Bio-Outsourcing

update

WHO praises China vaccine rules and flags country as future supply hub

16-Jul-2014 By Gareth Macdonald

Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.

UK to set up personalised meds focused manufacturing tech test centre

11-Jul-2014 By Gareth Macdonald

A new UK “biologics facility of the future” (FoF) testing centre will let biopharma tech firms develop smaller-scale manufacturing systems for personalised medicine production according to the Centre for Process Innovation (CPI).

Bio-techne boosts antibody portfolio with $60m Novus acq

09-Jul-2014

Protein manufacturer Bio-Techne has expanded its purified proteins portfolio through the $60m (€44m) acquisition of antibody developer Novus Biologicals.

Sanofi Pasteur licenses temperature-stable mRNA vaccine from CureVac

08-Jul-2014 By Fiona Barry

Sanofi Pasteur, the vaccines division of Sanofi, has signed an agreement with German biopharma firm CureVac to develop a Messenger RNA-based vaccine.

Novartis licenses ProBioGen’s ADCC enhancement tech

08-Jul-2014 By Zachary Brennan

Novartis has agreed to a non-exclusive licensing agreement with German-based ProBioGen to use its GlymaxX Antibody Glyco-Engineering technology.

‘Why do we put that in?’ SAFC analyses cell culture media

02-Jul-2014 By Fiona Barry

A programme by SAFC is characterising raw materials to reduce delays and cell death in biologics manufacturing, its head of R&D tells BioPharma-Reporter.com.

Synthon contracts Antitope for ADC testing

02-Jul-2014

Synthon has called on UK immunogenicity testing firm Antitope to analyze its pipeline of antibody drug conjugate (ADC) candidates.

BioOutsource targets biosimilars testing growth with new US lab

01-Jul-2014 By Gareth Macdonald

US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.

Rentschler expands manufacturing capacity again, this time with stainless steel

01-Jul-2014 By Zachary Brennan

The Laupheim, Germany-based CMO (contract manufacturing organization) Rentschler Biotechnologie has invested €24m ($33m) to build a twin stainless steel bioreactor system.

Cook Pharmica teams with cell line development firm Selexis

27-Jun-2014 By Gareth Macdonald

Cook Pharmica and Selexis claim their combined service offering will help biopharmas scale up mAb and biosimilars production faster and more cheaply.

Lonza says stem cell reprogramming makes for better preclinical models

25-Jun-2014 By Gareth Macdonald

Lonza has launched a new stem cell reprogramming and maintenance system that has already been used to support US NIH and pharmaceutical company preclinical drug development projects.

SAFC to make virus-resistant cell lines

24-Jun-2014 By Fiona Barry

BioReliance and its parent company SAFC say they are working on viral-resistant cell lines that will prevent contamination in bioreactors.

Dispatches from DIA

Global biosimilar regulations diverging, experts say

20-Jun-2014 By Zachary Brennan

As biopharma companies look to take advantage of a biosimilar market set to exceed $3.7bn by 2016, experts say the different regulations governing the follow-on biologics may be an issue as the markets become more developed.

Biosimilars may not deliver cost savings once expected, study finds

13-Jun-2014 By Zachary Brennan

Biosimilars will not deliver the same cost savings as generic drugs and may not even gain a strong foothold in the biologics market until 2019, according to a new report from GlobalData.

ADC pipelines drive single-use expansion at Lonza's clinical facility

11-Jun-2014 By Dan Stanton

Lonza has invested in single-use technology at its Swiss clinical manufacturing facility citing a rise in demand as customer’s grow their antibody-drug conjugate (ADC) pipelines.

Pfizer, Merck and J&J discuss differing biosimilar strategies

06-Jun-2014 By Dan Stanton

Big biopharma biosimilar development strategies vary substantially with Pfizer, Merck and Janssen split on how best to approach the burgeoning market.

PacificGMP doubles production capacity with GE bioreactor

06-Jun-2014 By Zachary Brennan

CDMO (contract development and manufacturing organization) PacificGMP has doubled its GMP (good manufacturing practice) production capacity with the addition of a second System 1000 bioreactor platform from GE Healthcare.

