Bioreactors

Single-use bioreactors: 2,000L a ceiling, says new BPSA board member

17-Jan-2017 By Dan Stanton

The majority of biomanufacturers use single-use systems at least in the development stage says Entegris’ Eric Isberg, but scaling-up will always be a challenge.

AGC boasts 44,000L of biomanufacturing capacity on back of recent M&A

11-Jan-2017 By Dan Stanton

After buying two CMOs, Japanese glassmaker AGC has made “a full-fledged launch” into the biologics manufacturing space and says it will consider further M&A opportunities.

Teva aiming to be major second and third wave biosimilars company

Teva: ‘Celltrion deal will double biosimilar sales to $600m’

11-Jan-2017 By Dan Stanton

Celltrion deal and multi-million Euro German plant will make it a major second and third wave biosimilars player says Teva.

US FDA delays Ocrevus decision date asking Roche for more manufacturing data

23-Dec-2016 By Gareth Macdonald

The US FDA has pushed back the review date Roche’s Ocrevus (ocrelizumab) after asking for more data on processes used to manufacture the candidate MS treatment.

AGC expanding CDMO biz through $500m CMC Biologics buy

21-Dec-2016 By Dan Stanton

AGC Asahi Glass has signed an agreement to buy CMC Biologics, the second biologics CDMO acquisition for the Japanese chemicals firm in three months.

Univercells part of Gates-backed group trying to cut polio vaccine cost

16-Dec-2016 By Gareth Macdonald

The Bill & Melinda Gates Foundation has granted Univercells $12m (€12.5m) to develop a vaccine manufacturing platform that lowers production costs.

apceth Biopharma joins Lonza as bluebird bio cell therapy contractor

15-Dec-2016 By Gareth Macdonald

bluebird bio Inc has hired apceth Biopharma GmbH to make its candidate ALD cell therapy Lenti-D and its thalassemia treatment LentiGlobin for the European market.

MilliporeSigma to speed up production of Acticor’s antibody against stroke

07-Dec-2016 By Dani Bancroft

Acticor Biotech has made a deal with Merck KGaA’s CMO MilliporeSigma to use its Provantage End-to-End services to make its anti-thrombotic antibody fragment ACT-017 for stroke.

Sanofi makes play for Chinese biosimilars market in deal with JHL

06-Dec-2016 By Gareth Macdonald

Sanofi has teamed with JHL Biotech to develop biosimilar products, including a version of Rituxan (rituximab), for the Chinese and international markets.

Takeda building Dengue fever vaccine plant

01-Dec-2016 By Gareth Macdonald

Takeda has started work on a vaccine plant to make its candidate Dengue fever virus vaccine, TAK-003.

WuXi to make Prima proteins from new 28,000L single-use facility in China

29-Nov-2016 By Dan Stanton

WuXi Biologics will make a recombinant soluble LAG-3 protein on behalf of Prima Biomed from its 28,000L single-use facility in China set to open next year.

One down, five to go: Autolus takes space at UK cell & gene therapy centre

22-Nov-2016 By Dan Stanton

T-cell immunotherapy firm Autolus has become the first tenant at the Cell and Gene Therapy (CGT) Catapult manufacturing facility in the UK.

Mylan boasts of 16 biosimilars in portfolio after Mabion rituximab deal

11-Nov-2016 By Dan Stanton

Mylan has struck a deal to commercialise a version of Roche’s Mabthera in Europe made by Polish biotech Mabion using a 2,500L disposable bioreactor system.

Rentschler ups capacity again, with second 2,000L single-use bioreactor

08-Nov-2016 By Dan Stanton

Biologics CMO Rentschler has increased its single-use capacity by 50%, just weeks after opening a stainless steel facility at its site in Germany.

UPDATE

GE Healthcare to add capacity and automation at MA single-use tech plant

02-Nov-2016 By Dan Stanton

GE Healthcare says a $7m investment will triple clean-room capacity and add automated production lines at its single-use tech manufacturing facility in Massachusetts.

Catalent breaks ground on WI expansion to support commercial biomanufacturing

02-Nov-2016 By Dan Stanton

The $34m expansion at its Madison, Wisconsin site will support Phase III and commercial biologics production, says Catalent.

Fake drug sales mean fewer people are employed by EU drug firms says EUIPO

26-Oct-2016 By Gareth Macdonald

Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO).

China's Tot Biopharm starts work on second plant with eye on ADC market

19-Oct-2016 By Gareth Macdonald

Tot Biopharm has started work on a second monoclonal antibody (mAb) drug production plant at China’s Suzhou Industrial Park.

WuXi boosts cell therapy capacity with new PA facility

18-Oct-2016 By Staff Reporter

WuXi Apptec has opened a facility in Philadelphia offering chimeric antigen receptor T (CAR T) cell therapy manufacturing.

Biotech Week Boston

Repligen launches single-use version of its cell retention tech

14-Oct-2016 By Dan Stanton

Repligen has launched a single-use version of its XCell ATF cell retention system which can reduce implementation costs by as much as 55% compared to its stainless steel equivalent.

