Bio-Outsourcing

Dispatches from BioPharma Expo, Japan

Lonza expands in Asia: 8,000L single-use in Singapore, regenerative meds in Japan

30-Jun-2017 By Dan Stanton

Lonza will install four 2,000L single-use bioreactors at its Singapore facility to cater for growing demand for small to mid-volume biologics production.

Lonza’s $5.5bn Capsugel takeover cleared by regulators

27-Jun-2017 By Gareth Macdonald

Lonza expects to complete its $5.5bn (€5.2bn) takeover of Capsugel SA in the next few days having secured approval from competition authorities around the world.

US FDA rejects Pfizer's Epogen biosimilar citing McPherson site warning

23-Jun-2017 By Gareth Macdonald

Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.

Takeda prepping to take over EU production of stem cell therapy from 2021

23-Jun-2017 By Dan Stanton

Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohn’s disease stem cell therapy licensed from TiGenix.

ImmunoCellular Therapeutics halts brain cancer cell therapy trial due to lack of cash

22-Jun-2017 By Gareth Macdonald

ImmunoCellular Therapeutics Ltd has halted a Phase III trial of its brain cancer cell therapy ICT-107 due to a lack of funds and is looking for a buyer or partner for the programme.

TxCell hires Lentigen to make vectors used to produce its organ rejection cell therapy

20-Jun-2017 By Gareth Macdonald

TxCell SA has hired Lentigen Technology Inc. to make the vectors it uses to make its T-cell transplant rejection therapy.

Cell Medica buys T cell receptor cancer candidate from UK Catapult

20-Jun-2017 By Dan Stanton

Cell Medica says it will work with the Cell and Gene Therapy Catapult to assess automation and processing technologies involved in scaling-up the acquired cancer candidate.

Wuxi Biologics IPO in Hong Kong brings in $511m

16-Jun-2017 By Staff Reporter

Wuxi Biologics (Cayman) Inc. completed a successful IPO on the Hong Kong stock exchange on Tuesday, raising $511m.

Roche accused of charging too much for Herceptin in South Africa

13-Jun-2017 By Gareth Macdonald

Roche has been accused of charging too much for its breast cancer drug trastuzumab by South African competition authorities.

Lonza plugs EU cell and gene therapy manufacturing gap through PharmaCell buy

09-Jun-2017 By Dan Stanton

The acquisition of Dutch commercial cell and gene therapy maker PharmaCell places Lonza as the leading CDMO in the space, the firm says.

Flexing one's (bispecific) Abs: Merck ups F-star deal, EpiMab contracts WuXi

07-Jun-2017 By Staff Reporter

Germany’s Merck expands its partnership with F-star and EpimAb Biotherapeutics contracts WuXi Biologics. Welcome to our round-up of bispecific antibody news.

Orchard Therapeutics hits up Hitachi CDMO to make autologous gene therapy

06-Jun-2017 By Staff Reporter

Hitachi Group subsidiary PCT Cell Therapy Services will provide clinical manufacturing services for Orchard’s autologous gene therapy for the treatment of adenosine deaminase deficiency.

Securing single-use systems: SSB opts for blockbuster resins and supplier partnerships

06-Jun-2017 By Dan Stanton

Single-use vendors must address their own supply chains to help overcome end-user challenges, says Sartorius.

Patheon to manufacture amyloidosis antibody treatment for Caelum

02-Jun-2017 By Flora Southey

Caelum Biosciences has selected Patheon to make its lead antibody CAEL-101 to treat orphan disease amyloid light-chain (AL) amyloidosis.

Horizon and ATUM combine tech to offer stable cell line production

02-Jun-2017 By Dan Stanton

Horizon Discovery will add vector and transposase technology to its gene editing services through a cross-licensing partnership with gene and protein expression services firm ATUM.

Lithuania's Biotechpharma jumps on the 2,000L single-use seed train

30-May-2017 By Dan Stanton

 Lithuanian CDMO Biotechpharma has completed a €15m ($16.7m) expansion adding more than 2,500L of single-use bioreactor capacity.

