Facilities

Thermo Fisher ups clinical, commercial capabilities with $50m investment

25-Apr-2019 By Melissa Fassbender

Thermo Fisher Scientific is investing $50m to further expand its biologic drug substance capabilities for both clinical and commercial supply.

GeneDesign opens large-scale production facility in Osaka

23-Apr-2019 By Vassia Barba

The Ajinomoto subsidiary opens a development and production base for oligonucleotide drug substances in Japan.

Alvotech provides Stelara biosimilar supply to Fuji Pharma

17-Apr-2019 By Ben Hargreaves

Fuji Pharma signs agreement to receive an exclusive supply of the ustekinumab biosimilar for the Japanese market, furthering a previous investment agreement.

Catalent’s $1.2bn Paragon deal sign of booming gene therapy market

16-Apr-2019 By Ben Hargreaves & Vassia Barba

Catalent to acquire Paragon and plans “substantial capital investments” to ensure Paragon’s further growth, the latest deal in a busy area.

BIO-Europe Spring

Chinese biotechs not ‘inferior’ but actually ‘leapfrogging’ European counterparts

05-Apr-2019 By Ben Hargreaves

The pace at which the Chinese biotech ecosystem is growing has been missed by Europeans, suggests one executive at BIO-Europe Spring.

Alcami Biologics to meet biopharmaceutical demand

03-Apr-2019 By Maggie Lynch

Alcami debuts Alcami Biologics to provide analytical testing, manufacturing, and packaging to the biopharmaceutical industry.

Novo Nordisk initiates $100m rebuild of facilities for next-gen products

02-Apr-2019 By Ben Hargreaves

The Danish company is investing in the rebuild of its existing facilities and is adding production equipment at its site in Kalundborg.

Yescarta to Europe: Steps learned and production 97% on-spec

01-Apr-2019 By Ben Hargreaves

The difficulties in the manufacture of CAR-T treatments have become increasingly understood as the breakthrough technology has been commercialised, but Kite’s head of medical affairs says its process is nearly flawless.

GE Healthcare and Rockwell work towards biopharma 4.0

29-Mar-2019 By Ben Hargreaves

GE Healthcare partners with Rockwell to improve bioprocessing automation operations, which could reduce review time of batch files and processes by weeks.

MaSTherCell brings ‘large-scale’ advanced therapeutics manufacturing to Europe

28-Mar-2019 By Ben Hargreaves

The CDMO leases a facility in Belgium to manufacture cell and gene therapies at a large-scale, in a move the company claims is a first in Europe.

Investment in UK biotech is up 40% in 2019

27-Mar-2019 By Ben Hargreaves

Investment in UK biotech has climbed dramatically year-on-year in the early part of 2019, according to a BIA report.

Pall agrees to develop New Jersey cell and gene therapy sites

26-Mar-2019 By Ben Hargreaves

Pall Biotech signs an industry participation agreement with the New Jersey Innovation Institute to create two centres designed to develop and manufacture cell and gene therapies.

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.

Takeda’s plasma manufacturing facility approved by FDA

20-Mar-2019 By Maggie Lynch

US FDA approves Takeda’s acquired plasma manufacturing facility in Georgia, US, for the production of flexbumin 25% solution.

Cellectis to build CAR-T manufacturing sites in US and Europe

14-Mar-2019 By Ben Hargreaves

In a step towards the commercialisation of its ‘off-the-shelf’ CAR-T therapies, Cellectis begins construction of a facility in France and enters lease agreement for US facility.

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.

NEWS IN BRIEF

Sagent acquires US facility with an eye on future biosimilar products

12-Mar-2019 By Staff reporter

Sagent purchases Xellia’s FDA-approved site in North Carolina, which has capabilities to manufacture both small molecule and biologic products.

Fujifilm continues ‘aggressive’ expansion with $890m site purchase

12-Mar-2019 By Ben Hargreaves

Fujifilm continues investment in its manufacturing capabilities through the acquisition of a large-scale biologics site from Biogen.

