaceutical Manufacturing Report and Survey

January 27, 2015 11:47 am | News | Comments

Your input is important as BioPlan Associates, Inc., benchmarks global and regional trends affecting our industry.  You will receive a FREE summary of the results of this important global study; our 159 Key Industry Facts White Paper; AND for each completed survey BioPlan will donate $10 (up to $10,000) to global health charities.

Catalent Biologics and MGC Pharma Announce Partnership for Biomanufacturing in Asia

January 19, 2015 12:29 pm | News | Comments

Catalent Pharma Solutions and Mitsubishi Gas Chemical Company, Inc. (MGC), have entered into a partnership agreement to co-promote Catalent’s proprietary GPEx® technology in the Asian market.          

Five Quick Questions: Biosimilar Regulatory and Intellectual Property Issues

January 15, 2015 1:50 pm | by Andrew Szal, Editor, Pharmaceutical Processing | Articles | Comments

As biologic drugs like Humira and Enbrel become a larger and larger part of the pharmaceutical market, a new report from attorneys at Goodwin Procter says the introduction of lower-cost generic versions called “biosimilars” may be close at hand. 

Boehringer Ingelheim and Sanofi to Collaborate on Manufacturing Biopharmaceuticals

January 15, 2015 8:34 am | News | Comments

Boehringer Ingelheim and Sanofi announced today that they enter into an alliance to extend Sanofi’s manufacturing capacity network for therapeutic monoclonal antibodies.              

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AMRI to Develop and Manufacture Parenteral Products for Genovi Pharmaceuticals

January 12, 2015 8:51 am | News | Comments

AMRI will initially provide cGMP manufacture and analytical support for the registration of five product candidates. AMRI will be reimbursed for technology transfer activities, analytical development and manufacture of regulatory submission batches. In addition, AMRI is eligible to receive additional payments for achieving product delivery milestones.

LSNE Receives Approval To Manufacture Commercial Aseptic Product

January 7, 2015 8:08 am | News | Comments

Lyophilization Services of New England, Inc. (LSNE) announced today that following an FDA Pre-Approval Inspection (PAI) in November 2014, their Harvey Road manufacturing site has received approval to manufacture commercial drug product for US distribution.

Saint-Gobain to Supply Argos Therapeutics with Disposables to be Used in Automated Manufacturing of Fully Personalized Immunotherapies

January 6, 2015 8:37 am | News | Comments

Under the terms of the agreement, Saint-Gobain will partner with Argos to design, integrate and scale production of a range of disposables for use in the automated manufacturing of Argos' lead product candidate, AGS-003, currently being tested in a Phase III clinical trial for the treatment of metastatic renal cell carcinoma.

Biotech and Generic Drugs: 2015 Trends and Predictions

December 9, 2014 4:05 pm | by Ed Price, President of PCI | Blogs | Comments

Ed Price, President of PCI Synthesis, issues his annual list of trends that he feels will continue to affect the emerging biotech and generic drug industries in 2015.                        

Lab Bioreactor for Process Development

December 8, 2014 3:47 pm | Product Releases | Comments

The stainless steel fermenter/bioreactor BIOSTAT® Cplus is designed for the cultivation of microorganisms and cell cultures. Typical fields of application include process development for the production of biopharmaceutics, vaccines, biofuels and secondary metabolites, the optimization of batch, fed-batch, continuous and perfusion processes as well as scale-up and scale-down experiments.

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Folding Plastic Bioprocess Containers

December 8, 2014 2:39 pm | Product Releases | Comments

The Genesis 50L is an all-plastic bioprocess container designed to meet the ever evolving storage and shipping needs of the pharmaceutical industry.

How Single-Use, Mini Bioreactors Could Revolutionize Bioprocess Scale-Up

November 25, 2014 10:53 am | by Mwai Ngibuini, ambr250 Product Manager, Sartorius Stedim Biotech | TAP Biosystems | Articles | Comments

With new mAb drugs such as Kadcyla costing over 100,000 Euros per year, the price per patient for these therapies is considerably more than small molecule drug treatments. One reason for this is that these therapies cost more to manufacture than small molecules. By using mini scale bioreactor models to determine optimum scale-up bioprocess parameters in fed-batch culture could speed up process development and reduce manufacturing costs.

