Bio-Outsourcing

Catalent takes over Zumutor’s lead candidate manufacture

13-Feb-2020 By Vassia Barba

Under an agreement with Zumutor, Catalent Biologics initiates clinical manufacture of the latter’s lead candidate targeting solid tumors, ahead of FDA filing.

Consolidation continues as Catalent lays down $330m for MaSTherCell

05-Feb-2020 By Ben Hargreaves

Catalent provides another example of the trend by bigger CDMO to snatch up smaller cell and gene therapy specialists.

Bellicum offloads cell therapy plant in switch to outsourced production

28-Jan-2020 By Nick Taylor

Bellicum sells cell therapy manufacturing plant to MD Anderson Cancer Center, strikes master service agreement.

Lonza poised to add 600 staff as investment peak continues into 2020

28-Jan-2020 By Nick Taylor

Lonza set to recruit 600 new staff globally at biopharma unit as spending spree continues.

New CDMO plans $1.1bn cell and gene therapy plant

27-Jan-2020 By Nick Taylor

A newly founded CDMO has outlined plans to invest $1.1bn to become the world’s biggest cell and gene therapy service provider.

Large pharma focusing on in-house biologic manufacture, not outsourcing

24-Jan-2020 By Ben Hargreaves

Capital expenditure is rising across the pharma industry as portfolios and pipelines shift towards biologics, but the largest companies are sticking to in-house production.

Celltrion set to build largest biopharma plant in China

22-Jan-2020 By Ben Hargreaves

The South Korean company plans to invest ₩600bn over a five-year period to support the construction of its first facility in China.

Merck looks to CMOs to help ease vaccine supply bottleneck

20-Jan-2020 By Nick Taylor

Merck enlists CMOs to help increase Gardasil manufacturing capacity in response to rising demand.

Nationwide Children’s Hospital creates for-profit gene therapy CMO

20-Jan-2020 By Nick Taylor

Nationwide Children’s Hospital creates Andelyn Biosciences to provide gene therapy manufacturing services.

Commercial manufacture of Bluebird’s gene therapy begins, launched in Germany

16-Jan-2020 By Ben Hargreaves

Apceth announces that it has started the commercial manufacture of Zyntelgo, after health insurance companies in Germany agree to pricing structure.

Surging local demand drives 24% growth of Korean contract service sector

15-Jan-2020 By Nick Taylor

South Korean contract service market grows 24% as local biopharma companies step up spending.

Yposkesi doubles manufacturing footprint to meet AAVs growing demand

14-Jan-2020 By Vassia Barba

Yposkesi CDMO announces expansion to cover growing demand, strikes a deal on viral vectors production for a gene therapy development project.

Bristol-Myers offloads manufacturing plant to Catalent

13-Jan-2020 By Nick Taylor

Catalent buys Italian manufacturing and packaging plant from Bristol-Myers Squibb, adding oral solid, biologics and sterile product capacity.

WuXi Biologics and Almirall partner to develop dermatological treatments

09-Jan-2020 By Vassia Barba

Almirall enters drug discovery agreement with WuXi Biologics, gaining access to the WuXiBody platform to develop antibodies for the treatment of dermatological diseases.

Adaptate and Iontas partner on antibody selection and optimization

24-Dec-2019 By Vassia Barba

Adaptate gains access to Iontas’ platform to select antibodies with optimal biophysical properties for the development of gamma delta T-cell modulating therapeutics.

3M set to sell biopharma-focused CDMO for $650m

23-Dec-2019 By Nick Taylor

3M agrees to sell drug delivery contract service unit to investment group Altaris Capital Partners.

Bristol-Myers touts CAR-T manufacturing optimization ahead of FDA filing

19-Dec-2019 By Nick Taylor

Bristol-Myers Squibb presents data showing impact of optimization effort on CAR-T production.

CDMO JOINN Biologics raises $60m to build biotech plant

18-Dec-2019 By Nick Taylor

JOINN Biologics raises $60m Series A round to fund construction of Beijing facility.

Janssen to work with Resonant on cancer drug validation

17-Dec-2019 By Vassia Barba

Following a J&J Innovation award, Resonant becomes a partner of Janssen to work on the discovery and validation of antibody therapeutics for cancer.

Samsung execs jailed over alleged fraud at CDMO unit

16-Dec-2019 By Nick Taylor

South Korean court gives jail terms to Samsung executives for alleged destruction of evidence.

Novartis sets 2020 target for commercial readiness of cell therapy CMO

10-Dec-2019 By Nick Taylor

Novartis aims to have its Japanese cell therapy CMO commercially ready in the second half of 2020.

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.

‘High performance’ membrane for in situ cell filtration

10-Dec-2019 By Vassia Barba

Securecell introduces Sephara, an in situ filtration membrane with precise pore size for continuous production of antibodies and exosomes.

Biosana and A*STAR in continuous bioprocessing laboratory project

10-Dec-2019 By Vassia Barba

Biosana to work collaboratively with the Bioprocessing Technology Institute, aiming to design a highly flexible and cost-effective continuous manufacturing solution.

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.

GE Healthcare launches automation software for CAR-T manufacturing

05-Dec-2019 By Vassia Barba

GE Healthcare tops its C-Pro cell processing system with SpinOculation, an automation software that enables closed T cells transduction at the preferred volume and concentration.

