Disposable Manufacturing Tech

Wuxi to equip new cell therapy plant with single-use systems

02-May-2014 By Zachary Brennan

WuXi PharmaTech says it has no intention using stainless steel tanks at its new cell therapy manufacturing facility in Philadelphia, Pennsylvania.

Sartorius acquires AllPure to fill gaps in single-use portfolio

29-Apr-2014 By Dan Stanton

Sartorius Stedim Biotech has acquired a majority stake in single-use systems start-up firm AllPure Technologies.

Quality of Life shown in robust Q1 for Thermo Fisher

23-Apr-2014 By Dan Stanton

Q1 revenues for Thermo Fisher’s Life Sciences Solutions business shot up 384% year-over-year in a quarter that saw the integration of Life Technologies.

Integrity test helps assure no flaws in single-use systems, says ASI

09-Apr-2014 By Dan Stanton

ASI has developed a last-chance confidence test for single-use biomanufacturers looking for assurance there are no flaws in their bioreactor bags.

Austrianova picks A*STAR microfluidics platform for cell dispensing

04-Apr-2014

Cell transportation technology firm Austrianova has licensed a low-cost, disposable microfluidics platform from SIMTech to improve how it dispenses cells used in biomanufacturing and therapeutic applications.

Continuous chromatography tech part of 'facility of the future,' says Novasep

02-Apr-2014 By Dan Stanton

Novasep has reported a 14 percent growth in its biopharma business driven in part by demand for downstream manufacturing and its continuous chromatography systems.

UK scientists announce breakthrough in stem cell manufacturing

02-Apr-2014 By Zachary Brennan

Scientists at the University of Nottingham have created a new combination of hydrogels that allows dense tissue structures to be produced from human pluripotent stem cells (HPSC) in a single step process never achieved before.

dispatches from interphex

Integrating single-use into existing facilities still a challenge, says ASI

28-Mar-2014 By Dan Stanton

Integrating single-use systems into existing facilities is still a challenge to the adoption of such technologies, according to ASI.

Cytovance extends mAb manufacturing agreement with Precision Biologics

28-Mar-2014 By Zachary Brennan

CMO Cytovance Biologics is extending its manufacturing agreement with Precision Biologics to advance clinical trials with its leading monoclonal antibody candidate, which is being developed as a therapeutic candidate for pancreatic and colorectal cancers....

UPDATE

Indiana biosimilar switching requirements become law

26-Mar-2014 By Gareth Macdonald

Industry group BIO has commended Indiana Governor Mike Pence for signing laws that will mean doctors must give pharmacists permission to switch a biologic for a biosimilar.

DISPATCHES FROM INTERPHEX

So far, so very good: Pall and ATMI talk integration at interphex

21-Mar-2014 By Dan Stanton

While there will always be space for stainless steel systems, single-use technology is now mainstream according to Pall and ATMI.

DISPATCHES FROM INTERPHEX

To QbD or not to QbD? For biologics it's a must says Cook Pharmica expert

19-Mar-2014 By Dan Stanton

The thorny issue of applying QbD to biopharmaceutical manufacture is a topic of hot debate at Interphex 2014 according to CMO Cook Pharmica.

Start spreading the news, Interphex opens today

18-Mar-2014

When Frank Sinatra sang "If you can make it there, you can make it anywhere" in New York, New York he probably wasn't talking about biopharmaceutical production.

Prima BioMed begins plans to scale up immunocellular manufacturing platform

18-Mar-2014

After making significant investments in its personalized immunocellullar manufacturing technology, Prima BioMed is looking to scale up the platform as the company’s lead product enters Phase II trials.  

Pall: Single-use skyrockets but stainless steel still shines

28-Feb-2014 By Dan Stanton

Uptake in single-use is “off the charts” but there is still a growing market for traditional stainless steel technology, says Pall following its acquisition of ATMI.

Watson-Marlow buys Bio Pure for Biopharma business

26-Feb-2014 By Gareth Macdonald

Watson-Marlow Pumps Group (WMPG) has bought single-use connection technology developer Bio Pure Technology in a deal designed to bolster its biopharmaceutical manufacturing portfolio.