Merck opens testing plant in latest Korean bioprocessing investment

07-Oct-2016 By Dan Stanton

Germany’s Merck has opened a bioprocessing collaboration centre in Songdo, Incheon - the latest investment supporting the burgeoning Korean biopharma industry.

Dispatches from CPhI Worldwide

Single-use tech will impact the 'extremely consolidated' bio-CMO space, expert

06-Oct-2016 By Dan Stanton

Lonza and Boehringer-Ingelheim dominate the consolidated biologics CMO space but disposable technologies and improved yields are beginning to change this, says PharmSource’s Jim Miller.

BPI Boston

Continuous bioprocessing next logical step after single-use adoption, Pall

06-Oct-2016 By Dan Stanton

The strong adoption of single-use technology is enabling industry to transition towards continuous bioprocessing systems, says Pall Corporation.

Advocacy group criticises EC's plan for stand-alone cell & gene therapy GMP doc

30-Sep-2016 By Dan Stanton

European stand-alone guidelines for the manufacture of Advanced Therapy Medicine Product (ATMP) could lead to disparities in GMP standards, says the Alliance for Regenerative Medicine.

UPDATE

Regeneron thanks Abec for helping it avoid "gremlins" during bio plant set-up

27-Sep-2016 By Gareth Macdonald

Abec has completed work on Regeneron’s biologics facility in Ireland just 28 months after it was hired to kit out the repurposed computer plant.

Gates Foundation grant aims to reduce cost of manufacturing rotavirus vaccine

27-Sep-2016 By Dan Stanton

Fixed-bed, high cell density bioreactors and a naturally occurring attenuated viral strain will be used by Batavia Biosciences in an attempt to produce an affordable rotavirus vaccine.

Pharma 2020 has activated Russian biomanufacturing tech market says GE Healthcare

23-Sep-2016 By Gareth Macdonald

Government efforts to encourage local drug production have “activated” the Russian biomanufacturing technology market according to GE Healthcare.

Perfusion infusion: WuXi Biologics opens disposable plant as part of $150m expansion

23-Sep-2016 By Dan Stanton

WuXi has responded to a global demand for perfusion technologies by opening a commercial scale manufacturing site in China with two 1,000L disposable bioreactors.

Sartorius pledges to cut development times with upstream suite

22-Sep-2016 By Phil Taylor

Sartorius Stedim Biotech claims it has a platform that can help biopharma companies carve months off the development time for new products.

Rentschler doubles capacity with new manufacturing plant

16-Sep-2016 By Gareth Macdonald

Rentschler Biotechnologie has opened a facility at its site in Laupheim, Germany and plans to create 200 new jobs.

Promising Korea? CMO giant Samsung Biologics opens doors to Biopharma-Reporter

16-Sep-2016 By Dan Stanton

Since 2011, Samsung Biologics has built two plants, gained Bristol-Myers Squibb and Roche as clients and launched an IPO. With a third facility under construction, Biopharma-Reporter visited to see the CMO’s ambition in action.

Avid to construct third plant with two 1,000L single-use bioreactors

13-Sep-2016 By Dan Stanton

Avid Bioservices will construct a clinical manufacturing plant later this year just months after production began at a second facility.

INFOGRAPHIC

The future of the biopharma industry: emerging markets and biosimilars

07-Sep-2016 By Dan Stanton

China and India are the most important growth markets for biopharmaceutical manufacturers, according to our state of the industry survey.

INFOGRAPHIC

State of the biopharma industry: the double-edged sword of single-use

06-Sep-2016 By Dan Stanton

Biomanufacturers have fully embraced disposable technologies but the market is controlled by a handful of vendors keeping equipment costs high, our reader survey reveals.

Dispatches from Korea

Inside Celltrion: a biosimilar success story built on landfill

30-Aug-2016 By Dan Stanton

Ambition, hard work and a focus on quality has made Celltrion the ‘pioneers of the mAb biosimilar industry,’ the firm told Biopharma-Reporter during a tour of its biomanufacturing site in Songdo, Korea.

Catalent Q4 results

Catalent to add two 2,000L bioreactors in $34m WI biologics plant expansion

30-Aug-2016 By Dan Stanton

Catalent has more than doubled its biologics business since it went public in 2014, but the sector still represents less than 5% of the CDMO’s revenues.

RenovaCare looks to use skin as ‘natural bioreactor’ to treat burns

30-Aug-2016 By Dan Stanton

A device that isolates and sprays a patient’s own stem cells onto serious burns could have significant implications in the organ regeneration industry, says developer RenovaCare.

CPhI South Korea 2016

Accelerating timelines vital to securing slice of biosimilars market, KBI

24-Aug-2016 By Dan Stanton

Accelerated development gives biosimilars an upper hand in gaining market share, CMO KBI Biopharma told delegates in Korea yesterday.

Cost pressures turning pharma towards automation tech, says Zenith

23-Aug-2016 By Dan Stanton

Increased cost pressures and a shift to biologics manufacturing are driving demand for automation technologies, says Zenith which is opening two offices in the US.