Analytical (technologies & services)

Genezen breaks ground on cGMP lentiviral vector production facility

28-Jun-2021 By Jane Byrne

Genezen Laboratories, Inc, a US cell and gene therapy contract development and manufacturing Organization (CDMO) is set to build a 75,000+ square foot cGMP-compliant lentiviral vector production facility in Indianapolis.

Dispatches from Bio Digital 2021

Thermo Fisher development solution offers timelines of 13 months to clinic

17-Jun-2021 By Ben Hargreaves

Thermo Fisher announces a ‘completely redesigned’ solution to take potential therapies through to early-stage clinical trials.

DIA 2021 Annual Meeting

DIA 2021 set to shed some light on decentralized trials process, accelerated approval pathways

16-Jun-2021 By Jane Byrne

Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.

BIO DIGITAL 2021

BIO Digital lands at a time of ‘unprecedented industry collaboration’

02-Jun-2021 By Jenni Spinner

The online pharma event will address the COVID-19 pandemic’s impact on the industry (and vice versa) and innovation in the face of formidable challenges.

UPS: ‘The market for drugs and therapies requiring cold storage is growing at a rapid rate’

27-May-2021 By Jane Byrne

UPS Healthcare says it has invested in its suite of cold chain technologies on the back of ‘unreal growth’ in the pharmaceutical cold chain market.

Singapore biotech ‘leading the way’ in machine learning and combinatorial genetics secures $43m in funding

26-May-2021 By Jane Byrne

Engine Biosciences, a Singapore- and Silicon Valley-based company with an artificial intelligence-enabled technology platform that is designed to discover new biology targets and disease-causing links amongst known targets, has generated US$43m in a Series...

New Switzerland based hub for pathogen storage, sharing and analysis

26-May-2021 By Jane Byrne

The World Health Organization (WHO) and the Swiss Confederation have launched the first WHO BioHub Facility to enhance the rapid sharing of viruses and other pathogens between laboratories and partners globally.

Gamma Biosiences takes majority stake in Mirus Bio

21-May-2021 By Jane Byrne

Gamma Biosciences has taken a controlling investment in Mirus Bio, an innovator and developer of biomimetic, cell-adaptive lipid-polymer nanocomplexes (LPNCs) for nucleic acid delivery based in Wisconsin in the US.

Thermo Fisher and University of California look to cut costs and speed up adoption of cell therapies

20-May-2021 By Jane Byrne

Thermo Fisher Scientific Inc and the University of California, San Francisco (UCSF) have formed a alliance to accelerate the development and manufacturing of cell-based therapies.

Protalix to propose virtual inspection to clear barrier to FDA approval

20-May-2021 By Nick Taylor

Protalix BioTherapeutics is planning to propose a virtual or record review inspection to clear the barrier to approval of its Chiesi Farmaceutici-partnered Fabry disease treatment.

Can Hootsuite like interface tackle data management challenges in ADC manufacturing?

20-May-2021 By Jane Byrne

Data management in antibody drug conjugate (ADC) manufacturing is challenging says ADC/Labs, which is trying to help scientists in the field get around such obstacles.

Acquisition boosts Charles River's viral vector, AAV and plasmid DNA production expertise

18-May-2021 By Jane Byrne

Charles River Laboratories International Inc is to acquire US based Vigene Biosciences, a cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) providing viral vector-based gene delivery solutions for research and clinical...

Chicago emerging as a life science and biopharma hub

17-May-2021 By Jane Byrne

Many turn to Boston and North Carolina’s Research Triangle to set up life science companies, but Chicago is now also fast becoming a draw in this respect. The city is emerging as a life science and biopharma hub and seems poised for even further growth,...

Novasep expands in France, sees increasing customer demand for ADC manufacturing services

14-May-2021 By Jane Byrne

Novasep has announced a further expansion of its Highly Potent Active Pharmaceutical Ingredients (HPAPIs) manufacturing capabilities at its Le Mans, France site, saying the move strengthens its position as a leading CDMO for the production of innovative...

Continuous manufacturing said to enable faster clinical and commercial pathways

14-May-2021 By Jane Byrne

When it comes to continuous manufacturing, software challenges are greater than the hardware challenges faced in setting up a new manufacturing line, because at this time, due to a lack of standardization, debugging and validation can be significant components...

'Connectivity is a key enabler for continuous manufacturing'

12-May-2021 By Jane Byrne

Connectivity of unit operations is a key enabler for continuous manufacturing to deliver benefits of not only improved mass throughput, but ultimately reduced COGS and increased facility utilization, says Merck.

Charles River: Understanding and mitigating underlying mechanisms behind unwanted toxicities in CAR T cell therapies

11-May-2021 By Jane Byrne

Charles River says the combination of Distributed Bio’s platform, which the CRO recently acquired, with its own downstream characterization capabilities, enables identification of the best lead candidate in CAR T cell therapies – balancing efficacy and...

PPD adds cell and gene therapy testing capabilities to Irish site

10-May-2021 By Jane Byrne

US contract research organization, PPD Inc, is expanding its Athlone, Ireland, GMP laboratory, significantly increasing the size of its current facility and adding cell and gene therapy (CGT) testing to the operation’s portfolio of services.

Rapid detection of COVID-19 and its variants: Nicoya develops innovative saliva test kit

07-May-2021 By Jane Byrne

Ontario-based, Nicoya Lifesciences, is in the process of completing a prototype of a low-cost, single-use device that tests for active SARS-CoV-2 infection, variants and, eventually, other viruses. The novel test is called Atlas.

NPD Gallery: Technology insider

06-May-2021 By Jane Byrne

What's new in the world of biopharma tech? We track the latest in process innovation equipment releases.

