Analytical (technologies & services)

Univercells: 'Micro-facilities' to slash the cost of vaccine manufacture

20-Oct-2017 By Cutting the cost of vaccine manufacture, Univercells

High-density single-use bioreactors, small facilities and continuous manufacturing will cut the cost of manufacturing polio vaccines down to $0.15 per dose, says Univercells.

Amgen: Industry must look to next-generation continuous cell harvesting tech

17-Oct-2017 By Dan Stanton

Amgen says it is evaluating Pall’s Cadence Acoustic Separation as a primary cell clarification method for monoclonal antibodies.

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.

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.

Teva: CIP and SIP changes extended life of Protein A resin by 50%

11-Oct-2017 By Dan Stanton

Teva says it has increased the lifespan of its Protein A resin and thus reduced the cost of manufacturing monoclonal antibodies by tweaking its cleaning materials.

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.

Biotech Week Boston

Looking for RMAT designation? Ensure your clinical evidence is up to scratch

06-Oct-2017 By Dan Stanton

Clinical evidence is the most important part of any Regenerative Medicine Advanced Therapy (RMAT) application, according to a regulatory consultant.

Irvine Scientific expansion to offer dry powder media lots up to 7,000kg

28-Sep-2017 By Dan Stanton

Irvine Scientific has expanded its cell culture dry powder facility in California to support the projected increase of biotherapeutic production.

Biotech Week Boston

On the roadmap again: Industry to address 'never ending' bioprocessing evolution

27-Sep-2017 By Dan Stanton

The Biophorum Operations Group (BPOG) has begun working on 11 technology development projects after publishing its first roadmap, but the bioprocessing industry’s visions are forever evolving, says Sanofi-Genzyme.

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.

Filling and freeze-drying drivers for $950m Cook deal says Catalent

22-Sep-2017 By Gareth Macdonald

Catalent has cited Cook’s ability to make and freeze-dry liquid drugs as major drivers for its planned takeover and said it is keen to take on the firm’s biopharma customers.

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.

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.

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).

CSL adding scalable stem cell gene therapy tech in $91m Calimmune buy

30-Aug-2017 By Dan Stanton

CSL Behring will launch itself into the stem cell gene therapy through the acquisition of Calimmune, adding a preclinical candidate and two manufacturing efficiency technologies.

CEO predicts fungal-based protein expression will be a 'CHO Stopper'

CHO platforms unsustainable for biopharma's future, says Dyadic

25-Aug-2017 By Dan Stanton

Industry is feeling the low yield and high cost limitations of the CHO cell line and must look to alternatives to make next-generation biological products, says fungal-based protein expression firm Dyadic International.

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.

EMA plans biomarker and drug-matched guidelines

17-Aug-2017 By Flora Southey

The European Medicines Agency (EMA) is working on guidelines to help drug firms to develop companion diagnostics in parallel with medicines.

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.

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.

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.

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.

Alexion ends Moderna mRNA pact

28-Jul-2017 By Flora Southey

Alexion Pharmaceuticals says it is reducing R&D operations and terminating mRNA-focused preclinical partnerships.

Pall: ‘More than ever, process control is a core focus area’

28-Jul-2017 By Dan Stanton

Pall Corporation has developed a control system for its single-use benchtop bioreactor and says it will continue to invest in-house for process control technologies.

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.

Update - comments from EMA and EFPIA

EU to probe if drug firms' pre-submission meetings sway EMA approval decisions

19-Jul-2017 By Gareth Macdonald

Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation 

Recreated pox virus may yield vaccines and expression systems say scientists

18-Jul-2017 By Flora Southey

Researchers at the University of Alberta, Canada say a synthetic version of the extinct horsepox virus could yield more efficient protein expression systems and better vaccines. 

US FDA to decide on Spark's vision loss gene therapy Luxturna in January

18-Jul-2017 By Gareth Macdonald

The US FDA has promised to review Spark Therapeutics’ candidate vision loss gene therapy Luxturna by next January.

GE Healthcare and Oritain launch testing service to combat serum fraud

12-Jul-2017 By Gareth Macdonald

Cell therapy firms will be able to authenticate the foetal bovie serum (FBS) they use through a testing programme launched by GE Healthcare and Oritain.

Spheryx awarded Ph II grant to modify tech for biologics industry

07-Jul-2017 By Melissa Fassbender

Spheryx, Inc. has been awarded a $1.5m grant over two years to support modifications to the company’s propriety protein aggregation detection and monitoring technology.

EC says Merck and Sigma-Aldrich broke M&A procedures and could face $170m fine

06-Jul-2017 By Gareth Macdonald

German Merck and Sigma-Aldrich broke EU merger procedures and could face a fine equivalent to 1% of the combined firm's annual revenue according to the European Commission

Vaccine manufacturing deviation reports up by 19% in 2016, US FDA

05-Jul-2017 By Dan Stanton

An increase of quality, process control and specification issues contributed to a rise in reported vaccine manufacturing deviations last year, a US FDA report finds.

PBL opens doors at UK bio-development centre

04-Jul-2017 By Dan Stanton

Porton Biopharma has opened a biologics characterisation and development facility at its site in the UK.

Pfizer starts work on Missouri biotherapeutics R&D hub

28-Jun-2017 By Gareth Macdonald

Pfizer is building a $200m (€179m) R&D centre in Chesterfield, Missouri at which it will consolidate biotherapeutics process development operations in the region.

Dispatches from Interphex Japan

Tokyo drift? Large molecule R&D shortfall threat to Japanese pharma, says Chugai

28-Jun-2017 By Dan Stanton

A failure to embrace biologics R&D has restricted Japanese pharma’s global growth, says CEO of Roche subsidiary Chugai Pharmaceuticals.

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.

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.

Irvine Scientific says it will build a media R&D lab at its Orange County site

14-Jun-2017 By Staff Reporter

Irvine Scientific has announced plans for an R&D centre at its site in Irvine, California citing increasing biopharma industry demand for cell culture and media regents.  

Merck & Co pauses two Ph III Keytruda studies after patient deaths

14-Jun-2017 By Gareth Macdonald

Merck & Co has halted two Phase III studies examining its drug Keytruda (pembrolizumab) in combination with other therapies after reports of patient deaths.

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.

CEO scouts top E&W Coast scientific talent to secure Merck & Co.'s future

‘Don’t underestimate Merck's vaccine business,’ says CEO

07-Jun-2017 By Dan Stanton

CEO Ken Frazier has told investors investments and partnerships, such as collaboration with messenger RNA firm Moderna Therapeutics, have bolstered Merck & Co.’s vaccine division.

A happy medium for stem cells? Irvine Scientific launches GMP xeno-free offering

17-May-2017 By Dan Stanton

Xeno-free and cGMP-manufactured media are highly desired by cell therapy developers, says Irvine Scientific as it launches a medium for hematopoietic stem and progenitor cells (HSPCs).