Fill-Finish & Packaging

Vibalogics expands German fill/finish site on back of clinical demand

02-Sep-2016 By Dan Stanton

German CDMO Vibalogics has upped its capabilities 300% citing a lack of worldwide capacity for biologics fill and finish.

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.

Piramal: $53m Ash Stevens addition ‘synergistic’ with ADC business

18-Aug-2016 By Dan Stanton

The acquisition of Ash Stevens and a US high potent API facility will bolster Piramal’s antibody-drug conjugate offerings, the Indian CDMO says.

Cell preservation reliability: Bellicum inks 10-year deal with Biolife

10-Aug-2016 By Dan Stanton

Cell therapy firm Bellicum Pharmaceuticals has entered a ten-year agreement for the supply of BioLife Solutions’ cryopreservation media.

update

US FDA raises concerns about Alexion's Rhode Island Soliris facility

09-Aug-2016 By Gareth Macdonald

The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.

UK regulators OK two Oxford Biomedica sites for cell therapy processing

01-Aug-2016 By Gareth Macdonald

The MHRA has granted Oxford Biomedica permission to develop and manufacture cell therapies at two more sites in the UK.

Single-use, manifold benefits: Parker adds UK production capacity for bioprocessing tech

29-Jul-2016 By Gareth Macdonald

Parker domnick hunter has added manufacturing capacity at its facility in Birtley, UK to better supply European biopharmaceutical industry customers.

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.

Kite opens commercial CAR T-cell plant ahead of anticipated 2017 therapy launch

28-Jun-2016 By Dan Stanton

Kite Pharma has opened a T-cell manufacturing facility in California it says can overcome the logistical problems of autologous therapies and treat up to 5,000 patients per year.

Novartis to bring biomanufacturing ‘all under one roof’ with $1bn Sandoz investments

21-Jun-2016 By Dan Stanton

Novartis will continue investing in its manufacturing network to support a biologics pipeline which includes five new biosimilars it expects to launch by 2020.

Ajinomoto Althea gets US patent for fast, industrial-scale antibody crystallization method

19-May-2016 By Gareth Macdonald

Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.

BioLife high on cell therapy opportunities for its media and logistics services

13-May-2016 By Dan Stanton

BioLife Solutions has partnered with transportation firm MNX and says it expects increased demand for its biologistics services as more cell therapies enter the clinic.

Shire: ‘Baxalta brings us world-class manufacturing network’

03-May-2016 By Dan Stanton

Shire will retain Baxalta’s biologics expertise and continue assessing its manufacturing network following the completion of its $32bn acquisition, expected next month.

Merger prepares for 'tidal wave' of gene therapy products

31-Mar-2016 By Melissa Fassbender

Brammer Biopharmaceuticals and Florida Biologix have merged to create a cell and gene therapy biologics CDMO in preparation for a “tidal wave” of gene therapy products.

GE calls on diagnostics systems firm LeukoDx for cell characterization tech

25-Mar-2016 By Gareth Macdonald

LeukoDx will develop a cell characterization system for GE Healthcare in a deal designed to bolster the latter’s cell therapy manufacturing technology offering.

Vetter breaks ground at new $79m production building

23-Mar-2016 By Melissa Fassbender

The global contract and manufacturing organization (CDMO) announced the construction at a ground breaking ceremony held at its Ravensburg Schuetzenstrasse site. 

Korea stock? Celltrion stores Remicade biosimilar but minimises risks

22-Mar-2016 By Dan Stanton

Celltrion’s supply chain and warehousing procedures ensure the safe storage of Remicade biosimilars as demand fluctuates across markets, the drugmaker says.

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.

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

Short shelf-life poses problems for cell therapy makers, Chiesi

19-Feb-2016 By Dan Stanton

The shelf life of a cell therapy product is crucial in determining a firm’s manufacturing strategy according to the makers of the first approved stem-cell based drug.

Symbiosis growing on aseptic demand from US biotech

17-Feb-2016 By Dan Stanton

A robust investment environment and high quality demands have driven US biotech business to UK-based sterile manufacturer Symbiosis, the firm says.

Dispatches from Cell Therapy Manufacturing & Gene Therapy Congress

Vendors must collaborate to develop cell therapy production automation, experts

04-Feb-2016 By Dan Stanton

Cell therapy development and production will not be sustainable unless there is a vendor-led shift to automated processes, said experts in Brussels yesterday.

Thawing market heats up: Biocision expands cell therapy tech offering

29-Jan-2016 By Gareth Macdonald

Biocision has revamped its cell thawing platform to accommodate larger vial sizes and started developing an automated system for cell therapies in cryopreservation bags.

Regulatory reforms to reshape drug manufacturing in China says expert

28-Jan-2016 By Dan Stanton

More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.

Amatsigroup buys Q Biologicals in 'fragmented' EU bio-services space

27-Jan-2016 By Dan Stanton

French CDMO Amatsigroup will offer complete biologics development services and expand its European presence through the acquisition of Q Biologicals.

GE teams with Canadian Gov to set up C$40m cell therapy tech centre

13-Jan-2016 By Gareth Macdonald

GE Healthcare has teamed up with the Canadian Government and the Toronto-based Centre for Commercialization of Regenerative Medicine develop cell therapy manufacturing technologies.

Biologic makers looking to delivery devices to gain competitive edge, Bespak

05-Jan-2016 By Dan Stanton

Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.

Dengvaxia approval vindicates €350m 'industrial risk' says Sanofi Pasteur

11-Dec-2015 By Gareth Macdonald

Sanofi Pasteur says Mexican approval for Dengvaxia vindicates the ‘industrial risk’ it took when it invested €350m in a dengue fever vaccine plant in 2009.