Janssen in $365m licensing deal to develop prostate cancer drugs

04-Jun-2014 By Dan Stanton

Janssen has licensed the LADD immunotherapy platform and GVAX cell-line technology from Aduro BioTech in order to develop combination therapies for a number of prostate cancer candidates.

Another Soliris recall as Alexion evaluates its manufacturing network

03-Jun-2014 By Dan Stanton

Alexion has recalled another nine lots of Soliris after finding "visible particles" in vials of the $600,000-a-year drug for the third time in 10 months.

Oncobiologics-Ipca JV will replicate US biosimilars plant in India

03-Jun-2014 By Dan Stanton

Oncobiologics will replicate its US biomanufacturing facility in India as part of a new biosimilars-focussed deal penned with drugmaker Ipca.

BioAtla hails CAB patent to increase antibody potency

30-May-2014 By Anthony King

BioAtla has received a broad patent covering conditionally active biologics (CABs) and says this antibody platform could shake up the development of this new class of therapeutics.

SAFC expands continuous flow capacity in Wisconsin

30-May-2014 By Zachary Brennan

SAFC, the custom manufacturing services business of Sigma-Aldrich, has installed a new commercial-scale continuous flow reactor at its Sheboygan, Wisconsin, facility with capacity to produce up to 150 kg of product per day.

Inside NIBRT: Ireland’s 'flight simulator for biopharma manufacturing'

27-May-2014 By Dan Stanton

A government funded bioprocessing institute is helping to drive biopharma investment and retrain workers in Ireland, and Biopharma-Reporter.com visited to find out what happens in this "flight simulator for biopharma manufacturing."

Hemispherx signs with GP Pharm to manufacture Ampligen in Argentina

23-May-2014 By Zachary Brennan

Hemispherx Biopharma announced a preliminary stage agreement with GP Pharm to manufacture Ampligen in Argentina in order to serve Latin American markets pending approval.

Horizon says cell service purchase will drive upstream and downstream

21-May-2014 By Fiona BARRY

Horizon, which supplies genomics research services, has bought cell-screening business CombinatoRx from Zalicus for £4.74m ($8m) and plans more acquisitions.

Scientists look to deliver gene therapy via polymer nanoparticles

20-May-2014 By Anthony King

Scientists in the US report that gene therapy could be delivered using plastic biodegradable nanoparticles

Survey finds solid base for early phase cell therapy manufacturing in UK

20-May-2014 By Zachary Brennan

The UK manufacturing sector covers all of its bases in terms of the current cell therapy manufacturing requirements and includes “a strong manufacturing base” to bring early phase academic research into the clinic, according to a survey conducted by Cell...

Cytovance to scale up mAb for Selexys’s Phase I trial

16-May-2014 By Fiona BARRY

Cytovance will use both single-use and stainless steel in its monoclonal antibody (mAb) manufacturing deal with Selexys Pharmaceuticals.

CMC to manufacture cancer mAb for MacroGenics

14-May-2014 By Fiona BARRY

CMC Biologics, a contract manufacturing organization (CMO), has been picked by biopharmaceutical company MacroGenics to make its oncology candidate as "an extension of their own technical team."

Texas biomanufacturing centre aims to up US medical countermeasures

09-May-2014 By Zachary Brennan

Armed with a $285m investment from the US Department of Health and Human Services – the largest of three investments -- the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM) is now using advanced manufacturing techniques...

UCB aims to halve antibody discovery time with robot

09-May-2014 By Fiona BARRY

UCB has launched a robot it says can halve antibody discovery time.

'Milestone for Chinese Biologics' as WuXi wins mAb contract

07-May-2014 By Dan Stanton

In what it says “is a milestone for the Chinese Biologics industry,” WuXi PharmaTech beat off bids from Lonza and Boehringer Ingelheim to make a monoclonal antibody for TaiMed

Gallus enters cell line optimization, manufacturing agreement with Omni Bio

06-May-2014

CMO Gallus BioPharmaceuticals and Omni Bio Pharmaceutical jointly announced finalization of a multi-stage manufacturing services agreement.