GE Healthcare granted patent for disposable bioprocess ID tags

25-Feb-2014

GE Healthcare has received patent approval for a system which prevents illegal manufacturing and unauthorized operation of disposable bioprocess components.

Pfizer, MIT in 3-year collaboration focusing on biologics manufacturing

25-Feb-2014 By Zachary Brennan

Pfizer and MIT have announced a new three-year collaboration to advance biopharmaceutical discovery using synthetic biology. 

US FDA offers guidance on analytical procedures and methods validation for biologics

21-Feb-2014 By Zachary Brennan

The US FDA has issued draft guidance to help the biopharmaceutical industry assemble information and present data to support its analytical methodologies. 

Shire's single-use MA plant receives US FDA approval to make VPRIV

18-Feb-2014 By Dan Stanton

The US Food and Drug Administration (FDA) has approved a second facility for Shire to manufacture its Gaucher disease drug VPRIV.

Life Tech takeover gives Thermo 'leading brands' says analyst

04-Feb-2014 By Gareth Macdonald

Thermo Fisher Scientific completed its takeover of Life Technologies last night, just two days after the US Federal Trade Commission (FTC) approved the $13.6bn deal. 

Double biologics expansion for CMOs Gallus and Cytovance

31-Jan-2014 By Fiona Barry

Contract manufacturers Cytovance and Gallus have both invested millions of dollars in expanding their biologics-manufacturing facilities.

Thermo Fisher: 'Life begins in February,' as it awaits FTC approval

31-Jan-2014 By Dan Stanton

Thermo Fisher has predicted its $13.6bn takeover of Life Technologies will be completed in February as it reports strong FY 2013 results.

Nanotherapeutics opts for GE’s modular manufacturing platform

22-Jan-2014

US defence contractor Nanotherapeutics will use a modular biomanufacturing system provided by GE Healthcare at a facility it is building in Alachua, Florida.

Pall CEO: ATMI deal doesn't rule out other acquisitions

21-Jan-2014 By Dan Stanton

Buying ATMI will help Pall fill gaps in its up and downstream biomanufacturing tech offerings but the deal does not rule out other acquisitions says CEO, Larry Kingsley

China OKs $13bn Life Tech takeover but insists on Thermo price cuts

15-Jan-2014 By Gareth Macdonald

Chinese authorities have given Thermo Fisher Scientific the green light to buy Life Technologies on the condition it discounts certain products sold in the coutry.

HyClone units to keep Utah and Colorado HQs says GE Healthcare

08-Jan-2014 By Gareth Macdonald

GE Healthcare has confirmed it will continue to run the HyClone units it is buying from Thermo Fisher Scientific from their existing US bases.

UPDATE

ATMI sells bioreactor biz to Pall following strategic review

23-Dec-2013 By Dan Stanton

Pall Corporation has acquired ATMI’s Life Science Business for $185m (€135m).

Sartorius sets out plans for Ambr after Tap takeover

20-Dec-2013 By Gareth Macdonald

Sartorius has confirmed it will make the Ambr microreactor technology it acquired with Tap Biosystems compatible with its own downstream processing systems.

Alvotech's $250m Icelandic plant will use disposable tech for mAb biosimilars

11-Dec-2013 By Dan Stanton

Alvogen has branched into biomanufacturing with plans to build a $250m (€182m) facility in Iceland to produce biosimilar monoclonal antibodies. 

Cobra says the right tech strategy can cut lead times

02-Dec-2013 By Gareth Macdonald

Choosing the same biomanufacturing tech supplier for development and commercial systems cuts scale steps and reduces lead times according to Cobra Biologics.

Genetically engineered rice proves to produce high yields of rotavirus-specific antibody

29-Nov-2013 By Zachary Brennan

Researchers recently genetically engineered rice to produce high yields of an antibody that proved effective in a study to treat and prevent rotavirus-induced gastrointestinal symptoms in mice.

TAP approves Sartorius $45m takeover bid

22-Nov-2013

UK-based fermentor maker TAP Biosystems has approved the €33m ($45m) takeover bid by Sartorius.

Orgenesis and ATMI partner in diabetes cell therapy Belgian subsidiary

08-Nov-2013 By Dan Stanton

Orgenesis has partnered ATMI and established a subsidiary in Belgium in order to manufacture cells for clinical trials of its insulin-producing regenerative drug.