LSNE tapped for drug substance manufacturing, fill/finish services

25-May-2017 By Melissa Fassbender

LSNE Contract Manufacturing has signed a manufacturing supply agreement with Selecta Biosciences, Inc. through which the CDMO will advance Selecta’s lead candidate, SEL-212.

Thermo Fisher: $7.2bn Patheon sits in sweet spot for bioproduction business

17-May-2017 By Dan Stanton

Thermo Fisher says Patheon will become the most competitive biologics CDMO in the market through direct access to its bioprocessing technologies and capabalities.

Boehringer Ingelheim opens Shanghai contract biomanufacturing plant

16-May-2017 By Gareth Macdonald

Boehringer Ingelheim says the biologics plant it opened in Shanghai, China today will cater for customers targeting local and international markets.

Single-use making its mark in India as Stelis teams with MilliporeSigma

16-May-2017 By Dan Stanton

Stelis Biopharma has partnered with Germany’s Merck on a bioprocessing services centre in Bangalore and says single-use systems could kickstart India’s biomanufacturing sector.

Avantor to spend $6.4bn on VWR acquisition

12-May-2017 By Flora Southey

Avantor has agreed to purchase independent laboratory product, supply chain and service provider VWR for approximately $6.4bn (€5.9bn), reflecting a share price of $33.25.

Brammer invests in commercial-ready gene therapies

10-May-2017 By Flora Southey

Brammer Bio says its commercial-scale gene therapy manufacturing facility in Cambridge, Massachusetts, US, will open in the second half of 2017.

WuXi using Thermo Fisher to equip 28,000L single-use site in China

09-May-2017 By Dan Stanton

A WuXi Biologics facility tipped to be the world’s largest single-use mammalian cell culture site will be equipped with disposable systems from Thermo Fisher.

Catalent: biologics contracting still major growth driver in Q3

05-May-2017 By Gareth Macdonald

Biologics contracting drove growth in fiscal Q3 according to Catalent, which predicted the proportion of revenue it generates from large molecule work will continue to increase.

Shire using Baxalta network to bring 30% Cinryze production in-house

05-May-2017 By Dan Stanton

Shire has begun adding capability within its own network to manufacture the Hereditary Angioedema (HAE) product Cinryze, currently being made by Dutch CMO Sanquin.

BPI Europe 2017

Cost-cutting oral vaccine tech will make Vaxart less reliant on CMO

04-May-2017 By Dan Stanton

Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.

update - WHO outlines biosimilarity requirements and inspection plan

WHO plans biosimilar prequalification scheme to increase access to cancer meds

04-May-2017 By Gareth Macdonald

The WHO has announced plans to extend its prequalification scheme to include cancer biosimilars and says it will pressure industry for fairer prices for all biologics.

Astrazeneca and Pieris team to develop mAb-like drugs for lung diseases

03-May-2017 By Gareth Macdonald

Astrazeneca has teamed up with Pieris Pharmaceuticals Inc to develop antibody like mini proteins for the treatment of lung diseases.

PharmaCell to make autologous cell therapies for Lion Biotech

28-Apr-2017 By Flora Southey

Dutch contract manufacturer PharmaCell B.V has signed a three-year Manufacturing Services Agreement to make cancer cell therapies for Lion Biotechnologies.

Thermo Fisher collaborates to establish single-use and automation site in China

27-Apr-2017 By Dan Stanton

Mab-Venture Biopharma has entered a collaboration to establish an antibody development and production plant in China incorporating Thermo Fisher’s single-use bioreactors and SmartFactory automated technology.

update

US FDA warns Lonza about Walkersville site

25-Apr-2017 By Gareth Macdonald

The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.

DISPATCHES FROM BPI EUROPE 2017

Getting a feel for biomanufacturing at the Biotech Training Facility

25-Apr-2017 By Dan Stanton

Hands-on teaching offers drugmakers, vendors and regulators a better understanding of bioprocessing, according to the managing director of a training facility in Leiden, The Netherlands.

Infographic

Hey big vendor... Is bioprocessing consolidation good for the end-user?

