Bioreactors

MilliporeSigma investing $115m in new North American hub

19-Jul-2016 By Melissa Fassbender

The 280,000-square-foot facility will be built in Burlington, Massachusetts and will include a customer collaboration laboratory and training center, in addition to office space.

EMA accepts third Samsung Bioepis biosimilar for review

19-Jul-2016 By Gareth Macdonald

The EMA has said it will assess Samsung Bioepis’ version of Humira (adalimumab), which is the third biosimilar the (currently) London-based agency has accepted for review.

GE Healthcare backed research could make stem cell production faster and cheaper

13-Jul-2016 By Gareth Macdonald

A human plasma protein could make producing pluripotent stem cells cheaper and faster according to academics in the UK and Sweden and partner GE Healthcare.

Update

Pfizer and GE team on $350m modular biosimilars plant in China

28-Jun-2016 By Dan Stanton

Pfizer has struck a strategic partnership with GE Healthcare to construct and equip a biomanufacturing centre focused on producing biosimilars for China.

update

Janssen accuses Celltrion's media supplier HyClone of patent infringement

24-Jun-2016 By Gareth Macdonald

Janssen says culture media HyClone Laboratories makes for Celltrion infringe on a US patent covering broths used in the manufacture of Remicade (infliximab).

Amgen confirms it is working on a version of Alexion's drug

Amgen developing Soliris biosimilar

21-Jun-2016 By Gareth Macdonald

Amgen has started a trial of a biosimilar version of Alexion Pharmaceuticals’ Soliris (Eculizumab).

Pfizer breaks ground on new biologics clinical manufacturing facility

17-Jun-2016 By Melissa Fassbender

Pfizer broke ground on its new Andover, MA-based biologics clinical manufacturing facility this week, which will feature single-use and disposable technologies.

Sartorius: Upstream filter offers 'virus insurance' for biomanufacturers

15-Jun-2016 By Dan Stanton

Virus filters have traditionally been used in downstream processes, but Sartorius’s Virosart Media for upstream is a gamechanger, the firm says.

Cash-strapped Epirus to sell CHO platform and biosimilar IP to Polpharma for $3.5m

15-Jun-2016 By Dan Stanton

As part of a cost-savings restructure, Epirus is selling the assets from its $14m acquisition of Bioceros last September to its biosimilars partner Polpharma.

BIO 2016

Technology, not capacity, driving Catalent’s biologics strategy

14-Jun-2016 By Dan Stanton

Differentiated technologies buoyed by the recent $600m conjugation deal with Roche is driving Catalent’s biologics business, the firm told Biopharma-Reporter at BIO.

Cristália gets ANVISA nod to make burns treatment at new biomanufacturing plant

10-Jun-2016 By Gareth Macdonald

Brazil’s ANVISA has cleared Cristália Laboratory to make an API for an over-the-counter (OTC) burns treatment at a recently established $40m biomanufacturing facility in Itapira, Sao Paulo.

Dispatches from BIO

Dedicated or condominium? Patheon talks 'creative' capacity models at BIO

08-Jun-2016 By Dan Stanton

With problems in forecasting capacity demand, biopharma is looking to a number of new models from third-party manufacturers according to Patheon.

CORRECTION - Dispatches from BIO 2016

Merck & Co. and Fujifilm team to share capabilities at new $60m microbial plant

07-Jun-2016 By Dan Stanton

A new $60m facility at a MSD site in Ireland will offer Fujifilm Diosynth customers 20,000L of microbial biologics capacity in a collaboration between the two firms.

Breaking the single-use paradigm? CMC Biologics to offer 12,000L scale runs

03-Jun-2016 By Dan Stanton

Single-use manufacturing runs have been limited to 2,000L, but CMC Biologics says it will be able to offer 12,000L of commercial scale through its bioreactor configuration platform.

UPDATE

New tech will drive single-use shift in microbial sector, says Eppendorf

01-Jun-2016 By Dan Stanton

Eppendorf has launched a stirred-tank, rigid-wall bioreactor it says can help address single-use challenges in microbial applications.

Inflectra-maker Celltrion to expand biosimilar capacity by 170,000L

27-May-2016 By Dan Stanton

Celltrion will invest $275m at its biosimilar production site in Korea to ramp up capacity from 140,000L to 310,000L by 2021.

CGT to test scaffold tech for commercial-scale T-cell production

25-May-2016 By Gareth Macdonald

The UK Cell and Gene Therapy Catapult (CGT) will test a “scaffold” technology its Australian developers say could make T-cell production more efficient.

Islexa to grow islets in lab to make transplants available to more Type I diabetes patients

18-May-2016 By Gareth Macdonald

A new UK company plans to grow pancreatic islets in the lab to enable more Type I diabetes suffers to receive transplants.

JHL Biotech opens single-use plant based on GE's modular tech

13-May-2016 By Melissa Fassbender

The world’s largest modular cGMP biopharmaceutical manufacturing facility came online this week in Wuhan, China.

MilliporeSigma: increasing ease of use for single-use tech

28-Apr-2016 By Melissa Fassbender

MilliporeSigma showcased several products at Interphex this year in New York, including its Mobius 1000 liter single-use bioreactor.

BPI Europe 2016

Pall: Bioprocessing's future is made of virtual reality

27-Apr-2016 By Dan Stanton

Pall Corporation has embraced a virtual reality platform to showcase some of its bioprocessing systems at industry shows.

Lonza to invest in existing mammalian cell culture facilities after strong Q1

27-Apr-2016 By Gareth Macdonald

Lonza plans to expand mammalian cell culture-based drug and viral manufacturing capacity after growth in both businesses helped it to record first quarter sales.

