Bio-outsourcing

“Money has returned to the market”: Envigo mulls biopharma role in preclinical recovery

29-Sep-2015 By Gareth Macdonald

Demand for biopharmaceutical testing is in part responsible for higher capacity utilisation but, despite encouraging signs, it is too early to say if preclinical pricing will improve accordingly says Envigo.

Lonza's stem cell production insight a boon to innovation and business

28-Sep-2015 By Dan Stanton

Investments in manufacturing and science have left Lonza well placed to cope with skyrocketing demand for stem cell manufacturing, the CMO says.

Lonza paper reveals secrets behind cGMP stem cell production

25-Sep-2015 By Dan Stanton

Lonza has published a guide to clinical-grade induced pluripotent stem cell (IPSC) manufacture, addressing concerns around the derivation of cellular materials.

Cobra and Manchester Uni receive grant for biologics scale-up

24-Sep-2015 By Fiona BARRY

Cobra Biologics, a Swedish contract development and manufacturing organisation, has launched a project to improve scale-up of biologics with the University of Manchester, UK.

Vaccine-maker IDT Biologika launches in US

23-Sep-2015 By Fiona BARRY

German CDMO IDT Biologika has opened its first facility in the US and will contract manufacture vaccines.

Lonza launches extra pluripotent cell lines

21-Sep-2015 By Fiona BARRY

Lonza has expended its stem cell portfolio to offer hMSCs for translational and cell therapy research.

Swedish engineering firm selected to design $76m Russian plasma plant

21-Sep-2015 By Dan Stanton

KeyPlants has been selected for the design and engineering of a 600,000L plasma processing facility operated by Russia’s MasterPlasma.

Bavarian Nordic wins up to $33m to develop J&J Ebola vaccine

16-Sep-2015 By Fiona BARRY

Danish biotech Bavarian Nordic has signed a $9m contract from Johnson & Johnson to improve stability of their joint Ebola vaccine. After options and milestone awards, payment could total $33m.

MedImmune will get first look at biologics ID'd at new UK lab says CRUK

16-Sep-2015 By Gareth Macdonald

MedImmune has first dibs on candidate cancer biologics identified at a lab the AstraZeneca unit set up with Cancer Research UK last week.

Baxalta shifting to biosimilar outsourced model, selling ex-Genmab MN plant

16-Sep-2015 By Dan Stanton

Baxalta will sell a Minnesota facility it acquired from Genmab in 2013 as part of a new outsourcing strategy it has adopted for biosimilar production.

Abzena bolsters biologics business by buying US CDMO PacificGMP

14-Sep-2015 By Dan Stanton

Abzena has broadened its biologics services and added a Californian manufacturing facility through the acquisition of CDMO PacificGMP.

Polpharma hires key member of Sandoz's US Zarxio launch team as biosimilar head

11-Sep-2015 By Gareth Macdonald

Polpharma has hired one of the architects of Sandoz’s recent US Zarxio launch to lead its biologics division.

Aragen Bioscience licenses protein yield boosting tech for cell line development

09-Sep-2015 By Gareth Macdonald

ProteoNic Biotechnology BV has licensed its protein production technology to US contractor Aragen Bioscience.

Horizon to license haploid models to Abcam in deal worth up to $3m

09-Sep-2015 By Fiona BARRY

Horizon Discovery, a UK CRO, will license its cell lines to Abcam for use validating antibodies for up to $3m.

Alexion's Kanuma held back due to US FDA's CMC data demands

08-Sep-2015 By Dan Stanton

Review of Alexion’s enzyme replacement therapy Kanuma (sebelipase alfa) has been pushed back after the US FDA requested more Chemistry, Manufacturing and Controls (CMC) information.

Catalent to continue "disproportionate" focus on biologics through M&A and tech deals

04-Sep-2015 By Dan Stanton

Investments in technologies and capabilities are reaping rewards says Catalent which will continue placing “disproportionate emphasis” on its biologics business.

Boehringer-Ingelheim licenses microbial expression tech for in-house and out

02-Sep-2015 By Dan Stanton

Boehringer Ingelheim has licensed a microbial expression technology from Vectron Biosolutions for use with its own molecules and for customers through its CMO business.

