Bioreactors

Japanese biotech adopts MES at recombinant flu vaccine plant

15-Aug-2014 By Zachary Brennan

Japanese biotech company Unigen has implemented in only four months Werum's PAS-X Manufacturing Execution System (MES), which can help optimize production output at the world’s largest plant for the contract manufacturing of recombinant flu vaccines.

Kentucky firm ramps production of plant-based antibodies used to treat two Ebola patients

06-Aug-2014 By Zachary Brennan

Two Americans stricken with the Ebola virus in Liberia were flown back to the US following treatment with an unapproved treatment manufactured from tobacco plants in Kentucky. Manufacturing of the treatment is expected to ramp up as the patients improve.

Redbiotec picks GE's single-use systems for Herpesvirus vaccine production

05-Aug-2014 By Dan Stanton

Redbiotec has selected GE Healthcare’s single-use processing offering to aid development of its Herpesvirus vaccines which use viral antigen complexes and virus-like particles. 

UK to set up personalised meds focused manufacturing tech test centre

11-Jul-2014 By Gareth Macdonald

A new UK “biologics facility of the future” (FoF) testing centre will let biopharma tech firms develop smaller-scale manufacturing systems for personalised medicine production according to the Centre for Process Innovation (CPI).

Rentschler expands manufacturing capacity again, this time with stainless steel

01-Jul-2014 By Zachary Brennan

The Laupheim, Germany-based CMO (contract manufacturing organization) Rentschler Biotechnologie has invested €24m ($33m) to build a twin stainless steel bioreactor system. 

Fujifilm buys TAP bioreactor for UK manufacturing plant

27-Jun-2014 By Gareth Macdonald

Fujifilm Diosynth Biotechnologies has expanded process development capacity at its site in the UK with a new $5.6m investment and a TAP bioreactor.

Govt-backed cell therapy centre will help UK firms reach market says CTC

25-Jun-2014 By Gareth Macdonald

A new cell therapy development centre has opened at Guy’s Hospital in London today in the latest stage of a Government-backed effort to establish the UK as a global hub.

Dispatches from BIO

Genzyme offers inside look at Massachusetts plant under consent decree

25-Jun-2014 By Zachary Brennan

More than four years after Genzyme was issued a consent decree by the FDA at its biomanufacturing facility in Allston, Massachusetts, and the company is still completing its remediation efforts and will be for the years to come.

SAFC to make virus-resistant cell lines

24-Jun-2014 By Fiona Barry

BioReliance and its parent company SAFC say they are working on viral-resistant cell lines that will prevent contamination in bioreactors.

Dispatches from BIO 2014

Kalon building $91m vaccine manufacturing facility in Texas for GSK partnership

24-Jun-2014 By Zachary Brennan

Texas-based Kalon Biotherapeutics is in the process of building two new biomanufacturing facilities, including a $91m facility to produce flu vaccines for GlaxoSmithKline. 

Rentschler doubles capacity with new single-use bioreactor

10-Jun-2014 By Zachary Brennan

German CMO Rentschler Biotechnologie GmbH is adding a 2,000 L single-use bioreactor to its facility in Laupheim, Germany, which it expects to be fully operational by the end of the first quarter of 2015.

PacificGMP doubles production capacity with GE bioreactor

06-Jun-2014 By Zachary Brennan

CDMO (contract development and manufacturing organization) PacificGMP has doubled its GMP (good manufacturing practice) production capacity with the addition of a second System 1000 bioreactor platform from GE Healthcare. 

Repligen 'Refines' high yield fermentation system in $25m acquisition

04-Jun-2014 By Dan Stanton

Repligen has added the “gold standard” of fermentation cell retention technology to its portfolio, and says it will develop it further to support the rise in single-use.  

Pall up on downstream as ATMI boosts sales but cuts margin

30-May-2014 By Dan Stanton

Pall says the acquisition of ATMI helped grow biopharmaceuticals sales 13% year-over-year, but negatively impacted gross margin for the third quarter.

Biopharma wary of disposable systems for large-scale production... for now

28-May-2014 By Dan Stanton

Janssen has mirrored Pfizer’s concerns about the scale, price and robustness of using single-use technology for high-volume production but says industry collaboration could help bring standards in place.

Pfizer nabs Roslin Cells in cell therapy manufacturing deal

23-May-2014 By Zachary Brennan

Roslin Cells has signed a contract with Neusentis, a research unit of Pfizer based in Cambridge, UK, to support the manufacture of retinal pigment epithelium (RPE) cells to be used in a cell therapy clinical trial.  

Cytovance to scale up mAb for Selexys’s Phase I trial

16-May-2014 By Fiona BARRY

Cytovance will use both single-use and stainless steel in its monoclonal antibody (mAb) manufacturing deal with Selexys Pharmaceuticals.