Repligen ups disposable chromatography column capacity

06-Nov-2013 By Zachary Brennan

US biopharma company Repligen has completed a 9,000 square foot expansion of its facilities in Massachusetts to meet growing customer demand for disposable chromatography columns and warehousing.

DSM's cGMP biologics plant a boon to Australian biotech, firm says

30-Oct-2013 By Dan Stanton

DSM says its new biomanufacturing facility will benefit the Australian biotech sector, overcoming the problems of distance with foreign contract manufacturers.

Pall opens Centre of Excellence in Shanghai

25-Oct-2013 By Dan Stanton

Pall has opened of a Centre of Excellence (CofE) in Shanghai for both local and international customers.

Nanotherapeutics to invest $122m to make biologics for US military

25-Oct-2013

Biologics firm Nanotherapeutics has started work on a new facility that will produce biological countermeasures for the US military.

Gilead to expand sofosbuvir plant days after positive US FDA review

25-Oct-2013 By Gareth Macdonald

Gilead will spend $47m (Eur 34m) to expand a Canadian plant at which it produces biopharmaceuticals for trials, including its Ph III hep C drug candidate sofosbuvir.

report from Biotechnica

Better single-use cross flow techs still needed says GE Healthcare

16-Oct-2013 By Gareth Macdonald

The biopharmaceutical manufacturing sector needs better cross flow filtration technologies according to GE Healthcare, which says that advances in bioreactor systems have not been matched downstream.

news from Biotechnica

New Pall single-use TFF tech attracts attention

11-Oct-2013 By Gareth Macdonald

A new filter tech developed by Pall Life Sciences attracted a lot of attention at the Biotechnica trade show in Germany this week with some attendees describing it as the industry's first truly ‘single-use’ TFF module.

EDITOR'S BLOG

Plastic not fantastic but single-use is still greener, says industry

04-Oct-2013 By Dan Stanton

Plastic may be greener than stainless steel, but industry still needs to find a more recyclable alternative for biomanufacturing systems according to Greenpeace.

US flu vaccine manufacturing network looks to increase capacity by 20%

04-Oct-2013 By Zachary Brennan

The US Department of Health and Human Services has awarded almost $40m (29m Euros) in contracts to four contract flu vaccine manufacturers as part of an effort to increase fill and finish capacity by 20%.

Carbogen Amcis invests in ADC capacity

02-Oct-2013

Carbogen Amcis AG has become the latest CMO to invest in antibody drug conjugate (ADC) production.

GE to build disposable biopharmaceutical factory for JHL Biotech in China

27-Sep-2013 By Zachary Brennan

GE Healthcare Life Sciences has agreed to build a modular biopharmaceutical factory in China for JHL Biotech, which could be a model for ways to grow local manufacturing in emerging markets. 

Agilent splits up to create two separate businesses

20-Sep-2013

Agilent Technologies has officially separated its biopharma service offerings from its electric measurement group to create two separate companies, the life science portion of which is expected to bring in about $3.9B in FY2013.

MIT’s biomanufacturing program wins $10M US defense contract

20-Sep-2013 By Zachary Brennan

The US Defense Advanced Research Projects Agency (DARPA) has awarded MIT’s Biomanufacturing Research Program (BioMAN) a $10.4 million grant from to develop devices and techniques to more rapidly produce biologics. 

ATMI Invests in Medinstill Sterile Fill Tech

18-Sep-2013

Single-use biopharma provider ATMI has invested in sterile connector and fill technology developed by Medical Instill Technologies.

Eppendorf Gets US Patent for ‘Unopenable’ Bioreactor

13-Sep-2013 By Gareth Macdonald

Eppendorf claims its new bioreactor design overcomes the contamination risk associated with more easily opened systems.

EDITOR'S BLOG

BioPharma Tech Firms Can Help Prevent Bioweapon Production, Says UN

11-Sep-2013 By Gareth Macdonald

Making germ warfare weapons is banned under the Biological Weapons Convention (BWC) and there is no evidence signatories or even countries led by any of the World’s crackpot dictators/freedom fighters* are producing them.