Current developments in the biopharmaceutical industry have added significantly to the challenges of designing, building, and operating biopharmaceutical manufacturing facilities.
Genentech, a member of the Roche Group, has announced plans to invest more than $125 million for...
There are many nuances that require a more focused approach to risk identification and project...
The past several years have witnessed a significant increase in the rate of adoption for single...
The U.S. Food and Drug Administration has approved the first drug in the U.S. that was developed through the recently established biosimilar regulatory pathway, clearing the way for competition in that arena to commence, according to Fitch Ratings.
Biosimilar approvals in the United States are expected to increase during the next five years, but safety concerns among physicians and the need for greater regulatory clarity concerning therapeutic interchangeability could hinder market uptake, according to a study recently completed by the Tufts Center for the Study of Drug Development.
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 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.
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.
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Boehringer Ingelheim and Sanofi announced today that they enter into an alliance to extend Sanofi’s manufacturing capacity network for therapeutic monoclonal antibodies.
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.
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 ImmunotherapiesJanuary 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.
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.
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.
The Genesis 50L is an all-plastic bioprocess container designed to meet the ever evolving storage and shipping needs of the pharmaceutical industry.
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 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.
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.
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 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.
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.
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.
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 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.
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 AgreementOctober 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.
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