Bioreactors

EMA approves production at Samsung Biologics 152,000L plant

13-Dec-2017 By Staff Reporter

The world’s largest single bioproduction plant has received its first EU regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.

Standardised single-use tech, the industry’s 'holy grail?'

06-Dec-2017 By Flora Southey

Vendors say they are open to considering a singular, industry-wide design for disposable bioreactor equipment, IP concerns and customised demands could impede its adoption.

World’s largest single-use plant begins cGMP production

06-Dec-2017 By Dan Stanton

WuXi Biologics says its 30,000L capacity single-use facility in China has commenced making products for its partner Tesaro.

ABEC: customised tech protects large single-use bags

17-Nov-2017 By Flora Southey

A pulley loading system and customised storage frame reduces damage risk to large single-use bags, says 4,000L bioreactor vendor ABEC.

Merck KGaA: Extensive uptake of single-use forced efficiency drive

10-Nov-2017 By Dan Stanton

Single-use demand grew so fast vendors were unable to keep up, says MilliporeSigma which has since tackled this through investments and a standardised offering.

InVitria launches xeno-free formulation service within $5.2bn media market

10-Nov-2017 By InVitria launches xeno-free service within $5.2bn media market

Xeno-free media will continue to increase its share of the estimated 30m litre mammalian cell culture market says InVitria, which has launched a new formulation service.

Samsung BioLogics extends supply agreement with MilliporeSigma

08-Nov-2017 By Dan Stanton

Samsung BioLogics has extended a memorandum of understanding with MilliporeSigma for supply of single-use systems and bioprocessing raw materials.

Catalent: Cook deal strengthens sub 5,000L scale CMO strategy

08-Nov-2017 By Dan Stanton

70% of the biologics pipeline will require less than 5,000L of commercial manufacturing capacity says Catalent, fresh from its acquisition of Cook.

Swiss CDMO to expand newly bought Glycotope biomanufacturing plant in Germany

07-Nov-2017 By Dan Stanton

Celonic says it will immediately begin expanding the former Glycotope site in Heidelberg, Germany adding two 2,000L single-use bioreactors.

Fujifilm adding three 2,000L GE single-use bioreactors as part of $30m expansion

06-Nov-2017 By Dan Stanton

Following a ‎¥14bn ($125m) investment in April, Fujifilm Corporation has committed a further ‎¥3.2bn across its biologics contract manufacturing business.

Pall lands WuXi fit out for mAb continuous bioprocess lab

03-Nov-2017 By Flora Southey

Pall Corporation will equip WuXi Biologics’ continuous bioprocess laboratory in Shanghai, China, which the latter said would expand process scale and reduce manufacturing costs.

Shire to sell Milford facility

Shire expects to be making some Cinryze in-house early next year

31-Oct-2017 By Gareth Macdonald

Shire has said it is on track to start making some Cinryze in-house next year to address supply problems at Dutch contractor Sanquin.

BIOPRODUCTION CONGRESS DUBLIN 2017

Integrating disposable tech? Size matters, says BMS

27-Oct-2017 By Flora Southey

Size can be a restricting factor when introducing single-use technologies into a pre-existing facility according to BMS, which hopes to integrate disposable equipment at a US-based site.

Emergent buys Abec bioreactor to transfer raxibacumab to Baltimore facility

27-Oct-2017 By Gareth Macdonald

Bioterrorism countermeasure manufacturer Emergent Biosciences has bought a 4,000L bioreactor developed by Abec.

Sartorius Stedim Biotech cuts guidance citing hurricane, destocking and supply problems

25-Oct-2017 By Gareth Macdonald

Sartorius Stedim Biotech (SSB) has cut its full year guidance, citing the negative impact of hurricane Maria, customer destocking and ongoing issues with a cell culture media supplier.

CPhI Worldwide 2017

Samsung Biologics: EU or US for fourth plant, but not China

25-Oct-2017 By Dan Stanton

Fresh from US approval of its second facility and ahead of the opening of a third, Samsung Biologics is now considering a fourth plant outside of Korea.

Pall: Quarterly set-backs but hurricanes fail to blow single-use off course

24-Oct-2017 By Dan Stanton

Pall Corporation suffered a significant impact in the third quarter after hurricanes shut down facilities in Puerto Rico and Florida.