NEWS IN BRIEF

CMAB to provide development service for ‘first in class’ Chinese-developed biologic

04-Dec-2019 By Ben Hargreaves

CMAB Biopharma will provide development and manufacturing services for Fapon Biopharma’s potential oncology drug product.

Entera tips contract manufacturing investments to give it an edge

03-Dec-2019 By Nick Taylor

Entera Bio tips investments in manufacturing to give it an edge by driving down the cost of making its products.

‘Insatiable’ demand drives up expectations for Catalent's gene therapy unit

03-Dec-2019 By Nick Taylor

Analyst increases estimate of revenue potential of Catalent’s gene therapy unit in light of ‘insatiable’ demand.

Vaccine priorities drive Altimmune to rethink pipeline

28-Nov-2019 By Nick Taylor

Altimmune cites changing priorities of governments and manufacturers to explain shift in vaccine strategy.

Thermo Fisher expands site, boosts biologics processing offering

28-Nov-2019 By Vassia Barba

Thermo Fisher Scientific doubles the capacity of its gene therapy and viral vector processing facility in Alachua, Florida, to provide scalability to customers.

WuXi Vaccines to build $240m facility in Ireland

27-Nov-2019 By Ben Hargreaves

WuXi Biologics furthers its manufacturing presence in Ireland with a manufacturing facility for its vaccines subsidiary, which will be able to produce both drug substance and drug product.

GE Healthcare pairs up with Pharmadule to expand KUBio offering

27-Nov-2019 By Vassia Barba

GE Healthcare assigns Pharmadule Morimatsu to expand the offering of its ‘factory in a box’, known as KUBio, enabling the scale-up of biologics manufacture.

GHO raises €975M for more European contract service buyouts

26-Nov-2019 By Nick Taylor

GHO Capital Partners raises €975m European healthcare fund to place another set of bets on contract service providers.

Ascendis builds up secondary supplier to support global TransCon expansion

26-Nov-2019 By Nick Taylor

Ascendis builds up secondary supplier to secure manufacturing capacity for planned global rollout of TransCon growth hormone.

Cell and gene therapy boom creates CDMO capacity bottleneck

25-Nov-2019 By Nick Taylor

The rapid expansion of the cell and gene therapy pipeline creates constraints on access to contract capacity.

Pharma Integrates

Industry’s shift towards large molecules and how to maintain balance

21-Nov-2019 By Vassia Barba

Executives from the largest companies in the industry discuss the increasing prevalence of biologics and the future focus for therapeutics at Pharma Integrates.

Teva spinout eyes outsourced manufacturing scale up after $85M IPO

21-Nov-2019 By Nick Taylor

89bio plans to invest up to $10m (€9m) in manufacturing and scale up, after raising $85m in an upsized IPO.

Fujifilm expands gene therapy analytical services with $55m lab

21-Nov-2019 By Vassia Barba

Fujifilm Diosynth opens a 60,000-square-feet Gene Therapy Innovation Center to support upstream, downstream and analytical development services.

Editas touts manufacturing benefits of teaming up with AskBio

20-Nov-2019 By Nick Taylor

Editas Medicine points to AskBio’s ‘excellent manufacturing facility’ and associated expertise to explain benefits of recent partnership.

Akeso speeds up antibody production in China with GE’s platform

19-Nov-2019 By Vassia Barba

GE to set up its FlexFactory platform for antibody manufacturing at Akeso’s facility in Guangzhou, aiming to optimize the latter’s biologics production.

CPhI Worldwide 2019

Early monitoring key to countering variability in bioproduction

14-Nov-2019 By Vassia Barba

Regardless of the quality of the raw materials used in bioproduction processes, variability is a very common threat that can be addressed, says Thermo Fisher executive.

Dupixent drives up Regeneron spending on contract manufacturing

14-Nov-2019 By Nick Taylor

Regeneron Pharmaceuticals increases spending on collaboration and contract manufacturing by 39% on rising Dupixent sales.

Mesa Labs in $180m Gyros acquisition for biopharma asset development

12-Nov-2019 By Ben Hargreaves

Mesa Labs buys Gyros to gain access to the latter’s capabilities in the discovery, development and manufacture of biotherapeutics.

Samsung takes on clinical manufacturing of Ichnos’ mAb candidate

06-Nov-2019 By Vassia Barba

Samsung continues an agreement formerly signed with Glenmark to manufacture Ichnos’ mAb treatment candidate for atopic dermatitis, as the product enters Phase III clinical trials.

Astellas taps into Pandion’s platform for bispecifics development

05-Nov-2019 By Vassia Barba

Astellas and Pandion join forces to develop treatments for autoimmune pancreatic diseases using the latter’s modular immune effector.

Automating cell and gene therapy manufacture ‘has to be accelerated’, says Lonza CEO

04-Nov-2019 By Ben Hargreaves

Marc Funk explains how the company is ensuring it has the right people in place to move advanced therapies forward and into the future of manufacture.

Merck forced to borrow half of CDC stockpiles of Gardasil to meet demand

30-Oct-2019 By Ben Hargreaves

Merck announces that it has reallocated Gardasil from the US CDC stockpiles, as a surge in demand sees revenues from the vaccine rise 26% year-on-year.

GE Healthcare sets up UK biotech R&D lab

24-Oct-2019 By Vassia Barba

GE Healthcare opens lab space to provide developers with access to protein and cell analysis technologies to encourage networking and partnering on R&D services.