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The Lead

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...

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...

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...

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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.

Sutro Biopharma and Celgene Corporation Enter Multi-Year Strategic Collaboration and Option to Acquire Agreement

October 23, 2014 10:31 am | News | Comments

The scope of the collaboration allows the parties to systematically interrogate the immuno-oncology space, including established targets, using Sutro’s cell-free biologics development platforms. During the collaboration, after an initial period, Celgene will have the exclusive option to acquire Sutro, including rights to all Sutro-owned programs at that time, on pre-specified terms.

Pharmaceutical Processing's October 2014 Issue

October 20, 2014 11:34 am | Digital Editions | Comments

The October issue of Pharmaceutical Processing describes Capsugel’s merger with Bend Research and Encap to create a comprehensive solid dosage form solutions group. The issue also features articles on supply chain trends including how to reduce risk, managing a clinical supply chain,  a look at the best printing and coding solutions, and the move to the fully connected enterprise. Other articles focus on particle size analysis, disposable chromatography technologies, and monitoring potency assays.

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Finesse Solutions Announces SmartFactory for Optimized Deployment of Single-Use Facilities

October 8, 2014 9:29 am | News | Comments

Finesse Solutions has announced the launch of SmartFactory, which is a uniquely configurable design architecture for single-use facilities. The Finesse SmartFactory is based on Finesse SmartParts, the measurement and actuation building blocks which comprise SmartSystem process automation solutions.

Pharmaceutical Processing's September 2014 Issue

September 29, 2014 1:48 pm | Digital Editions | Comments

  The September issue of Pharmaceutical Processing profiles SAFC’s new dry powder media manufacturing facility in Irvine, Scotland. In addition, coverage includes articles on highly toxic manufacturing and containment/isolator technologies. We also have a report on how CMOs are leading the adoption of new biopharm technologies. Other articles include a look at aseptic primary packaging, the challenges of scale-up and commercialization, optimizing vaccine processes, and the state of track and trace in the industry.  

SAFC and Baxter BioPharma Solutions to Collaborate on ADC Offering

September 24, 2014 11:16 am | News | Comments

SAFC will contribute extensive expertise in conjugation and the manufacture of drug linkers, while BioPharma Solutions will offer world-class, sterile fill/finish services for final filling of ADC products.        

A Tale of Two Cities - SAFC's Irvine, Scotland and Lenexa, KS Dry Powder Media Facilities

September 11, 2014 1:38 pm | by Mike Auerbach, Editor In Chief | Articles | Comments

SAFC, a global company that supplies a multitude of services to the biopharm/pharmaceutical industry has recently opened a new Dry Powder Media (DPM ) manufacturing facility in Irvine, Scotland to complement their Lenexa, KS DPM facility. By doing so SAFC has shown their commitment to their customers and this growing segment of the pharmaceutical industry.

Baxter Announces Baxalta as the Name of New Global Biopharmaceutical Company

September 11, 2014 8:37 am | News | Comments

Baxter International has announced that Baxalta Incorporated will be the name of the new, publicly traded biopharmaceutical company that is expected to launch in mid-2015.             

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AMRI Expands Services to Protein Market

September 4, 2014 9:07 am | News | Comments

AMRI announced today that it has expanded into the protein market, with an initial focus on protein expression and purification. The global revenue of the total proteomics market is anticipated to grow at a compound annual growth rate of about 4.1% to about $9.2 billion by 2018.

Ajinomoto Althea Receives European GMP Certification

September 3, 2014 9:13 am | News | Comments

Ajinomoto Althea announced today that it has officially received its European GMP certificate issued by the MHRA. The MHRA conducted an on-site inspection on June 19, 2014 that yielded no critical or major observations. This certification provides clearance to Althea to test commercial drug product for the European market.

Novo Nordisk Buys Production Plant in New Hampshire

August 28, 2014 11:47 am | News | Comments

The facility was established in 1989, expanded in 2003-2006 and acquired by Olympus Biotech in 2011. It has been used primarily for mammalian cell manufacturing until production was phased out earlier this year.       

EMD Millipore Announces Strategic Alliance with Samsung BioLogics

August 26, 2014 2:34 pm | News | Comments

The alliance is intended to encompass a long-term supply agreement in which EMD Millipore will provide raw materials for biopharmaceutical manufacturing.                

PhRMA Launches New Innovation Hub to Highlight Biopharmaceutical Innovation

August 26, 2014 9:08 am | News | Comments

PhRMA launched a new Innovation Hub to showcase the latest data and research on innovation in the biopharmaceutical industry. The new Innovation Hub, accessible via www.Innovation.org, provides easy access to PhRMA resources related to the R&D process, the biopharmaceutical pipeline, and progress fighting diseases.

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EMD Millipore Expands Biomanufacturing Sciences and Training Center in Japan and Opens New Location in Tokyo

August 26, 2014 8:14 am | News | Comments

EMD Millipore today announced the opening of a new Biomanufacturing Sciences Training Center (BSTC) facility in Tokyo. The facility is designed to help biopharmaceutical companies develop manufacturing processes and find solutions to processing challenges in collaboration with engineers from EMD Millipore.

GE Healthcare Appoints General Manager of Asia Commercial BioProcess

August 13, 2014 8:40 am | News | Comments

GE Healthcare Life Sciences today announced the appointment of Olivier Loeillot as General Manager, Asia Commercial for BioProcess.  In this newly-created role Olivier will oversee commercial activities in the fast-moving Asian market for GE Healthcare Life Science’s rapidly growing BioProcess business.

BioProcess Technology Consultants Promotes Two to Principal Consultants

August 11, 2014 9:14 am | News | Comments

Bioprocess Technology Consultants, Inc. (BPTC), a technical, and regulatory consulting company for the global biopharmaceutical industry, has promoted Susan Dana Jones, Ph.D., and Thomas C. Ransohoff to Principal Consultants.     

Allied Minds and BMS Form Enterprise to Advance Discoveries of Biopharmaceutical Innovations

August 4, 2014 8:32 am | News | Comments

Allied Minds and Bristol-Myers Squibb Company today announced the formation of Allied-Bristol Life Sciences LLC, a new jointly owned enterprise created to identify and foster research and pre-clinical development of biopharmaceutical innovations from leading university research institutions across the U.S.

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 double-digit revenue growth and a sharp increase in funds raised. However, much of the industry's growth was driven by a relatively small group of commercial stage companies, increasing the urgency for the rest of the industry to achieve greater efficiency in their drug development efforts.

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 the "assembly line" within microorganisms that naturally produces antibiotics and other drugs.                            

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 market beyond 2019, despite an initial projected Compound Annual Growth Rate (CAGR) of 8.3%, taking the overall biologics market value from $162 billion in 2013 to more than $262 billion by 2019, says research and consulting firm GlobalData.

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. 

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.

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