Clean Biologics gains foothold in North American market, adds vaccine and biologics focused CDMO to group

05-May-2021 By Jane Byrne

French pharma services provider, Clean Biologics, has acquired Canadian CDMO, Biodextris, in a move it says will boost its analytical and process development, and early-phase clinical manufacturing and quality control testing services for clients in the...

Ori Biotech and ATMPS combine blockchain and CGT technology to streamline production of advanced therapies

03-May-2021 By Jane Byrne

Last month saw ATMPS Ltd, a developer of blockchain-based cell orchestration platforms for advanced therapies, and Ori Biotech, an innovator in cell and gene therapy (CGT) manufacturing platforms, come together in an alliance aimed at creating seamless...

The future of clinical trials: Are DCTs fast becoming the new norm?

28-Apr-2021 By Jane Byrne

As COVID-19 response initiatives and vaccine rollouts begin to bring the pandemic under control, we consider what changes to clinical trials will be made permanent.

Accelerating development of cancer therapies with single-cell multi-omics

02-Nov-2020 By Jane Byrne

Mission Bio has launched a tool it claims will help save the industry billions of dollars in drug development costs and bring life-saving treatments to market at least six months faster.

Oxford Immunotec to supply T cell testing for UK COVID-19 vaccine trials

22-Oct-2020 By Rachel Arthur

Diagnostics company Oxford Immunotec Global PLC has been selected to provide T cell testing to the UK Vaccines Taskforce.

UK biotech in licensing deal with BMS on antibodies screening tool

13-Oct-2020 By Jane Byrne

IONTAS has announced a deal with Bristol Myers Squibb (BMS) in relation to its platform for antibody identification.

How to optimize the pharma supply chain to aid smooth delivery of COVID-19 vaccines

13-Oct-2020 By Jane Byrne

Supply chain security will be vital to ensure effective and safe distribution of vaccines, says a traceability expert.

IONTAS and FairJourney Biologics discover COVID-19 neutralizing antibodies

01-Oct-2020 By Jane Byrne

Two leading clinical research organizations (CROs) say they have identified neutralizing antibodies with great potential for monoclonal antibody treatment.

MaxCyte partners with Apeiron for siRNA immunotherapy

22-Jul-2020 By Ben Hargreaves

MaxCyte and Apeiron enter agreement for the use of engineering equipment for the development of a cell therapy.

Tesla’s ‘side project’ building RNA microfactories for CureVac

03-Jul-2020 By Ben Hargreaves

Elon Musk revealed the news on Twitter that Tesla was working with CureVac and ‘possibly others’ to produce RNA vaccines.

Cytiva launches cryogenic shipment system for cell therapies

03-Jun-2020 By Ben Hargreaves

The company announces a shipping unit for the temperature-controlled delivery of cell therapies and cryopreserved apheresis.

Immunai unveils map of human immune system

18-May-2020 By Jenni Spinner

A research team including MIT, Harvard and Stanford researchers has raised $20m in seed funding for their effort to map out immune cells with machine learning.

How to prevent another COVID-19? ‘Invest in infrastructure’

06-May-2020 By Ben Hargreaves

CEO of Berkeley Lights talks about the company’s work to identify antibodies against COVID-19 and what the long-term picture looks like.

Mogrify and Sangamo in license agreement for ‘off-the-shelf’ CAR-Treg

23-Apr-2020 By Ben Hargreaves

Sangamo plans to utilize Mogrify’s cell conversion technology to develop CAR-Treg cell therapies.

Avectas partners with Vycellix to speed cell therapy production

31-Mar-2020 By Ben Hargreaves

The partners will combine expertise to progress the novel RNA immunomodulator, VY-M.

CGTC in ‘third phase’ expansion of cell and gene manufacturing site

20-Mar-2020 By Ben Hargreaves

CGTC will add seven laboratories to its manufacture site in the UK, with most of the work taking place off-site.

Frontage continues build-out to meet late-stage developers demand

27-Feb-2020 By Vassia Barba

Frontage has announced completion of its Pennsylvania site expansion to boost its offering of bioanalytical services for late-stage cell and gene therapies developers.

WCG continues acquisitive streak with biostatistical consultancy buyout

23-Jan-2020 By Ben Hargreaves

WCG adds to its portfolio of solutions for clinical trial sponsors by acquiring Statistics Collaborative.

Industry equipment is causing a ‘data deficit’, says Fujifilm exec

13-Jan-2020 By Ben Hargreaves

In terms of data generation, equipment currently used in bioprocessing is ‘pretty dumb’ and needs to become more sophisticated, explains Fujifilm CSO.

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.

Continuous bioprocessing is a ‘win-win’ situation

10-Dec-2019 By Ben Hargreaves

The abundance of data made available by continuous bioprocessing allows for more control over the process and can thereby improve the quality of the product, says Pall executive.

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.

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.

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.

BioLife adds cryogenic equipment through acquisition

14-Nov-2019 By Ben Hargreaves

BioLife announces acquisition of Custom Biogenic Solutions, with the company’s latest deal adding liquid nitrogen laboratory freezers and cryogenic equipment to its portfolio.

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.

Germany seen as the leader of European pharma industry

31-Oct-2019 By Ben Hargreaves

Research ranks Germany as the leading nation within Europe due to the high rating of its finished production manufacturing and potential for growth.

‘Creating a learning environment’ necessary to keep up with biopharma evolution

25-Oct-2019 By Ben Hargreaves

The pace of development in the industry sees greater demand for a trained workforce, which is leading away from ‘classroom’ to technology-assisted working environments, says training lead at Zenith.

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.

Top five stories from September

04-Oct-2019 By Ben Hargreaves

The news most interesting to our readers were those featuring collaborations, whether in the production of an Ebola vaccine, biosimilars entering new markets or creating new manufacturing modalities.