Brexit bad for biosimilar developers says new industry group

22-Apr-2016 By Gareth Macdonald

Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).

Sartorius pumping over €100m into production network to support growth

22-Apr-2016 By Dan Stanton

Sartorius will invest around 10% of its annual revenues into its manufacturing network to support continued double-digit growth of its bioprocessing equipment business.

Single-use and Stainless steel: Hybrid technologies the future of drug production says expert

20-Apr-2016 By Gareth Macdonald

Single-use is the future but stainless steel bioreactors will always play a role in drug production says an expert, who thinks firms could do worse than consult a CMO before deciding in which technology to invest.

Pluristem in talks with large Japanese firm interested in cell therapy pact

19-Apr-2016 By Gareth Macdonald

Pluristem is in partnership talks with a large Japanese pharmaceutical firm interested in its cell therapies for hematopoietic diseases.

Pluristem gets Japanese patent for 3D cell culturing method

15-Apr-2016 By Gareth Macdonald

Placenta-derived cell therapy developer Pluristem Therapeutics has been granted patents covering 3D culturing methods by the Japan Patent Office.

Dispatches from BPI Europe 2016

Steel crazy after all these years? Bioprocess industry talks facility of future

13-Apr-2016 By Dan Stanton

Stainless steel systems have become the niche single-use was five years ago, but could a shift to continuous manufacturing drive its return?

Asymptote to commercialize in clinic cell therapy thawing tech

08-Apr-2016 By Gareth Macdonald

Asymptote plans to launch a point-of-care thawing system for cell therapies it developed with Cell and Gene Therapy Catapult (CGTC).

Eppendorf addressing stem cell scale-up challenges in Horizon 2020 project

08-Apr-2016 By Dan Stanton

Eppendorf will tackle the challenges of scaling-up human induced pluripotent stem cells (hiPSCs) as part of a Horizon 2020 project to develop cell-based heart therapies.

US Gov: Critical need for reproducible regenerative med manufacturing processes

06-Apr-2016 By Dan Stanton

Cell therapy firms must invest in engineering and learn from biopharma according to the US Government, which says high cost of regenerative treatments is slowing uptake.

US FDA approves Celltrion's Remicade biosimilar

06-Apr-2016 By Melissa Fassbender

The FDA has approved its first biosimilar mAb, Remsima – a Remicade biosimilar from Celltrion.

BMS teams with Ireland's NIBRT to strengthen biomanufacturing processes

30-Mar-2016 By Dan Stanton

Bristol-Myers Squibb has announced plans to set up a biomanufacturing process laboratory in collaboration with Ireland's National Institute of Bioprocessing Research and Training (NIBRT).

Biogen ups biologics capacity 73% through extra 144,000L at new Swiss plant

25-Mar-2016 By Dan Stanton

Biogen will equip its new Swiss biomanufacturing plant with eight 18,000L stainless steel bioreactors supplied by ABEC.

Hitachi Chemical licenses PCT tech and mulls cell therapy JV

23-Mar-2016 By Gareth Macdonald

Hitachi Chemical has licensed cell therapy manufacturing technology from PCT in a deal that may see the firms set up a European JV.

GSK partners with Miltenyi Biotec to target CAR T cell therapy automation

18-Mar-2016 By Dan Stanton

GSK says the collaboration will attempt to overcome scale-up issues, a major concern among cell and gene therapy developers.

Time-saving benefit a factor in decision to go disposable, says Avid

16-Mar-2016 By Dan Stanton

The changeover time between batches is significantly quicker using disposable equipment, says Avid Bioservices whose new biomanufacturing facility boasts several 1,000L single-use bioreactors.

3D culturing key to bone marrow therapy for Fukushima clean-up workers

11-Mar-2016 By Gareth Macdonald

A bone marrow therapy available to workers cleaning up after the Fukushima nuclear plant meltdown relies on a novel bioreactor tech that cultures cells in 3D.

Peregrine: new biologics plant may boost contracting revenues by $40m

08-Mar-2016 By Gareth Macdonald

Avid Bioservices has formally commissioned a biologics manufacturing facility that more than doubles its production capacity.

Ginkgo Bioworks: mini-bioreactor will speed expansion into pharma

08-Mar-2016 By Gareth Macdonald

Industrial microorganism design firm Ginkgo Bioworks expects to cut six months off development timelines using mini-bioreactor technology supplied by Sartorius Stedim Biotech (SSB).

32 tonnes, 8,500km, 18 months: JHL says off-the-shelf mAb plant to open in June

01-Mar-2016 By Gareth Macdonald

A mAb plant fabricated in Germany and shipped to China last year will be operational this summer according to Wuhan-based JHL Biotech.

JHL completes assembly of GE built off-the-shelf plant in Wuhan, China

29-Feb-2016 By Gareth Macdonald

JHL has completed “mechanical construction” of an off-the-shelf mAb plant in Wuhan, China days after UK regulators gave the go ahead for a trial of its rituximab biosimilar, JHL1101.

Cell Therapy Manufacturing & Gene Therapy Congress - Brussels, Belgium

Pall's Xpansion bioreactor chosen for 'world's largest cell bank' scale-up

23-Feb-2016 By Dan Stanton

Scaling-up without expanding its manufacturing footprint was key in selecting Pall's Xpansion bioreactor, says UCL which is looking to create “the world’s largest therapeutic cell bank.”

Dispatches from Cell Therapy Manufacturing & Gene Therapy Congress

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