Fill-Finish & Packaging

CSafe launches temperature-controlled packaging for cell therapies

10-Dec-2019 By Vassia Barba

CSafe expands its cold chain offering with a series of logistics services suitable for temperature-controlled shipping of biologics.

Pharma Integrates

Industry ‘resistance’ to disruption by advanced therapeutics

06-Dec-2019 By Vassia Barba

ACG Inspection’s CEO talks about a ‘fear’ of the disruption caused by advanced medicine, which prevents big pharma companies from investing in the supply chain.

Bavarian Nordic buys two GSK vaccines for €301M upfront

30-Oct-2019 By Nick Taylor

Bavarian Nordic buys vaccines against rabies and tick-borne encephalitis from GlaxoSmithKline for €301m, with up to €495m more in milestones payments to follow.

Terumo launches automated fill-finish system for cell therapies

08-Oct-2019 By Ben Hargreaves

Terumo launches automated fill and finish system for cell therapies, aiming to eliminate the risk of contamination during manual processing.

Early manufacturing life-saving for biologics developers, says CMO exec

23-Sep-2019 By Vassia Barba

‘Talk to your CDMO early’ is the advice BioConnection gives to developers of biopharmaceuticals, suggesting that they make a reservation to ensure availability.

Merz completes construction of new plant and filling line

17-Sep-2019 By Ben Hargreaves

Merz announces that it has completed the construction of a new plant for its botulinum neurotoxin product and unveils a ‘robot-controlled’ filling line.

GE Healthcare partners to create manufacturing suite for gene therapies

17-Sep-2019 By Ben Hargreaves

GE Healthcare teams up with Germfree to create a fully integrated, expandable manufacturing solution that is geared towards the development of ‘emerging biotherapeutics’.

Mallinckrodt agrees to sell CDMO business for $250m

11-Sep-2019 By Ben Hargreaves

Amid opioid lawsuits, Mallinckrodt looks to slim down its overall business by agreeing the sale of BioVectra to HIG.

SP Scientific partners with i-Dositecno, integrates its fill-finish offering

26-Aug-2019 By Vassia Barba

SP Scientific partners with Spanish i-Dositecno to offer complete aseptic vial and syringe fill-finish lines to clients in Europe and North America.

Packager limits intra-facility travel to address ‘critical out-of-cold-storage time’

22-Aug-2019 By Maggie Lynch

Contract packaging provider Reed-Lane adds dedicated room for vial and ampule kitting to its cold chain capabilities to limit intra-facility travel and product excursion as a means of security.

Prefilled syringes market to hit $9.7bn by 2025

19-Aug-2019 By Vassia Barba

Increasing prevalence of chronic diseases and treatment with biologics is expected to boost the prefilled syringes market by 10% in the next few years.

Bayer recalls mislabeled vials of hemophilia treatment

31-Jul-2019 By Maggie Lynch

Bayer recalls vials of an antihemophilic treatment after the discovery that nearly 1,000 were mislabeled with a therapy indicated for an adult patient population.

July roundup sees flurry of partnership deals

29-Jul-2019 By Ben Hargreaves

The summer months are traditionally slow on movements across the industry, but July saw a number of manufacturing partnership deals take place as companies look ahead to product commercialization.

Fill/finish services set to grow at annual rate of over 10%

26-Jul-2019 By Ben Hargreaves

Growing demand for biologic fill/finish services will see the market develop at a fast pace moving toward 2030, with a number of companies investing heavily in the area.

Novartis and Catalent enter agreement to manufacture SMA gene therapy

18-Jul-2019 By Maggie Lynch

Catalent Biologics works with Novartis to develop and manufacture its SMA gene therapy treatment and provide manufacturing capacity, as the treatment enters the market.

NIH signs on IDT Biologika to manufacture clinical trial supply

16-Jul-2019 By Maggie Lynch

The NIH has contracted IDT Biologika to manufacture five E. coli master cell banks for BLA, IND, and Phase I/II trial supply.