Univercells: 'Micro-facilities' to slash the cost of vaccine manufacture

20-Oct-2017 By Cutting the cost of vaccine manufacture, Univercells

High-density single-use bioreactors, small facilities and continuous manufacturing will cut the cost of manufacturing polio vaccines down to $0.15 per dose, says Univercells.

'Luxturna' recommendation good for all AAV based gene therapies says advocacy group

18-Oct-2017 By Gareth Macdonald

The US approval recommendation for Spark Therapeutics’ blindness gene therapy voretigene neparvovec is also an endorsement of AAV delivery technologies according to the Alliance for Regenerative Medicine.

VirionHealth secures Abingworth backing to trial novel antiviral studies

17-Oct-2017 By Gareth Macdonald

VirionHealth Ltd is poised to start Phase I trials of new biological antivirals - called defective interfering particles - after receiving £13m ($15m) from private equity group Abingworth.

US FDA approves production at Samsung Biologics 152,000L plant

12-Oct-2017 By Dan Stanton

The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.

News in Brief

MilliporeSigma opens $115m life science centre in Massachusetts

11-Oct-2017 By Staff Reporter

MilliporeSigma has cut the ribbon on a life science site in Burlington that incorporates a biomanufacturing equipment education centre.

Avid selects MilliporeSigma to meet single-use trend

06-Oct-2017 By Flora Southey

Avid Bioservices has installed two MilliporeSigma Mobius 2,000L single-use bioreactors at its facility in Tustin, California, US.

Irvine Scientific expansion to offer dry powder media lots up to 7,000kg

28-Sep-2017 By Dan Stanton

Irvine Scientific has expanded its cell culture dry powder facility in California to support the projected increase of biotherapeutic production.

Biotech Week Boston

On the roadmap again: Industry to address 'never ending' bioprocessing evolution

27-Sep-2017 By Dan Stanton

The Biophorum Operations Group (BPOG) has begun working on 11 technology development projects after publishing its first roadmap, but the bioprocessing industry’s visions are forever evolving, says Sanofi-Genzyme.

Biotech Week Boston

Brammer leans on Pall for $50m cell & gene therapy plant expansions

27-Sep-2017 By Dan Stanton

The contract development and manufacturing organisation (CDMO) has selected Pall Life Sciences as its single-use equipment partner at its sites in Florida and Massachusetts.

MilliporeSigma opens Chinese bioprocessing centre to showcase tech

27-Sep-2017 By Staff Reporter

MilliporeSigma has opened a biopharma process development and technology centre in China.

US FDA approves Amgen and Allergan's Avastin biosimilar

15-Sep-2017 By Gareth Macdonald

US regulators have approved Amgen Inc’s Mvasi (bevacizumab-awwb), a biosimilar version of Roche’s monoclonal antibody (mAb) cancer treatment Avastin (bevacizumab). 

Kaneka Eurogentec to build biodrug production plant in Belgium

14-Sep-2017 By Gareth Macdonald

Kaneka Eurogentec has announced plans to build a biopharmaceutical manufacturing facility in Seraing, Belgium.

Momenta: WuXi single-use capacity expansion to support changing biosimilar demand

14-Sep-2017 By Dan Stanton

Momenta says flexibility built into its contract with WuXi Biologics will offset fluctuations in demand for global biosimilars.

Expression yourself: Win an iPad in our bioprocessing survey

12-Sep-2017 By Dan Stanton

Is plastic fantastic? Is stainless still à la mode*? Do Chinese hamsters continue to tow the cell line? Biopharma-Reporter wants your opinions for its second annual biomanufacturing survey.

China’s 3SBio enters North American market through $290m Therapure buy

05-Sep-2017 By Dan Stanton

3SBio will leverage Therapure’s downstream purification expertise to bolster its own biologics portfolio while expanding its contract biomanufacturing business and global presence.

From vendor to tender: Thermo Fisher completes $7.2bn Patheon acquisition

30-Aug-2017 By Dan Stanton

Thermo Fisher has entered the contract development and manufacturing (CDMO) space through the acquisition of Patheon.

