Bio-outsourcing

ProBioGen to make ADCC-enhanced cancer stem cell mAb for Chiome

24-Oct-2017 By Flora Southey

Chiome Bioscience has selected ProBioGen to develop and manufacture its monoclonal antibody LIV-1205, which is designed to combat liver cancer and solid tumours.

Batavia adding 50 jobs in US viral vector and EU cleanroom expansion

17-Oct-2017 By Dan Stanton

Batavia Biosciences will expand a Dutch production facility and build a viral vector plant in the US to cater for demand for its bioprocessing services.

Selexis says KBI collaboration offers ‘gene to GMP’ in 10 months

13-Oct-2017 By Dan Stanton

Pelican Therapeutics has teamed with Selexis and sister CMO KBI Biopharma to advance two monoclonal antibody candidates.

US FDA approves production at Samsung Biologics 152,000L plant

12-Oct-2017 By Dan Stanton

The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.

News in Brief

MilliporeSigma opens $115m life science centre in Massachusetts

11-Oct-2017 By Staff Reporter

MilliporeSigma has cut the ribbon on a life science site in Burlington that incorporates a biomanufacturing equipment education centre.

Cut price Kymriah? ThermoGenesis thinks so with automated CAR-T tech

10-Oct-2017 By Dan Stanton

ThermoGenesis says it can reduce the cost of making CAR-T cell therapies five-fold through its recently acquired automated tech platform.

Arecor licenses out formulation tech to biosimilar developer

10-Oct-2017 By Dan Stanton

Arecor says its protein and peptide formulation technology can provide a competitive advantage for biosimilar developers as it announces its first licensing deal.

IPS & G-CON launch prefabricated cleanrooms biz

06-Oct-2017 By Flora Southey

Integrated Project Services (IPS) and G-CON Manufacturing are collaborating to supply prefabricated cleanrooms for biomanufacturing, known as PODs.

The tech behind the first FDA-approved CAR-T cell therapy

03-Oct-2017 By Melissa Fassbender

To develop the first-FDA approved CAR-T immunotherapy, Novartis used Thermo Fisher’s proprietary cell therapy systems (CTS) Dynabeads technology.

Exclusive interview from Biotech Week Boston

Balancing the up and downstream: Repligen CEO talks R&D and M&A

03-Oct-2017 By Dan Stanton

Repligen’s customer GE Healthcare opted to make its latest Protein A ligand in-house, but CEO Tony Hunt remains confident in his firm’s long-term partnerships and diversified bioprocessing offering.

PETA protests against Charles River at Biotech Week Boston

28-Sep-2017 By Dan Stanton

Campaigning group People for the Ethical Treatment of Animals (PETA) picketed a conference in Boston on Tuesday to protest the use of animals in drug research and development.

Biotech Week Boston

Brammer leans on Pall for $50m cell & gene therapy plant expansions

27-Sep-2017 By Dan Stanton

The contract development and manufacturing organisation (CDMO) has selected Pall Life Sciences as its single-use equipment partner at its sites in Florida and Massachusetts.

ADC Biotechnology secures $11m for commercial biomanufacturing plant

26-Sep-2017 By Gareth Macdonald

ADC Biotechnology has announced it will spend $11m ($9.2m) build a bio-conjugation facility at a site in Deeside, North Wales.

Biotech Week Boston

Protein A's mAb capture efficacy offsets cost, says GE launching new offering

26-Sep-2017 By Dan Stanton

GE Healthcare has launched a Protein A resin it says can improve monoclonal antibody purification capacity by up to 40% compared to its current offering.

Robust logistics system key challenge for cell therapies, Kiadis

22-Sep-2017 By Dan Stanton

Kiadis Pharma says it is looking at expanding production of its blood cancer cell therapy candidate ATIR101 after receiving US FDA breakthrough designation.

Catalent to buy Cook Pharmica for $950m in cash

19-Sep-2017 By Gareth Macdonald

Catalent Inc has announced it will buy Cook Pharmica for $950m (€792m) in cash to boost its high tech drug production business.

Samsung Bioepis will use CMOs to make Ontruzant if it is approved

19-Sep-2017 By Gareth Macdonald

Samsung Bioepis will use contractors to make its candidate Herceptin biosimilar Ontruzant if it goes on to be approved in Europe.

