Facilities

Rubius Therapeutics to build $155m facility in Rhode Island

04-Jul-2018 By Ben Hargreaves

Rubius Therapeutics says it will invest $155m over five years in a new manufacturing facility and biotech operations in Rhode Island, US.

Sanofi expands R&D in China with €66m Chengdu Hub

03-Jul-2018 By Flora Southey

Sanofi will support development of polypeptides, gene therapy, monoclonal antibodies and multi-specific antibodies through the expansion of its R&D plant in Chengdu, Sichuan province, China.

Entegris: Growing demand for single-use tech drives Flex Concepts buy

03-Jul-2018 By Flora Southey

Entegris says buying Flex Concepts will help secure its supply of disposable bioprocessing bags and fluid transfer technologies.

Shire to scale up workforce after plasma facility wins US FDA approval

28-Jun-2018 By Ben Hargreaves

Shire has received US FDA approval to produce gammagard liquid solution at its Covington, Georgia plant.

UPDATE

Mustang Bio brings CAR T development in-house

26-Jun-2018 By Ben Hargreaves

Mustang Bio has revealed that it has opened a new 27,000-square-foot facility in Worcester, Massachusetts, to develop its own CAR T-cell therapies.

CellGenix expands cell culture reagent facility in Germany, plans filling/freeze-drying line

22-Jun-2018 By Flora Southey

CellGenix has added quality control and R&D laboratories as well as logistics and warehouse space to its headquarters in Freiburg, Germany.

Jefferson Institute for Bioprocessing: Site plan and launch update

19-Jun-2018 By Flora Southey

The Jefferson Institute for Bioprocessing is set to launch in spring 2019, in Jefferson University’s new Spring House Innovation Park.

IDA Ireland: Low corporate tax rate here to stay, ‘difficult’ to say same for US

15-Jun-2018 By Flora Southey

The Republic of Ireland’s competitive corporate tax rate represents a ‘stability’ that may not be found in other economies, says IDA Ireland executive.

Parker details investment timeline, launches new single-use system

12-Jun-2018 By Melissa Fassbender

Parker Bioscience outlines its planned investment to meet demand as the industry shifts from traditional processes to biological – for which single-use products are critical, says exec.

GE grows FlexFactory presence in China with another cell therapy plant deal

08-Jun-2018 By Flora Southey

GE Healthcare has announced plans to install its second FlexFactory manufacturing platform for cell therapy, this time at Xiangxue Pharmaceutical’s site in Guangzhou, China.

Novartis invests $55m in US gene therapy site, prepares BLA

01-Jun-2018 By Flora Southey

AveXis – a Novartis company – has added a manufacturing facility in North Carolina to its site network, where it will make investigational therapies for neurological genetic diseases.

Personalized medicine driving biobanking demand, says sample management provider

29-May-2018 By Melissa Fassbender

The growing emphasis on personalized medicine is driving the need for biobanking services – demand for which is expected to continue increasing.

Fujifilm expands fill/finish services for gene therapies in Texas

29-May-2018 By Flora Southey

Fujifilm Diosynth Biotechnologies has added fill/finish capabilities for late-phase and commercial supply of gene therapies and viral vaccines.

UK invests in cell and gene therapy workforce to prepare for commercial products

29-May-2018 By Nick Taylor

The UK is investing £3m ($4m) to build a workforce capable of delivering cell and gene therapies to patients at commercial scales.

Swedish biologics site a factor in Q1 margin decline, says AZ

25-May-2018 By Flora Southey

AstraZeneca says the build-up of biologics manufacturing capacity at its yet-to-launch facility in Sweden has contributed to a reduced core gross margin this quarter.

US FDA green light for Samsung BioLogics’ mAb production

25-May-2018 By Flora Southey

The US FDA has granted Samsung BioLogics’ second manufacturing plant another approval for monoclonal antibody production.

Parker Bioscience’s UK site to see multi-million dollar investment through 2018

22-May-2018 By Melissa Fassbender

Parker Bioscience’s UK-based site will be expanded as part of a multi-million dollar phased investment program to be completed throughout 2018.

Evolus: US FDA validates troubled CMO site, but rejects BOTOX alternative

22-May-2018 By Flora Southey

Evolus says its South Korean CMO has successfully addressed GMP violations, but US FDA is yet to approve the firm’s alternative to Allergan’s BOTOX.

Agilent anticipates genomics market growth with expansion in Texas

11-May-2018 By Brittany Farb Gruber

Agilent's 15,000-square-foot expansion will increase its capacity to meet a growing demand for next-generation sequencing products from its genomics group.

Novartis wins second US FDA approval for Kymriah, $100k cheaper

08-May-2018 By Flora Southey

Novartis has scored a second US FDA approval for CAR T-cell therapy Kymriah, indicated to treat adult patients with relapsed or refractory (r/r) large B-cell lymphoma.

Catalent plans capacity expansions at two biologics facilities

02-May-2018 By Nick Taylor

Catalent is planning to add capacity at two of its biologics manufacturing facilities, setting it up to grow in an area in which demand continues to outstrip supply.

WuXi Biologics says Ireland an attractive option post-Brexit, invests €325m

02-May-2018 By Flora Southey

The Chinese CDMO says it will build a biomanufacturing facility in Ireland with single-use bioreactors and continuous bioprocessing capabilities.

J&J cutting costs across supply chain to focus resources on 'newer technologies'

01-May-2018 By Melissa Fassbender

Johnson & Johnson has reported plans to cut costs across its supply chain as it looks to shifts focus from “older parts” of its portfolio to newer technologies and capabilities, such as in biologics, says CFO.

Thermo Fisher pumps $50m into biologics manufacturing biz

27-Apr-2018 By Flora Southey

Thermo Fisher Scientific is expanding its biologics manufacturing capabilities in the US for clinical and commercial supply.