CEO predicts fungal-based protein expression will be a 'CHO Stopper'

CHO platforms unsustainable for biopharma's future, says Dyadic

25-Aug-2017 By Dan Stanton

Industry is feeling the low yield and high cost limitations of the CHO cell line and must look to alternatives to make next-generation biological products, says fungal-based protein expression firm Dyadic International.

Vendors optimistic for future despite slowdown in growth

18-Aug-2017 By Dan Stanton

Bioprocessing suppliers have recently expressed optimism in the sector despite a slowdown in growth, and one expert believes this will drive investment in new tech and markets.

US FDA clarifies what constitutes 'minor' change to biologic production process

09-Aug-2017 By Gareth Macdonald

The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week.

Modular single-use facilities rebalance Biopharma’s capacity scales

02-Aug-2017 By Dan Stanton

Modular facilities and single-use systems are fast becoming a standard part of the bioproduction infrastructure as industry looks to mitigate future capacity constraints.

Pall: ‘More than ever, process control is a core focus area’

28-Jul-2017 By Dan Stanton

Pall Corporation has developed a control system for its single-use benchtop bioreactor and says it will continue to invest in-house for process control technologies.

Lonza envisions five new plants at Visp for modular manufacturing biz

28-Jul-2017 By Gareth Macdonald

Lonza has started work on a facility to house its new modular tech-based biomanufacturing service at its site in Visp, Switzerland.

Sartorius takes €10m hit on media sales due to Lonza's regulatory woes

26-Jul-2017 By Dan Stanton

Supply chain issues stemming from an FDA warning letter at a facility run by its partner Lonza have dampened Sartorius Stedim Biotech’s first half 2017 results.

Exclusive interview with CEO TH Kim

Samsung Biologics: Reducing COGS could double mammalian CMO use to 50%

25-Jul-2017 By Dan Stanton

Samsung Biologics wants Big Pharma to up biomanufacturing outsourcing and says lessons learned from the semiconductor industry will give it the advantage in the CMO space.

ABEC breaks the 2,000L ‘plastic ceiling’ with 4,900L single-use bioreactor

12-Jul-2017 By Dan Stanton

ABEC says its latest offering has twice the working volume of the 2,000L bioreactor systems generally deemed to be the upper limit in single-use bioprocessing.

EC says Merck and Sigma-Aldrich broke M&A procedures and could face $170m fine

06-Jul-2017 By Gareth Macdonald

German Merck and Sigma-Aldrich broke EU merger procedures and could face a fine equivalent to 1% of the combined firm's annual revenue according to the European Commission

PBL opens doors at UK bio-development centre

04-Jul-2017 By Dan Stanton

Porton Biopharma has opened a biologics characterisation and development facility at its site in the UK.

Patheon to spend $45m on manufacturing plants ahead of Thermo takeover

30-Jun-2017 By Gareth Macdonald

Patheon NV has announced it will spend $45m to expand and enhance its manufacturing network citing customer demand for more reliable, flexible and cost-efficient supply chains.

Dispatches from BioPharma Expo, Japan

Lonza expands in Asia: 8,000L single-use in Singapore, regenerative meds in Japan

30-Jun-2017 By Dan Stanton

Lonza will install four 2,000L single-use bioreactors at its Singapore facility to cater for growing demand for small to mid-volume biologics production.

Pfizer starts work on Missouri biotherapeutics R&D hub

28-Jun-2017 By Gareth Macdonald

Pfizer is building a $200m (€179m) R&D centre in Chesterfield, Missouri at which it will consolidate biotherapeutics process development operations in the region.

Takeda prepping to take over EU production of stem cell therapy from 2021

23-Jun-2017 By Dan Stanton

Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohn’s disease stem cell therapy licensed from TiGenix.

Brazilian plant to make Humira biosimilar in 'tobacco-based bioreactors'

21-Jun-2017 By Dan Stanton

A tobacco plant-based platform could make monoclonal antibodies up to 90% cheaper than mammalian systems, says Axis Biotec which is building a pilot plant in Brazil.

Single-use in Ireland on the up? GE Healthcare, Thermo Fisher and NIBRT discuss the trend

20-Jun-2017 By Flora Southey

Ireland’s “thriving biopharma industry” has traditionally employed large-scale bioreactors, however a new wave of biologics with changing production requirements is changing the trend, say industry representatives.