Vetter Opens Singapore Office to Support Growing Asian Healthcare Market

November 20, 2014 8:42 am | News | Comments

Vetter has announced the opening of a new representative office in Singapore. The announcement was made at a ceremony attended by members of local government agencies and a number of executives of pharmaceutical/biotech companies with a presence in the Asian region, as well as Vetter executives.

Clean Room Wall Pass-Through System

November 18, 2014 1:46 pm | Product Releases | Comments

AdvantaPass is used to transfer large volumes of fluids between clean rooms during pharmaceutical and biopharmaceutical production. The system maintains the separation of room atmospheres and minimizes cross contamination risks.

BMS to Construct a New Large-Scale Biologics Manufacturing Facility in Cruiserath, Ireland

November 17, 2014 8:31 am | News | Comments

Bristol-Myers Squibb Company has announced plans to construct a new state-of-the-art, large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland, that will produce multiple therapies for the company’s growing biologics portfolio.

Pharmaceutical Processing’s Nov/Dec 2014 Digital Issue

November 13, 2014 11:13 am | Digital Editions | Comments

Pharmaceutical Processing’s Nov/Dec 2014 issue features an in-depth look at SAFC’s recently expanded high-potency API manufacturing facilities in Madison, WI. In addition, our Annual CMO/CSO Survey is included in this issue detailing the trends driving the CMO/CSO market. Other articles take a look at elastomeric closure in parenteral manufacturing, cleanroom energy efficiency, package integrity, deduster design efficiency, and desiccant canister design and feeding options.

Vent Option on Capsule Filter for Use in Critical Sterile Processes

November 12, 2014 3:57 pm | Product Releases | Comments

The Sterile Process Design (SPD) vent has been optimized for use in critical single-use sterile filtration processes and offers a number of new features. The large knurled knob is easy to actuate with gloved hands, while multi-turn flow initiation allows for precise metering of flow during venting operations.

The Biosimilars Market

October 31, 2014 11:19 am | by Sarfaraz K. Niazi, Ph.D., Founding Chairman and CEO, Therapeutic Proteins International | Articles | Comments

Biosimilars have increasingly become an important and somewhat controversial topic in the healthcare space. Depending on who one speaks to, the opinion on biosimilars changes. However, there are certain truths that all stakeholders should keep in mind.

High Potency, High Reward

October 31, 2014 10:43 am | by Nikita Ernst, Associate Editor | Articles | Comments

SAFC, a global supplier of a a wide range of services to the biopharm and pharmaceutical industry, has recently expanded their Madison, Wisconsin facilities to neighboring Verona to rev up their high-potency API manufacturing capabilities.

Bristol-Myers Squibb and Lonza Expand Manufacturing Agreement

October 30, 2014 1:34 pm | News | Comments

Bristol-Myers Squibb and Lonza have announced a multi-year expansion of their existing biologics manufacturing agreement. The contract expansion will include the production of commercial quantities of a second Bristol-Myers Squibb biologic medicine at Lonza’s mammalian manufacturing facility in Portsmouth, NH.

Instantaneous Microbial Detection for Pharmaceutical Water Monitoring

October 29, 2014 11:34 am | Product Releases | Comments

The IMD-W™ rapid microbial detection system is designed for applications where the instrument can be used immediately to manage and mitigate risks, increase process understanding, save energy through better use of heat sanitization cycles, and drive labor efficiencies.

The Flexible Filling Line: The Crossover Vehicle for Aseptic Manufacturing

October 29, 2014 8:59 am | by Paul Valerio, Director, Technology at IPS - Integrated Project Services | Blogs | Comments

People want it all, don’t they?  The type of cars many drive is one indicator.  Crossover vehicles have become a very popular vehicle segment.  They offer: practicality while still maintaining a cool factor; spaciousness with decent fuel efficiency; and car-like handling with the safety of all wheel drive for slippery conditions.

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