Analytical (technologies & services)

IQVIA: Healthcare data regional compliance complexity requires AI, ML and NLP automation

29-Jan-2024 By Liza Laws

Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently. Naturally with more and more people using it for work, new regulations on data use and management are starting to appear....

Symbiosis Pharmaceutical Services granted MHRA license following £1 million investment

07-Dec-2023 By Liza Laws

Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a £1 million investment.

Women in Science

Interview: Women in Science - Pamela Adede and her hope for future generations of women to thrive in science

07-Jun-2023 By Liza Laws

Adede is a seasoned computer scientist and data professional known for providing high quality service whilst employing her multi talents which include efficiency, analytical thinking, and fast learning.

Cytiva and Pall Life Sciences complete integration: ‘Uniting gives us the focus, expertise and talent to help our customers discover, develop and deliver the next generations of novel therapeutics’

02-May-2023 By Rachel Arthur

Cytiva and the life sciences business of Pall Corporation are now united as one business under the Cytiva brand, with the completion of the integration announced this morning. Emmanuel Ligner, Danaher Group Executive, President and CEO of Cytiva, tells...

Sterling Pharma Solutions granted MIA license for cGMP antibody-drug conjugate manufacturing at UK facility

20-Apr-2023 By Rachel Arthur

CDMO Sterling Pharma Solutions has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Orgenesis and UC Davis partner on decentralized development and manufacturing of CGTs

20-Mar-2023 By Jane Byrne

Orgenesis is pairing up with University of California, Davis (UC Davis) to deploy cell and gene therapy mobile processing units and labs across California.

Teknova and Sartorius look to address critical pain points in AAV bioprocessing

20-Mar-2023 By Jane Byrne

Alpha Teknova Inc is teaming up with Sartorius BIA Separations, part of the Sartorius life sciences group, to help gene therapy companies streamline the downstream purification process.

Genuv and Celltrion partner on antibody discovery work

16-Mar-2023 By Jane Byrne

South Korean players, Celltrion and Genuv, are teaming up on the discovery and development of therapeutic antibodies using Genuv's mouse platform.

ClinChoice continues expansion with CRO acquisition

07-Mar-2023 By Ben Hargreaves

The company acquires Cromsource, which is a CRO focused on the US and European markets.

PackGene breaks ground on biomanufacturing and process development facility in Houston

28-Feb-2023 By Rachel Arthur

PackGene Biotech, an adeno-associated virus (AAV) vector contract research organization (CRO) and contract development and manufacturing organization (CDMO), is expanding its US services with a new cGMP biomanufacturing and processing facility in Houston....

Donaldson acquires Isolere Bio

21-Feb-2023 By Rachel Arthur

Donaldson Company will acquire Isolere Bio: an early-stage biotech that develops novel and proprietary ‘IsoTag’ reagents and accompanying filtration processes used for the purification and streamlined manufacturing of biopharmaceuticals.

CBM looks to boost viral vector manufacturing capabilities in cell line deal

19-Jan-2023 By Jane Byrne

The unprecedented rise in approvals for new cell and gene therapies, and the increasing industry need for cell lines to support the production of therapeutics, has spurred US CDMO, the Center for Breakthrough Medicines (CBM), to act

UK ATMP clinical research picture remains positive despite challenging global environment

17-Jan-2023 By Jane Byrne

In 2022, the UK continued to have a signficant footprint in ATMP clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022, according to a new report.

EY: Signs biopharma industry ready to return to the big dealmaking table

12-Jan-2023 By Jane Byrne

Last year was a slow one in terms of dealmaking in the life sciences sector but the final quarter saw a major uptick, finds the EY annual M&A Firepower report.

Boost for Axplora’s antibody drug conjugate technology platform

15-Dec-2022 By Jane Byrne

The French National Agency for the Safety of Health Products (ANSM) has granted a pharmaceutical establishment license to Axplora’s Le Mans site.

Licensing deal aimed at progressing cell and gene therapies in the treatment of rare diseases

06-Dec-2022 By Jane Byrne

Curamys, a South Korean biotech developing cell and gene therapy using cell fusion technology to treat rare intractable diseases, has signed a strategic platform licensing agreement with US tech developer, MaxCyte.