Shire turns down Takeda, Allergan toys with buy

20-Apr-2018 By Flora Southey

Shire has rejected Takeda’s acquisition proposals saying the offers ‘undervalue’ its pipeline and potential for growth.

GE launches modular bioprocessing facility for viral vector vaccines

17-Apr-2018 By Flora Southey

GE Healthcare Life Sciences has launched a prefabricated, modular bioprocessing facility designed for the manufacture of viral vector-based therapeutics.

Bio-Separation: Our outgoing editor looks back over 5 years

13-Apr-2018 By Dan Stanton

Biopharma-Reporter editor Dan Stanton is finally packing his buffer bag and moving upstream.

Sanofi: €350m vaccine investment part of ‘digital factory’ ambition

13-Apr-2018 By Dan Stanton

A new vaccine manufacturing facility in Toronto, Canada will boast single-use tech and closed continuous process to help improve productivity and performance, Sanofi says.

GSK offloads gene therapy portfolio and takes stake in Orchard

12-Apr-2018 By Dan Stanton

GlaxoSmithKline has sold a number of gene therapy products – including its approved autologous ex vivo product Strimvelis – to Orchard Therapeutics.

Stellar ups aquaculture on demand for limpet protein used in vaccine production

11-Apr-2018 By Dan Stanton

Demand for a protein produced from a marine mollusk used as a carrier molecule in therapeutic vaccines has driven Stellar Biotech to expand a facility in LA.

Cell therapy demand means CMOs need to up their capabilities, PharmSource

10-Apr-2018 By Dan Stanton

There is a lack of third-party capabilities in the autologous cell therapy space says the new editor of PharmSource ahead of this year’s Interphex Convention.

UPDATE

Plant issues plague Celltrion and Teva as FDA issues two biosimilars CRLs

05-Apr-2018 By Dan Stanton

The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.

Bioprocessing overlap: Taking lessons from small molecule makers

03-Apr-2018 By Dan Stanton

Process control, quality management and training operators are areas where biomanufacturers can learn from small molecule makers, according to preliminary results from a BioPlan Associates survey.

Continuous bioprocessing: A ‘life changing’ method, says NIBRT

30-Mar-2018 By Flora Southey

NIBRT is embracing continuous bioprocessing says training director John Milne, who told us the method helps improve plant flexibility and could reduce manufacturing costs.

News in Brief

Abzena remodels ADC facility in Pennsylvania

28-Mar-2018 By Staff Reporter

Abzena has equipped its $5m Pennsylvania bioconjugation suite with Sartoius and GE Healthcare single-use equipment.

Back to school: Shire trains at NIBRT ahead of biologics site opening

28-Mar-2018 By Flora Southey

Shire is sending its employees to the National Institute for Bioprocessing and Research Training prior to opening its biomanufacturing site in Dunboyne, Ireland.

Hitachi Chemical inks Daiichi Sankyo regenerative meds deal

27-Mar-2018 By Flora Southey

Daiichi Sankyo has selected CDMO Hitachi Chemical Therapeutics Solutions to make regenerative medicine for the Japanese market.

Takeda’s off-the-shelf stem cell therapy approved in Europe

27-Mar-2018 By Dan Stanton

Alofisel (darvadstrocel) has become the first allogeneic stem cell product to be approved in Europe.

WuXi Biologics adds 4,000L bioreactors at fully single-use site

21-Mar-2018 By Dan Stanton

The CMO says adding the single-use offering from ABEC will make the newly opened biomanufacturing site in China comparable to stainless steel for commercial mAb production.

CHO jumping: Samsung BioLogics to develop in-house cell line

20-Mar-2018 By Dan Stanton

Samsung BioLogics will begin offering its own CHO cell line for its customers’ development projects from 2019.

BIOPHARMA AMBITION 2018

Flexible friend: Sanofi talks capacity benefits of Lonza JV

16-Mar-2018 By Flora Southey

Sharing a facility with a CMO gives Sanofi the flexibility to adjust biomanufacturing capacity according to its needs, says its SVP for biologics.

NEWS IN BRIEF

WuXi BioLogics wins Adagene antibody therapeutics contract

13-Mar-2018 By Flora Southey

WuXi BioLogics will develop and manufacture Adagene’s antibody therapeutics for the Chinese market before expanding globally.

AGC Biologics adds 2,000L single-use bioreactor in CA

09-Mar-2018 By Dan Stanton

The biologics CDMO will install a 2,000L single-use bioreactor (SUB) from Thermo Fisher Scientific at its Berkeley facility to meet demand for early-phase projects.

Cryoport ups cold chain presence on regenerative med potential

07-Mar-2018 By Dan Stanton

Cryoport will open two global centres and has inked a deal with McKesson to support the growth in demand for cell and gene therapy logistics.

Emerson gifts automation tech for simulated bioprocessing in Ireland

02-Mar-2018 By Flora Southey

Emerson is donating an automation platform worth $1m to Ireland’s NIBRT for ‘real-life’ industry training in Dublin.

Gene therapy demand drives VGXI to up Texan GMP capabilities

28-Feb-2018 By Dan Stanton

DNA manufacturing and development services VGXI will add two new facilities in response to increased demand for gene therapy products.

Made in Ireland: ABEC adds cleanroom to make large-scale disposable tech

27-Feb-2018 By Flora Southey

ABEC has expanded manufacturing in Ireland with the completion of an ISO-7 cleanroom, where the single-use vendor will make disposable bioreactor bags for global distribution.

Samsung BioLogics wins potential $148m contract at new plant

23-Feb-2018 By Dan Stanton

The manufacturing contract is the first of what Samsung BioLogics expects to be a number of long-term partnerships at its recently completed 180,000L facility.