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The Lead

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...

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...

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-...

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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.

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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.

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.

Single-Use Film

October 21, 2014 11:48 am | by Nikita Ernst, Associate Editor | Product Releases | Comments

 PureFlex™ Plus film is a robust, durable film used in the construction of Mobius single-use process containers for biopharmaceutical manufacturing.

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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.

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.        

Catalent and Cingulate Therapeutics to Develop New ADHD Treatments

September 23, 2014 3:09 pm | News | Comments

Catalent Pharma Solutions has reached an exclusive development and licensing agreement with privately held biopharmaceutical company, Cingulate Therapeutics, to support the development of a series of new prescription pharmaceutical products for the treatment of ADHD using Catalent’s OSDrC® OptiDose™ drug delivery platform.

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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.             

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.

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.

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.

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