Orgenesis secures $50m from Metalmark to develop CGTs at point of care

10-Nov-2022 By Jane Byrne

Orgenesis, the biotech specializing in cell and gene therapy (CGT) at the point of care, and private equity firm, Metalmark, have signed a major investment partnership.

Lonza: N-1 perfusion capability enables increased process titers

04-Nov-2022 By Jane Byrne

The biopharma sector has seen recent advancements in process intensification, especially in relation to upstream processing, with the technology employed aimed at increasing drug output. One of the quickest and simplest ways to achieve process intensification...

Siemens: Digitalization gulf to widen between pharma leaders and laggards over next decade

05-Sep-2022 By Jane Byrne

Digital transformation is fundamental to the growth of the UK and Ireland's biopharma sector, according to a new study by Siemens.

Samsung Biologics on track to open ‘super plant’ in October

28-Jul-2022 By Rachel Arthur

Construction of Samsung Biologics’ Plant 4 is on schedule with operations set to start in October, the company confirmed in its Q2 results this morning.

Ginkgo snaps up synbio rival Zymergen for $300m

25-Jul-2022 By Jane Byrne

Boston based Ginkgo Bioworks is acquiring California headquartered, Zymergen, for $300m, making it the company’s largest acquisition to date.

On-demand cleanrooms help pharma manufacturers ‘fail fast’

13-Jul-2022 By Jenni Spinner

A representative from life-science services company Azzur Group explains how flexibility and speed can help in reaching the best solution more efficiently.

Mission Bio looks to accelerate solid tumor research

12-Jul-2022 By Jane Byrne

San Francisco, California-based Mission Bio is expanding its single-cell DNA toolset.

Fujifilm to invest $1.6bn and make its Hillerød facility in Denmark the largest end-to-end CDMO in Europe

30-Jun-2022 By Jane Byrne

Fujifilm Corporation is to invest US$1.6bn (€1.4bn) to boost the business of its subsidiary, Fujifilm Diosynth Biotechnologies (FDB), a contract development and manufacturing organization (CDMO).

Merck and Agilent to advance process analytical technologies for downstream processing

21-Jun-2022 By Jane Byrne

Merck is collaborating with Agilent Technologies to plug what it calls a critical gap within downstream processing for process analytical technologies (PAT).

‘Networking and relationship building key to finding answers to CGT challenges’

16-Jun-2022 By Jane Byrne

Measuring potency for gene and cell therapies is not so clear-cut, and some companies have hit roadblocks in their submissions to regulatory agencies as a result.

Californian technology company wants to digitize end-to-end supply chains

14-Jun-2022 By Jane Byrne

San Jose, California-based ParkourSC says it has expanded its digital supply chain operations platform to help pharma companies address supply challenges.

Lonza to lend manufacturing expertise and knowledge to Israeli biotechs

24-May-2022 By Jane Byrne

Lonza has entered into a two-year agreement with Israel Biotech Fund (IBF) to support its portfolio of biotech companies.

Novartis looks to work more strategically as CDMO

16-May-2022 By Jane Byrne

Novartis has recently set up a new contract development and manufacturing unit called Global Biotech Co-operations (GBTC).

ExcellGene and Cytena team up to optimize workflows for mAb and therapeutic protein manufacturing

05-May-2022 By Jane Byrne

ExcellGene SA, a Swiss biologics focused CDMO, has established a collaboration agreement with German biological cell instrument developer, Cytena.

Catalent to invest $350m to expand US drug substance and product manufacturing site

22-Apr-2022 By Jane Byrne

Catalent has announced a multi-year $350m investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities.

US and South Korean microbiome CDMO partnership to build US facility

12-Apr-2022 By Jane Byrne

List Bio, together with List Labs, is set to build a new US$125m plant in Indiana, offering end-to-end manufacturing for early-stage development through to commercial production of new microbiome therapeutics.

eTheRNA Manufacturing extends CDMO activities in LNP field

29-Mar-2022 By Jane Byrne

eTheRNA Manufacturing, a specialist RNA process developer and manufacturing member of the eTheRNA group, has introduced a new lipid nanoparticle (LNP) formulation, development and production service.

From textiles to therapies: North Carolina’s journey to a booming biotech hub

29-Mar-2022 By Rachel Arthur

While skills shortages present one of the main challenges to the biopharma industry, North Carolina believes its investments in the life science ecosystem have given it a ‘multiple decade jumpstart’ in building a successful biopharma hub for both manufacturing...