US FDA stings scorpion anti-venom biomanufacturer with Warning Letter

02-May-2014 By Dan Stanton

No shortage of an FDA approved scorpion anti-venom biopharmaceutical is envisioned after a manufacturing facility in Mexico received a Warning Letter, US distributor Rare Disease Therapeutics says.

Waters sees chromatography growth despite flat Q1

30-Apr-2014 By Dan Stanton

Bioprocessing instrument manufacturer Waters has reported a flat Q1, but management predicts new products and a delayed release of capital from large pharma will lead to growth in 2014.

Biopharma turns to outsourcing for more common, simple tasks, survey finds

29-Apr-2014 By Zachary Brennan

Biopharma is ramping up the outsourcing of some of the easier tests while tasks such as downstream process development and QbD services are being outsourced less, according to a new survey.

Lonza: growth in mammalian services as ADC plant opening nears

29-Apr-2014 By Dan Stanton

Increased demand for mammalian technologies will boost Lonza further when a new Swiss facility comes online offering “unique” complete development and manufacturing ADC services, the firm says.

SAFC Q1: ‘weak’ manufacturing, but investments to come

25-Apr-2014

SAFC (Sigma-Aldrich Corporation) says it will invest across its life science businesses following a first quarter that saw “weak” contract manufacturing but flourishing viral and cell media sectors.

B-MS, Samsung extend biologics manufacturing agreement

25-Apr-2014 By Zachary Brennan

Bristol-Myers Squibb and Samsung Biologics have expanded their existing agreement in which Samsung will manufacture several unnamed biologics at its Incheon, South Korea manufacturing site. Financial terms of the agreement were not disclosed.

MacroGenics extends license of Polytherics' Thiobridge ADC tech

11-Apr-2014 By Dan Stanton

Recent investments in antibody-drug conjugate (ADC) technology will translate into more products on the market, but it will take time says Polytherics who has extended its licensing deal with MacroGenics.

Integrity test helps assure no flaws in single-use systems, says ASI

09-Apr-2014 By Dan Stanton

ASI has developed a last-chance confidence test for single-use biomanufacturers looking for assurance there are no flaws in their bioreactor bags.

Takeda licenses Fleximar-ADC conjugation and linker tech from Mersana

09-Apr-2014 By Dan Stanton

Takeda has licensed a biodegradable polymer and customisable linker platform from Mersana Therapeutics who says the tech offers advantages over other antibody-drug conjugate (ADC) approaches.

Cobra's French mAb customers to get R&D tax credit

01-Apr-2014 By Gareth Macdonald

French mAb developers that hire Cobra Biologics stand to benefit from tax breaks after the French Ministry of Higher Education and Research (MESR) named the CMO as a preferred provider.

Cytovance extends mAb manufacturing agreement with Precision Biologics

28-Mar-2014 By Zachary Brennan

CMO Cytovance Biologics is extending its manufacturing agreement with Precision Biologics to advance clinical trials with its leading monoclonal antibody candidate, which is being developed as a therapeutic candidate for pancreatic and colorectal cancers....

Aspyrian and Goodwin team to 'shed light' on ADC candidate

26-Mar-2014 By Dan Stanton

Aspyrian Therapeutics has teamed up with Goodwin Biotech to make antibody-drug conjugates (ADCs) with a technology platform that uses near‐infrared (NIR) light to activate the cytotoxin.

UPDATE

Indiana biosimilar switching requirements become law

26-Mar-2014 By Gareth Macdonald

Industry group BIO has commended Indiana Governor Mike Pence for signing laws that will mean doctors must give pharmacists permission to switch a biologic for a biosimilar.

Covance to bring more biologics bioanalysis capacity online in 2014

25-Mar-2014

Covance has announced that its recently expanded large molecule bioanalytical space at its laboratory facility in Indianapolis will come online in late 2014.

News from Interphex 2014

Catalent commits to ADCs by upping its stake in Redwood

25-Mar-2014 By Dan Stanton

Catalent has increased its stake in Redwood Biosciences telling us it is committed to the development of antibody-drug conjugates (ADCs) and the SMARTag technology platform.