‘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 Healthcare working ‘two to three years’ ahead anticipating manufacturing advances

06-Mar-2019 By Ben Hargreaves

The rapid evolution of cell and gene therapy technology is leading GE Healthcare to explore partnerships to meet increasing manufacturing demand, according to the company's enterprise solutions leader.

Cell therapy market to triple in size by 2025

04-Mar-2019 By Ben Hargreaves

The market for cell therapy products is set to expand based on increasing investment from the industry and the implementation of advanced manufacturing technologies.

Allogene builds allogeneic CAR-T site, looking ahead to ‘commercial product’

27-Feb-2019 By Ben Hargreaves

Allogene enters a lease agreement to develop a 118,000-square-foot site for the manufacture of allogeneic CAR-T therapies.

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.

How to solve a problem like Kymriah

22-Feb-2019 By Ben Hargreaves

In its full-year financials, Novartis announced plans to transform its cell therapy manufacturing process through greater investment and utilisation of digital technologies.

WuXi Biologics expects to receive EU GMP nod in matter of months

21-Feb-2019 By Ben Hargreaves

The EMA completes pre-approval inspection of WuXi Biologics facilities, raising no critical issues for the Chinese company.

Novartis doubles investment in AveXis North Carolina site

20-Feb-2019 By Ben Hargreaves

In addition to the $55m previously invested, Novartis will spend a further $60m in expanding AveXis’ site in North Carolina enabling the manufacture of multiple gene therapies simultaneously.

European manufacturing waiver to ‘level the playing field’

18-Feb-2019 By Ben Hargreaves

The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.

FDA observes manipulation of data at Immunomedics facility

14-Feb-2019 By Ben Hargreaves

Following the US FDA issuing a CRL to Immunomedics, the agency has revealed its inspection found instances of data integrity breaches and manipulation.

Bringing gene therapy manufacture in-house avoids ‘imbalanced’ CMO relationship

28-Jan-2019 By Ben Hargreaves

The explosion of the gene therapy industry is leading to supply issues, which has led one company to view producing its own clinical materials as its best option.

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.

GE Healthcare and G-CON create platform for advanced therapy production

24-Jan-2019 By Ben Hargreaves

GE Healthcare and G-CON have combined capabilities to offer drug developers ‘readily deployable’ manufacturing platforms for cell therapies and viral vectors.

Immunomedics receives FDA complete response letter

24-Jan-2019 By Maggie Lynch

Immunomedics received a complete response letter from the US FDA for its BLA seeking approval of its biologic, sacituzumab govitecan.

Boehringer expands commercial biologics production capacity in China

22-Jan-2019 By Ben Hargreaves

Boehringer will increase its capacity for commercial manufacturing of biologics at its Shanghai, China, facility.

UPDATE

Industry in conflict over generic and biosimilar manufacturing waiver

22-Jan-2019 By Ben Hargreaves

European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.

AZ to close two facilities in Colorado

15-Jan-2019 By Ben Hargreaves

The UK company will close two facilities in Boulder and Longmont eliminating 210 positions.

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.

Fujifilm invests $112m on two fronts with new site and expansion

08-Jan-2019 By Ben Hargreaves

Fujifilm has launched an upgrade to its subsidiaries manufacturing capabilities, by increasing capacity by 50% at an existing facility and building an entirely new site for cell technology.

Novartis makes acquisition to buildout CAR-T capabilities

02-Jan-2019 By Ben Hargreaves

Novartis will acquire French CDMO, CellforCure, to expand its cell and gene therapy manufacturing network.

Biologics CDMO buys Shire Massachusetts facility

02-Jan-2019 By Staff Reporter

Rentschler Biopharma will buy Shire’s development and manufacturing facility in Milton, Massachusetts, where the latter makes haemophilia A product, Obizur, for commercial production.