GE gains access to SSB's membrane tech in downstream supply deal

01-Sep-2015 By Dan Stanton

GE Healthcare has extended its purification product portfolio through a supply deal with Sartorius for its membrane adsorber ion-exchange technology.

Many possible suitors for Pfizer’s biosimilar Infliximab, but no clear leader yet

01-Sep-2015 By Dan Rosenberg

Pfizer’s planned divestiture of its infliximab biosimilar candidate could create a race among competitors to gain access to the product, but in the early going, no clear leader has emerged.

Shire to use new suppliers to up production of HAE drug filtered from US plasma

28-Aug-2015 By Gareth Macdonald

Shire will use contractors to increase production of Cinryze, the half billion dollar-a-year Hereditary Angioedema (HAE) drug it bought with ViroPharma in 2014.

Merck KGaA closes Indian bio supplies subsidiary

26-Aug-2015 By Fiona BARRY

Merck Millipore says it has closed the Bangalore plant which produced its GeNei brand of biologics manufacturing and R&D supplies.

UK's Cell Therapy Catapult awarded planning permission for immunotherapy plant

25-Aug-2015 By Dan Stanton

The UK’s Cell Therapy Catapult has received planning permission to build a £55m ($87m) large-scale manufacturing plant.

Hemispherx secures replacement for blood cell supplier BioLife

24-Aug-2015 By Gareth Macdonald

Hemispherx has signed supply deals with US blood centres to address supply issues that delayed relaunch of genital wart drug, Alferon.

$47m innovation facility built in Nottingham, UK

21-Aug-2015 By Fiona BARRY

The UK’s BioCity in Nottingham is adding a £30m ($47m) facility to house life science start-ups including CROs. The site will also become a hunting ground for a soon-to-launch venture capital fund which will invest in the SME tenants.

UK bioindustry group calls for Government biomedical catalyst scheme to continue

21-Aug-2015 By Gareth Macdonald

The UK’s Biomedical Catalyst funding scheme encourages investors to back innovative biopharma research and should be continued according to the BioIndustry Association (BIA).

Hemispherx signs US distribution deals as it preps to relaunch wart drug in US

19-Aug-2015 By Gareth Macdonald

Hemispherx Biopharma has signed extended US distribution agreements as part of efforts to relaunch Alferon N Injection, a genital wart treatment it pulled in 2008 after production costs soared.

Report: UK capacity for cell, gene therapy manufacturing decreases in 2015 as new projects launch

19-Aug-2015 By Zachary Brennan

A surge in UK cell therapy production last year means available manufacturing capacity has declined considerably according to a report by Cell Therapy Catapult.

Pfenex, Emergent win multi-million dollar US government contracts

18-Aug-2015 By Zachary Brennan

Contract manufacturer Emergent BioSolutions and biosimilar developer Pfenex have both announced in recent days that they’ve won contract manufacturing and development grants with the US government.

$17bn Pfizer-Hospira merger approved on anti-trust conditions

05-Aug-2015 By Fiona BARRY

The European Commission has approved Pfizer’s acquisition of Hospira, providing the larger company first divests of its infliximab candidate and several sterile injectables.

TxCell: we’ll continue to use CMO even after we get back our GMP

04-Aug-2015 By Fiona BARRY

French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.

US firm offers CRISPR viral knock-out library for R&D

31-Jul-2015 By Fiona BARRY

Genomics services company Cellecta is offering gene-editing tool CRISPR to researchers wanting to “knock out” human gene functions.

EMD Millipore and celares team to offer PEGylation to biologic makers

29-Jul-2015 By Dan Stanton

Attaching PEG-chains to biological molecules can increase bioavailability and speed up development of protein-based therapies and biosimilars, says EMD Millipore which has inked a deal with PEGylation firm celares.

Roche expanding capacity 40% across network, but will still use CMOs

24-Jul-2015 By Dan Stanton

Roche is expanding its manufacturing operations to service its biologics pipeline, but the firm says it will continue to outsource approximately 20% of all production.