19-Apr-2017 By Dan Stanton

Price hikes and lack of innovation, or better buying power and end-to-end services? Experts are split on supplier M&A and its effect on biomanufacturers.

Synpromics announces £5.2M British investment in gene therapy tech

19-Apr-2017 By Flora Southey

Scottish synthetic biology firm Synpromics has received £5.2M ($6.6M) to enhance its synthetic promoter design technology used in gene therapy development.

DHL looks to strengthen presence in South American market

18-Apr-2017 By Flora Southey

Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes. 

Cobra to boost gene therapy and CAR-T capacity through £15m investment

18-Apr-2017 By Gareth Macdonald

Cobra Biologics has said it will spend £15m ($19m) to increase gene therapy production capacity, citing customer demand and market opportunities.

Fujifilm invests $130m in CDMO business, ups mammlian bioreactor capacity 70%

18-Apr-2017 By Dan Stanton

Fujifilm has invested around $130m into facilities in the US and UK weeks after launching its biopharma CDMO business.

GE aiming to be cell therapy production services one-stop-shop

12-Apr-2017 By Dan Stanton

GE Healthcare has acquired cryopreservation technology firm Asymptote and says more investments are likely as it builds an “end-to-end ecosystem” for cellular therapy production services.

Speed, yield and quality critical for cell line development, says ATUM

12-Apr-2017 By Dan Stanton

ATUM has launched itself into the mammalian cell line development space after being awarded patents for its Leap-In transposase genome technology.

GE Healthcare teams with CBMG to develop CAR-T and stem cell production tech

11-Apr-2017 By Gareth Macdonald

GE Healthcare has agreed to help Cellular Biomedicine Group (CBMG) develop CAR-T and stem cell production technologies to support its aim of making 10,000 cancer cell therapies a year. 

Selling cell thawing: Medcision launches early adopter scheme to push tech

07-Apr-2017 By Gareth Macdonald

Medcision has started pushing its cell therapy thawing technology through an early adopter scheme designed to encourage adoption by firms with candidates in trials.

RESPECT: find out what it means to ADCs, says Eisai subsidiary

07-Apr-2017 By Dan Stanton

Morphotek Inc has launched an antibody-drug conjugate (ADC) services business incorporating its RESPECT site-specific conjugation technology and eribulin-linker toxin platform.

Lonza confirms drug firm was biggest customer in 2016

31-Mar-2017 By Gareth Macdonald

Lonza's biopharma business grew faster than other divisions in 2016 with a drug firm becoming the Swiss life science supplier's biggest customer for the first time since 2013

Emisphere set to benefit as Novo Nordisk pushes oral diabetes pipeline

30-Mar-2017 By Dan Stanton

Novo Nordisk’s focus on developing oral versions of semaglutide and four other diabetes drugs could net drug delivery firm Emisphere over $200m.

Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT'

24-Mar-2017 By Dan Stanton

Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

'One-litre bioreactor scale currently the maximal for stem cell expansion and differentiation'

Industry needs new bioreactor and monitoring tech for stem cell scale-up, expert

24-Mar-2017 By Dan Stanton

Stem cell therapy developers are lacking production scale-up technologies, says the chair of an upcoming conference bringing industry and academia together to address the problem.

Eurofins pumping $5m into a UK biopharmaceutical testing site

24-Mar-2017 By Dan Stanton

Eurofins will expand its UK biopharmaceutical testing offering through a £4m ($5m) facility in Livingston, Scotland.

Goodwin Biotech to work on opioid addiction vaccines project

22-Mar-2017 By Dan Stanton

Contract manufacturer Goodwin Biotechnology will work with Minneapolis Medical Research Foundation (MMRF) to develop vaccines to treat opioid addiction.

Lonza launches liver cells for biopharma research

17-Mar-2017 By Staff reporter

Lonza has launched a new range of cryopreserved liver cells for biopharmaceutical companies that want to assess the toxicity of their drugs.

Roquette aims to up its biologic reagent presence

17-Mar-2017 By Staff Reporter

Roquette says investments in packaging, documentation and testing requirements have helped the firm move into the biologics excipient and reagent space.