Five deals reshaping the CDMO industry this year

05-Jul-2019 By Ben Hargreaves

The major trend so far in 2019 is the willingness to deploy capital to expand services in the cell and gene therapy sector, and we outline the five most significant deals thus far.

iBio activates sterile fill-finish operations for clinical stage biopharma

27-Jun-2019 By Maggie Lynch

Sterile fill-finish capabilities will be available to clinical stage customers as iBio activates its operations for biopharmaceutical products after entering a supply agreement.

UPDATED

Catalent continues expansion spree with BMS manufacturing facility

19-Jun-2019 By Ben Hargreaves

Catalent to purchase BMS’s Italian manufacturing facility to gain access to fill/finish capabilities, following several large-scale deals this year.

Single-use tech ‘reshaping’ the industry as Thermo Fisher further invests

11-Jun-2019 By Maggie Lynch

Thermo Fisher invests into bioproduction capabilities as ‘single use continues to reshape the face of the industry,’ says single-use technology executive.

First fill-finish service from iBio aims to accelerate movement to the clinic

04-Jun-2019 By Maggie Lynch

To get biologics to market faster, iBio launches sterile fill-finish operations for preclinical and clinical biologic products.

WuXi Biologics to build 1.3m-sq-ft manufacturing centre

16-May-2019 By Ben Hargreaves

WuXi Biologics announces its latest expansion, with plans for a drug development and commercial manufacturing site with a potential bioreactor capacity of 144,000L.

Vibalogics makes investment in viral manufacturing to meet increasing demand

09-May-2019 By Maggie Lynch

Vibalogics increases its single-use bioreactor and purification capacity with a new manufacturing line to meet demand for oncolytic virus and viral vector manufacturing services.

Samsung Biologics to provide CDMO support for ‘bio-venture’ firm GI Innovation

09-May-2019 By Melissa Fassbender

Samsung Biologics is providing contract development services for GI Innovation’s pipeline, with the first among five molecules to initiate development immediately, says company representative.

Merck bumps up production of MMR vaccine amid measles outbreak

08-May-2019 By Maggie Lynch

With the recent outbreak of measles in the US, the only MMR vaccine producer in the US, Merck, has increased its production to meet demand.

Sharp ‘future proofs’ manufacturing with facility investment

06-May-2019 By Maggie Lynch

Sharp invests $21m to meet growing demand by expanding its capacity for packaging services at its Allentown, PA campus.

Brammer acquisition bolsters Thermo Fisher place in the market

29-Mar-2019 By Maggie Lynch

Thermo Fisher’s $1.7bn acquisition bolsters its ‘already strong position’ in the cell and gene therapy market, with increased CDMO capabilities.

Ajinomoto continues $100m investment to build out worldwide services

26-Mar-2019 By Ben Hargreaves

Aji Bio-Pharma will add a flexible fill line, packaging and labelling equipment to its worldwide manufacturing network, in an investment worth upwards of $100m.

Single-use technology ‘simplified’ in Pall Biotech partnership

26-Mar-2019 By Maggie Lynch

Pall Corporation collaborates with ARTeSYN Biosolutions for single-use components and fluid management technologies.

Biocon receives Form 483 due to risk of contamination

13-Mar-2019 By Ben Hargreaves

The US FDA issues Biocon a Form 483 with two observations, including failure to establish proper aseptic practices and lack of follow-up on data discrepancies.

‘Can you manufacture consistently?’ The big question in regenerative medicine

11-Mar-2019 By Ben Hargreaves

Regenerative medicine raised $13.3bn in funds during 2018 but investors question whether treatments can be manufactured consistently, according to AMR annual report.

Krystal moves towards ‘full integration’ with gene therapy facility opening

07-Mar-2019 By Ben Hargreaves

Krystal opens cGMP facility for the clinical and commercial manufacture of its lead drug candidate, KB103, and plans to open its second in 2020.

GE continues slim down with $21bn sale of BioPharma business

25-Feb-2019 By Ben Hargreaves

GE announced a change of plans regarding its GE Healthcare business, choosing to sell off the BioPharma business for $21.4bn rather than initiate an IPO.