FDA clears ‘rapid’ Terumo BCT collection system as demand for plasma-based therapies grows worldwide

22-Mar-2022 By Jane Byrne

The US Food and Drug Administration (FDA) has cleared a new plasma collection system developed by Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company based in Colorado.

Catalent completes $30m expansion to biologics network

22-Mar-2022 By Ben Hargreaves

Catalent completes expansion of its biologics manufacturing network by upgrading its Limoges, France, location with additional capacity and the ability to produce large molecules.

New insights obtained using cell binding measurements may improve how cell therapies are designed

21-Mar-2022 By Jane Byrne

A study that reveals new understanding of Chimeric Antigen Receptor (CAR) T cell functionality is said to underscore the critical role that cell avidity or binding plays in uncovering and optimizing CAR T cells.

WHO establishes global biomanufacturing training hub in Korea

25-Feb-2022 By Rachel Arthur

A global biomanufacturing training hub will be established in Korea to serve low- and middle-income countries wishing to produce biologicals such as vaccines, insulin, monoclonal antibodies and cancer treatments.

Startup looking to create paradigm shift in cell screening raises $2.89m in seed funding

23-Feb-2022 By Jane Byrne

Semarion Ltd, a University of Cambridge spin-out company combining materials engineering and cell biology to tackle unmet drug screening needs, has just closed a £2.14m (US$2.89m) seed funding round.

Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia to establish mRNA vaccine production

21-Feb-2022 By Jane Byrne

Last week saw the WHO announce the first six countries that will receive the technology needed to produce mRNA vaccines on the African continent, as part of the global mRNA technology transfer hub project.

LNPs as drug delivery platforms: Overcoming bioanalytical hurdles

16-Feb-2022 By Jane Byrne

Lipid nanoparticle systems (LNPs) as a delivery mechanism for novel drug modalities are proving effective, but there are bioanalytical challenges associated with encapsulation, says an expert.

OxDX validating 'deep learning' technology that identifies diseases ‘while you wait’

15-Feb-2022 By Jane Byrne

OxDX has raised £2.6m (US$3.5m) in pre-seed funding to develop AI powered rapid diagnostic technology.

WCG: Consider IBC review requirements early on in HGT clinical trial planning

08-Feb-2022 By Jane Byrne

Planning for Institutional Biosafety Committee (IBC) oversight is a critical and often neglected initiation step for human gene transfer (HGT) clinical research, says an expert.

Mission Bio flags breakthrough: Transfer of first Tapestri clinical trial-ready CGT assay

07-Feb-2022 By Jane Byrne

Mission Bio says it is paving the way for the routine use of its technology in clinical trials on materials to support the next wave of life-saving CGT treatments.

New cell therapy focused CDMO has San Diego blood bank origins

31-Jan-2022 By Jane Byrne

A new California based CDMO has been launched, one that is focused on supporting cell therapy developers.

What changes are needed for more connected and continuous manufacturing?

19-Jan-2022 By Jane Byrne

Biopharma manufacturers continue to evaluate opportunities to improve process performance across downstream unit operations.

Ori Biotech raises over $100m, funds to support launch of CGT manufacturing platform

18-Jan-2022 By Jane Byrne

Ori Biotech Ltd, an innovator in the cell and gene therapy (CGT) manufacturing sphere, has secured over US$100m in an oversubscribed Series B funding round.

Using mice models to gain insight into immune response to SARS-CoV-2

18-Jan-2022 By Jane Byrne

Charles River and La Jolla Institute for Immunology (LJI) are collaborating on a new project to uncover how different cells in the human immune system respond to SARS-CoV-2 in early, acute infection.

Protagen, BioAnalytix, and GeneWerk unveil combined CRO business: ProtaGene

13-Jan-2022 By Jane Byrne

Protagen, BioAnalytix, and GeneWerk this week announced their unified operations and re-brand as ProtaGene, a CRO partner for the biologics and cell and gene therapy developers, from discovery to commercialization.

UK market developments: GHO Capital invests in RoslinCT, Symbiosis expands viral therapy capabilities

11-Jan-2022 By Jane Byrne

Healthcare investors, GHO Capital Partners LLP, have invested in Scotland based, RoslinCT, a contract development and manufacturing organization (CDMO) focused on advanced cell therapies.