Unilife undecided on takeover plans; gives December 31 deadline

10-Nov-2015 By Fiona BARRY

Unilife CEO Alan Shortall yesterday confirmed the drug delivery company is still “receiving interest from several parties under the strategic review process” and set a deadline of December 31 to announce any potential takeover.  The company received its...

Single use

GE ships pre-built plant to China as Asia pursues homemade production

06-Nov-2015 By Fiona BARRY

As GE ships the world’s largest ready-made biomanufacturing plant to China, the team involved tells us modular facilities are in demand from southeast Asian governments – and could hold the key to future pandemic treatments.

Novo Nordisk $175m diabetes plant to create 450 jobs

04-Nov-2015 By Fiona BARRY

Novo Nordisk is building a 2.1bn Danish kroner ($175m) insulin and obesity drug plant in Denmark set to employ 450 people.

Bioprocess International

There’s more to single-use than switching to bags, says Amgen

27-Oct-2015 By Fiona BARRY

Changes to biologics manufacturing will have to go beyond swapping steel vats for single-use to adapt to future industry needs, says Amgen’s drug development expert.

CPhI Worldwide 2015

Profile of a CEO: Piramal Chief shares M&A plans

21-Oct-2015 By Fiona BARRY

Piramal chief executive Vivek Sharma won last week’s CPhI award for the pharma industry’s CEO of the year. Outsourcing-Pharma.com spoke to Sharma about his plans for the CDMO the day after the jury’s unanimous decision.

Regeneron pumping a further $350m into ex-Dell Irish biologics plant

19-Oct-2015 By Dan Stanton

A $350m investment will make Regeneron’s Limerick plant “the largest-scale bulk biologics production facility in Ireland,” the firm says, and add a further 200 jobs.

Dispatches from CPhI

Catalent to expand biologics facility to keep up with capacity demand

14-Oct-2015 By Dan Stanton

Catalent says it is contemplating expanding its Wisconsin single-use biologics facility as strong demand from SMEs and biotechs has almost filled current capacity.

Final designs for UK Gov-backed facility 'weeks away' says Cell Therapy Catapult CEO

13-Oct-2015 By Gareth Macdonald

The CEO of Cell Therapy Catapult says technical designs for the new UK biomanufacturing centre will be completed in the next few weeks.

M+W contracted to build cell therapy facility by UK Government

09-Oct-2015 By Gareth Macdonald

M+W has been contracted to build a £55m ($84m) manufacturing site that will support cell and gene therapy developers by the UK Government project, Cell Therapy Catapult.

Novartis injects €150m in Austrian biologics fill/finish facility

18-Sep-2015 By Dan Stanton

The €150m ($172m) investment has added extra capacity to Novartis’s biosimilar and proprietary biologics network.

Many possible suitors for Pfizer’s biosimilar Infliximab, but no clear leader yet

01-Sep-2015 By Dan Rosenberg

Pfizer’s planned divestiture of its infliximab biosimilar candidate could create a race among competitors to gain access to the product, but in the early going, no clear leader has emerged.

TxCell: we’ll continue to use CMO even after we get back our GMP

04-Aug-2015 By Fiona BARRY

French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.

Stem cell factories: New substrate opens door to mass produced regenerative therapies

24-Jul-2015 By Gareth Macdonald

Mass produced regenerative therapies are a step closer say UK researchers who have developed a polymer substrate they claim can be used to set up “stem cell factories.”

Sartorius sees revenue and sales growth in 1H and raises full year forecast

21-Jul-2015 By Gareth Macdonald

Sartorius finished the first half of 2015 with increased sales, higher operating profits and a surge in orders that prompted it to raise its full year forecast.

Agilent and A*STAR to develop glycan analysis methods more suited to commercial setting

17-Jul-2015 By Gareth Macdonald

Agilent and A*STAR have partnered to create quicker, more accurate ways of testing the sugar content of therapeutic proteins and monoclonal antibodies (mAbs) that are tailored for commercial producers.

Sartorius buys Cellca for process dev knowhow

07-Jul-2015 By Gareth Macdonald

Sartorius Stedim Biotech SA (SSB) has acquired cell line and process development contractor Cellca GmbH.

UK’s MHRA helps ‘future-proof’ Fujifilm’s mammalian cell culture manufacturing facility

26-Jun-2015 By Zachary Brennan

In a rare move for the UK’s MHRA (Medicines and Healthcare products Regulatory Agency), the regulator has helped to “future-proof” CMO Fujifilm Diosynth Biotechnologies’ mammalian cell culture manufacturing facility in Billingham, UK against potential...

|Dispatches from ACHEMA

Regulators play catch up with ever more complex manufacturing processes

18-Jun-2015 By Dan Stanton

EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.

Lonza to build viral therapy plant in Texas

17-Jun-2015 By Gareth Macdonald

Lonza will build a viral therapy production site in Houston, Texas in a bid to capture a share of the growing gene therapy market.

update

EIB loans Poland's biggest drugmaker €45m to develop biosimilars

10-Jun-2015 By Gareth Macdonald

The European Investment Bank (EIB) has loaned Polpharma €45m to fund development of biosimilars and improve access to medicines in Europe.

Netherlands to help India develop, mass produce measles-rubella vaccine

10-Jun-2015 By Zachary Brennan

The Netherlands and India have signed a MOU (Memorandum of Understanding) under which a government-based institute of the Netherlands will extend technical support for the development and manufacturing of the measles-rubella vaccine.