Lonza: global hedge helped offset currency exposure but Visp still a risk

22-Jul-2015 By Gareth Macdonald

Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.

Flexibility replacing capacity in plant design, say engineering firms

22-Jul-2015 By Dan Stanton

Biomanufacturing needs are transitioning and as such there is no set model for facility design, say engineering firms TFS and NNE Pharmaplan.

Stem Cell Theranostics secures "freedom to operate" in IP deal with GE Healthcare

21-Jul-2015 By Gareth Macdonald

Stem Cell Theranostics has secured rights to the technology it uses to make cellular heart disease models for drug development through a deal with GE Healthcare.

Perfusion and chromatography beat ALS cell therapy production challenges, says Goodwin

17-Jul-2015 By Dan Stanton

Goodwin Biotechnology says making trial supplies of Q Therapeutics’ amyotrophic lateral sclerosis (ALS) cell therapy meant overcoming considerable technical hurdles.

CNS drugmaker teams with CDMO on ALS mAb candidate

15-Jul-2015 By Fiona BARRY

CDMO (contract development and manufacturing organisation) Goodwin Biotechnology is working with CNS biotech Q Therapeutics to produce mAbs for a clinical trial to treat motor neuron disease.

Catalent adds antibody combination tech to its biologics arsenal

08-Jul-2015 By Dan Stanton

Catalent has licensed an expression technology from Excelimmune it says could offer biologics makers a cost-effective and simple way to make antibody combination therapies.

Report: Outsourcing becoming more mainstream in biomanufacturing industry

08-Jul-2015 By Zachary Brennan

As biopharmaceutical companies look to cut costs and understand their core competencies further, the use of outsourcing and off-shoring have become even more mainstream than in years past, according to the 12th annual biomanufacturing report from BioPlan...

Sartorius buys Cellca for process dev knowhow

07-Jul-2015 By Gareth Macdonald

Sartorius Stedim Biotech SA (SSB) has acquired cell line and process development contractor Cellca GmbH.

Abivax's IPO to fund HIV and hep B pipeline before potential Big Pharma deal

06-Jul-2015 By Dan Stanton

In France’s largest ever biotech IPO, Abivax has raised €58m ($64m) to continue developing its HIV and Hep B candidates.

Samsung Bioepis mulls NASDAQ IPO to raise cash for biosimilars

01-Jul-2015 By Gareth Macdonald

Samsung Bioepis is considering an IPO on the NASDAQ Stock Exchange to raise cash to fund the development of biosimilar products.

WHO further clarifies ‘biological qualifier’ system for naming biological active substances

01-Jul-2015 By Zachary Brennan

The fight over how to name biosimilars has taken a turn toward further clarification, with the WHO (World Health Organization) offering another, updated draft of its intended policy on "biological qualifiers" (BQ).

US FDA accepts IND for TxCell's Crohn's cell therapy; Firm eyes European CRO for US trial

30-Jun-2015 By Gareth Macdonald

TxCell is set to expand a trial of its candidate Crohn’s disease cell therapy to the US after the FDA accepted its IND application.

TxCell to enhance operator training and sterilisation measures at cell therapy pilot plant

26-Jun-2015 By Gareth Macdonald

TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.

UK’s MHRA helps ‘future-proof’ Fujifilm’s mammalian cell culture manufacturing facility

26-Jun-2015 By Zachary Brennan

In a rare move for the UK’s MHRA (Medicines and Healthcare products Regulatory Agency), the regulator has helped to “future-proof” CMO Fujifilm Diosynth Biotechnologies’ mammalian cell culture manufacturing facility in Billingham, UK against potential...

Scientists create 3D multiple myeloma model to aid preclinical development efforts

22-Jun-2015 By Anthony King

Scientists have developed a new way of visualizing multiple myelomas in 3D by replicating tumours in hens’ eggs in a approach they say will aid drugmakers.

Glowing mice with working immune systems make for better cancer models say scientists

19-Jun-2015 By Anthony King

Mice engineered to recognise light-emitting markers as self will let cancer drug developers to track tumor growth in animals with functioning immune systems say US researchers.