Bayer takes a shine to Berkeley Light's Beacon biologics workflow tech

19-Sep-2017 By Dan Stanton

Bayer has signed a deal to use Berkeley Lights’ automated biological workflow platform for cell line development and antibody discovery.

Synpromics expansion to support growing gene control business

19-Sep-2017 By Dan Stanton

Moving to a larger facility will help Scottish firm Synpromics Ltd increase its gene control and cell line services presence, the firm says.

US FDA approves Amgen and Allergan's Avastin biosimilar

15-Sep-2017 By Gareth Macdonald

US regulators have approved Amgen Inc’s Mvasi (bevacizumab-awwb), a biosimilar version of Roche’s monoclonal antibody (mAb) cancer treatment Avastin (bevacizumab). 

Kaneka Eurogentec to build biodrug production plant in Belgium

14-Sep-2017 By Gareth Macdonald

Kaneka Eurogentec has announced plans to build a biopharmaceutical manufacturing facility in Seraing, Belgium.

Momenta: WuXi single-use capacity expansion to support changing biosimilar demand

14-Sep-2017 By Dan Stanton

Momenta says flexibility built into its contract with WuXi Biologics will offset fluctuations in demand for global biosimilars.

Fujifilm Diosynth Biotechnologies opens new UK lab

13-Sep-2017 By Gareth Macdonald

Fujifilm Diosynth Biotechnologies has opened a $9m process development laboratory in Teeside, UK.

Expression yourself: Win an iPad in our bioprocessing survey

12-Sep-2017 By Dan Stanton

Is plastic fantastic? Is stainless still à la mode*? Do Chinese hamsters continue to tow the cell line? Biopharma-Reporter wants your opinions for its second annual biomanufacturing survey.

CGT Catapult teams with TrakCel for cell and gene therapy tracking

08-Sep-2017 By Gareth Macdonald

Firms that make therapies at the Cell and Gene Therapy Catapult facility in Stevenage, UK will track their products using tech provided by TrakCel.

GE launches cell therapy thawing tech

06-Sep-2017 By Dan Stanton

GE Healthcare has launched a thawing technology for cell therapies it says removes the risks and inconsistencies of standard water baths.

Portola hires Lonza for AndexXa supply under Swiss CMO's Ibex service

06-Sep-2017 By Gareth Macdonald

Portola Pharmaceuticals Inc has hired Lonza to make AndexXa (andexanet alfa), the candidate anticoagulation antidote it resubmitted for US FDA review last month.

China’s 3SBio enters North American market through $290m Therapure buy

05-Sep-2017 By Dan Stanton

3SBio will leverage Therapure’s downstream purification expertise to bolster its own biologics portfolio while expanding its contract biomanufacturing business and global presence.

US FDA tells Cellectis to halt cell therapy trials after patient death

05-Sep-2017 By Gareth Macdonald

The US FDA has ordered Cellectis SA to halt studies of its cell therapy UCART123 after the death of a patient.

Dude where’s my CAR-T? Personalised meds need personalised logistics, says TrakCel

01-Sep-2017 By Dan Stanton

After receiving approval Kymriah, Novartis must prove it can handle the supply chain complexities of manufacturing high-value and time-sensitive CAR-T cell therapies, says logistics firm TrakCel.

CAR-T before the bourse: Kymriah OK will ease fundraising but price an issue says ISCT

01-Sep-2017 By Gareth Macdonald

US approval for Novartis’s CAR-T cancer treatment Kymriah will help cell and gene therapy firms attract the investors they need to fund development according to International Society for Cellular Therapy (ISCT).

Oxford BioMedica could pocket $100m on Novartis CAR-T cell success

31-Aug-2017 By Dan Stanton

Oxford BioMedica saw its share price jump 21% after the US FDA approved Kymriah, the gene modified cell therapy made with the firm’s lentiviral vectors.

From vendor to tender: Thermo Fisher completes $7.2bn Patheon acquisition

30-Aug-2017 By Dan Stanton

Thermo Fisher has entered the contract development and manufacturing (CDMO) space through the acquisition of Patheon.