KBI Biopharma acquires Merck’s biomanufacturing facility in Colorado

15-May-2014 By Zachary Brennan

KBI Biopharma has agreed to acquire Merck’s microbial process development and manufacturing operations in Boulder, Colorado. 

DISPATCHES FROM THE BIOLOGICAL PRODUCTION FORUM, DUBLIN

Pfizer stays stainless saying single-use cost burdens high volume production

14-May-2014 By Dan Stanton

Single-use technology for high volume biomanufacturing is riddled with problems and will only be fully implemented by industry once the cost drops, according to Pfizer.

CMC to manufacture cancer mAb for MacroGenics

14-May-2014 By Fiona BARRY

CMC Biologics, a contract manufacturing organization (CMO), has been picked by biopharmaceutical company MacroGenics to make its oncology candidate as "an extension of their own technical team."

Novartis talks stem-cells but no word on Gamida rumours

13-May-2014 By Dan Stanton

Novartis says stem cell-based therapies will form an important part of its pipeline after reports in the Israeli media the firm pulled out of a deal to buy Gamida Cell.

Gallus enters cell line optimization, manufacturing agreement with Omni Bio

06-May-2014

CMO Gallus BioPharmaceuticals and Omni Bio Pharmaceutical jointly announced finalization of a multi-stage manufacturing services agreement.

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.

B-MS, Samsung extend biologics manufacturing agreement

25-Apr-2014 By Zachary Brennan

Bristol-Myers Squibb and Samsung Biologics have expanded their existing agreement in which Samsung will manufacture several unnamed biologics at its Incheon, South Korea manufacturing site. Financial terms of the agreement were not disclosed.

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.

Sanofi sells therapy cells: Aastrom buys products and plants

22-Apr-2014 By Gareth Macdonald

Aastrom Biosciences will pay Sanofi $6.5m (EUR4.7m) for its cell therapy business in a deal that gives the cash strapped regenerative medicines developer three commercial products.

Thermo Fisher: new pumps compatible with all bioprocessing techs

16-Apr-2014 By Gareth MACDONALD

Thermo Fisher has launched a pump technology designed for applications across the bioprocessing production line and usable with "all" bioprocessing tech.

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.

Kyowa Hakko Kirin completes $60m mammalian plant with 12,000L bioreactor

08-Apr-2014 By Dan Stanton

Kyowa Hakko Kirin has completed construction of a ¥6bn ($60m) biomanufacturing plant in Japan boasting a 12,000L stainless steel mammalian bioreactor.

Cobra's French mAb customers to get R&D tax credit

01-Apr-2014 By Gareth Macdonald

French mAb developers that hire Cobra Biologics stand to benefit from tax breaks after the French Ministry of Higher Education and Research (MESR) named the CMO as a preferred provider.

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....

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.

Applikon's China plant and future Asian hub up and running

14-Mar-2014 By Gareth Macdonald

Applikon Biotechnology BV has already made 50 bioreactor systems at a new plant in China, which it plans to expand into its Asian manufacturing HQ.

EMD Millipore wins $400K grant from Massachusetts for Promethera partnership

14-Mar-2014 By Zachary Brennan

In what may be an early indication of states looking to get more involved in biologic development, EMD Millipore has won a $400,000 grant from the Massachusetts Life Sciences Center (MLSC) to fund a partnership with Promethera Biosciences.

GE rolls out new animal-free hMSC growth medium with cost saving claim

11-Mar-2014 By Gareth Macdonald

GE Healthcare has launched a new cell culture medium that it claims will let manufacturers skip lengthy validation steps and achieve greater batch to batch consistency.

BMS's 'industrial evolution' blow to Irish small molecule plant

11-Mar-2014 By Dan Stanton

Ireland is seeing a renewed interest from biotech, the Industrial Development Agency (IDA) says, as Bristol-Myers Squibbs shuts a Dublin API plant to focus on biopharmaceuticals.

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.

Pall follows Thermo Fisher, Sartorius trend for single-use tech

26-Feb-2014 By Fiona Barry

Pall has completed its acquisition of ATMI LifeSciences, making it the latest firm to strengthen its single-use bioreactor portfolio.

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.

Advaxis nabs SynCo Bio for manufacturing of its lead cancer immunotherapy

25-Feb-2014 By Zachary Brennan

Biotech Advaxis has selected CMO SynCo Bio Partners B.V to manufacture Advaxis' potential cervical cancer immunotherapy.

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. 

Cytovance to manufacture Pamlico Biopharma antibodies

19-Feb-2014 By Zachary Brennan

CMO Cytovance Biologics has entered into a manufacturing agreement with Pamlico Biopharma to develop a group of three human IgG monoclonal antibodies intended for the treatment of Streptococcus pneumoniae infections. 

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.

Pluristem gets German approval for cell therapy manufacturing process

04-Feb-2014 By Gareth Macdonald

German regulators have approved a 3D manufacturing process that Pluristem Therapeutics claims can produce cell therapies faster and more cheaply than standard methods.

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.