Five reasons biologics contract manufacturing will hit $87.6bn by 2027

25-Jan-2019 By Ben Hargreaves

The contract market for bringing biologics through the pipeline to commercialisation is growing at a rapid clip, with a recent report suggesting a high CAGR in the sector.

Catalent to double biomanufacturing capacity with $200m investment

10-Jan-2019 By Ben Hargreaves

Catalent will use the funds to enlarge drug substance manufacturing and drug product fill/finish capacity.

Catalent expands biologics facility, to create 36 new jobs

04-Dec-2018 By Maggie Lynch

Catalent is expanding its US biologics packaging facility, following recent investments and expansions in the Asia-Pacific region.

Q&A

UK cell and gene therapy ecosystem ‘second to none’

26-Nov-2018 By Ben Hargreaves

The UK has a ‘rich and vibrant’ advanced therapeutic manufacturing sector well placed to attract companies post-Brexit, says Keith Thompson, CEO of CGTC.

UK invests to streamline manufacture of next-gen medicine

23-Nov-2018 By Ben Hargreaves

Funding of £7.3m will be provided across three initiatives, with the long-term aim of providing patients with access to cell and gene therapies at a faster rate.

Rentschler opens GMP fill/finish facility in Austria

21-Nov-2018 By Staff Reporter

Aseptic fill/finish contractor Rentschler Fill Solutions inaugurated the new facility in Austria’s eastern town of Rankweil.

ADC Bio secures funding to further manufacturing plans

16-Nov-2018 By Ben Hargreaves

The company announced an investment of £2.5m to design its downstream formulation and filling operations.

GE Healthcare strengthens single-use manufacturing in China

09-Nov-2018 By Ben Hargreaves

GE Healthcare will manufacture single-use consumables for bioprocessing through a collaboration with Wego.

Coherus receives US FDA approval for Neulasta biosimilar, pricing 33% lower

09-Nov-2018 By Ben Hargreaves

The company will launch Udenyca onto the US market on January 3, 2019, to compete with Amgen’s originator product and Mylan’s rival biosimilar.

BIO Europe 2018

#BIOEurope: ‘Deal making is off the charts and the IPO window is open’

08-Nov-2018 By Flora Southey

Denmark played host to its first BIO Europe this week, welcoming 4,500 attendees from across the globe – including growing numbers from China and South Korea.

CAR-T manufacture ‘where mAbs were in the early 1990s’, says bluebird CTMO

05-Nov-2018 By Ben Hargreaves

With cell and gene therapies developing at a rapid pace, it leaves significant questions as to how manufacturing processes are keeping up.

Avid expansion to triple process development capacity, says CEO

25-Oct-2018 By Ben Hargreaves

Avid continues its transition to a fully-fledged CDMO by transforming its process development capabilities with new lab space.

Shire opens $1.2bn, six-years-in-the-making facility

23-Oct-2018 By Ben Hargreaves

Shire’s immune globulin infusion-producing facility will increase the company plasma manufacturing capacity by one third.

Sarepta Therapeutics enters manufacturing partnership for DMD treatment

17-Oct-2018 By Maggie Lynch

Sarepta Therapeutics signed a long-term, strategic manufacturing partnership with Paragon Bioservices to produce micro-dystrophin to grow its gene therapy program.

US FDA approves the manufacturing of rare lung disease treatment

16-Oct-2018 By Maggie Lynch

Therapure was granted approval for the manufacture of Insmed Incorporated’s drug Arikayce at its Missassauga, Canada facility.

Lonza expands manufacturing sites for larger ADC payloads

16-Oct-2018 By Maggie Lynch

Lonza Pharma & Biotech will expand two of its manufacturing sites to reach the capabilities necessary to produce compounds bio-conjugates through to commercialization.

mAb developer Oncobiologics launches CDMO business

15-Jun-2018 By Melissa Fassbender

Oncobiologics has launched a CDMO business to provide mAb development and manufacturing capabilities in a small biotech company setting, says CFO.