ACF bioanalytical plant opens as cell and gene therapies reach ‘tipping point’

24-Aug-2017 By Flora Southey

ACF Bioservices has completed the construction of its Exton, Pennsylvania, US-based facility for cell and gene product testing.

Oxford Genetics secures investment; expands UK facility and eyes US market

23-Aug-2017 By Dan Stanton

Oxford Genetics will expand its bioproduction services in the UK and target the US market through an office in Boston after receiving a £7.5m ($9.6m) investment.

Agilent 'outpacing the market' with double-digit biopharma growth

22-Aug-2017 By Dan Stanton

Agilent Technologies says it is benefitting from increased antibody and biosimilar R&D and manufacturing, reporting a double-digit growth for its third quarter.

Vendors optimistic for future despite slowdown in growth

18-Aug-2017 By Dan Stanton

Bioprocessing suppliers have recently expressed optimism in the sector despite a slowdown in growth, and one expert believes this will drive investment in new tech and markets.

Bioproduction bottlenecks increasing due to staff shortages, says report

16-Aug-2017 By Dan Stanton

A shortage in expertise is causing bottlenecks in the biomanufacturing space with around half of drugmakers struggling to fill processing positions, an industry report finds.

Sanofi and Regeneron end ten-year mAb collaboration

16-Aug-2017 By Staff Reporter

“One of the most productive arrangements in the history of the biotechnology industry” will end, says Regeneron on its monoclonal antibody collaboration with Sanofi.

Reprocell grows cell and tissue-based services in Scotland

11-Aug-2017 By Flora Southey

Human tissue-focused products and services firm Reprocell Europe has opened headquarters in Glasgow, Scotland, which it says will boost business and create jobs.

US FDA clarifies what constitutes 'minor' change to biologic production process

09-Aug-2017 By Gareth Macdonald

The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week.

update

Hep B vaccine supply issues at Merck & Co and GSK prompt UK to prioritize access

08-Aug-2017 By Gareth Macdonald

Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK.

Celltrion Healthcare $890m IPO to up biosimilar inventory and broaden portfolio

04-Aug-2017 By Dan Stanton

Celltrion Healthcare will purchase more biosimilars from biomanufacturing partner Celltrion Inc. and expand its distribution network after raising one trillion Won ($888m) in an IPO.

Horizon cell line sequence released in bid to up bioproduction efficiency

02-Aug-2017 By Dan Stanton

Horizon Discovery will allow researchers to modify a genome sequence based on its knock-out CHO K1 cell line in a bid to drive innovation in bioproduction.

Modular single-use facilities rebalance Biopharma’s capacity scales

02-Aug-2017 By Dan Stanton

Modular facilities and single-use systems are fast becoming a standard part of the bioproduction infrastructure as industry looks to mitigate future capacity constraints.

Thermo Fisher: Modest Q2 for life sciences due to ‘lumpiness’ of bioproduction

01-Aug-2017 By Dan Stanton

Muted bioproduction technology pegged back an otherwise strong quarter, but Thermo Fisher says it expects growth will pick up again over time.

Lonza envisions five new plants at Visp for modular manufacturing biz

28-Jul-2017 By Gareth Macdonald

Lonza has started work on a facility to house its new modular tech-based biomanufacturing service at its site in Visp, Switzerland.

Sartorius takes €10m hit on media sales due to Lonza's regulatory woes

26-Jul-2017 By Dan Stanton

Supply chain issues stemming from an FDA warning letter at a facility run by its partner Lonza have dampened Sartorius Stedim Biotech’s first half 2017 results.

Lonza sets CHF7.5bn 2022 sales target citing pharma drivers

26-Jul-2017 By Gareth Macdonald

Lonza Group AG has predicted it will generate annual revenue of CHF7.5bn ($7.9bn) by 2022, citing recent acquisition Capsugel and its new Visp-based Ibex manufacturing service as drivers.

Exclusive interview with CEO TH Kim

Samsung Biologics: Reducing COGS could double mammalian CMO use to 50%

25-Jul-2017 By Dan Stanton

Samsung Biologics wants Big Pharma to up biomanufacturing outsourcing and says lessons learned from the semiconductor industry will give it the advantage in the CMO space.