Disposable Manufacturing Tech

Catalent contracted to manufacture Valerion's orphan drug candidates

03-Dec-2014 By Dan Stanton

Valerion Therapeutics has inked an agreement for the manufacture of two orphan drug candidates using Catalent’s GPEx mammalian cell line platform.

Pall up on single-use and steel hybrid bioprocessing systems

26-Nov-2014 By Dan Stanton

A hybrid of disposable and stainless steel systems will remain the biomanufacturing model for the near future, says Pall reporting a robust first quarter 2015.

Amgen launches $200m biomanufacturing facility in Singapore

21-Nov-2014 By Zachary Brennan

Amgen has completed construction of its first $200m next-gen biomanufacturing facility in Singapore, which is outfitted with single-use technology to allow for greater flexibility.

Industry onboard with single-use but still 'chroma-phobic,' says EMD Millipore

19-Nov-2014 By Dan Stanton

Single-use continues to be adopted by the bioprocessing industry, but drugmakers are still hesitant to use disposable chromatography systems, says EMD Millipore.

GE sets up in Istanbul in bid to capture a share of Turkish tech market

14-Nov-2014 By Gareth Macdonald

Turkey’s efforts to increase local biopharmaceutical production have prompted GE Healthcare Life Sciences to set up a biopharmaceutical technology training centre in Istanbul.

VWR steps into world of single-use with two acquisitions

11-Nov-2014 By Zachary Brennan

Lab service provider VWR is moving into the industry of single-use bioprocessing with the acquisitions of Integra Companies and STI Components.

Amgen files FDA petition, lawsuit seeking info on Sandoz biosimilar manufacturing

07-Nov-2014 By Zachary Brennan

The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.

Dispatches from AAPS

Extractables & leachables the biggest barrier to SU adoption, says WuXi

07-Nov-2014 By Dan Stanton

Extractables & leachables are the number one problem holding back the adoption and scale-up of single-use technology, according to a WuXi Apptech Director.

Vendors' role in single-use plant design could cut costs, says M+W

04-Nov-2014 By Dan Stanton

Single-use vendors could help cut costs in designing and building biopharma facilities, according to engineering firm M+W.

Amgen chases $3bn biosimilar market with three new programs, biomanufacturing capabilities

29-Oct-2014 By Zachary Brennan

Despite plans to lay off more than 2,000 employees, Amgen is preparing for a biosimilar onslaught and expanding its portfolio to nine biosimilar programs.

Argos begins construction on new biomanufacturing facility in North Carolina

24-Oct-2014 By Zachary Brennan

Personalized immunotherapy developer Argos Therapeutics has broken ground on a new 100,000 square-foot biomanufacturing facility in Durham, North Carolina.

Single-use vendors play vital role in biopharma supply chain, says Sartorius

22-Oct-2014 By Dan Stanton

Close relationships between vendors and biomanufacturers are critical according to Sartorius, which was been awarded an accolade for the design of WuXi AppTec’s biologics production facility in China.

Dispatches from BioProcess International

Shift to single-use means end users ceding more control to suppliers, experts say

22-Oct-2014 By Zachary Brennan

As single-use technology replaces traditional stainless steel technology in biomanufacturing, suppliers will own a larger portion of the supply chain, which is creating anxiety for end users such as Pfizer and Merck, experts say.

Correction

Biotherapeutics need general chapters not individual Ph. Eur. monographs says EGA

21-Oct-2014 By Gareth Macdonald

Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.

Future trends: Rise of mAbs and fall of 20,000L bioreactors says consultant

17-Oct-2014 By Dan Stanton

Increased efficiency, local manufacturing and specialty products are driving demand for smaller more flexible facilities, according to bioprocessing consultant Howard Levine.

Sabic: Compatible plastics to cut costs and up safety in single-use bioreactors

10-Oct-2014 By Dan Stanton

Biomanufacturing costs and the risk of extractables and leachables can be reduced by developing more compatible plastics, Sabic told Biopharma-Reporter.com at CPhI in Paris.

Pre CPhI Special

How green was my Valium? Not very, despite industry claims

01-Oct-2014 By Gareth Macdonald

Making active pharmaceutical ingredients (API) is a dirty business and you’d have to be pretty green to believe claims drug industry 'demand' will create a $100bn market for environmentally-friendly production methods by 2020.

Mega deals like Merck-Sigma cut biopharma bargaining power says leading CMO

24-Sep-2014 By Gareth Macdonald

Life science sector consolidation is a concern for some biomanufacturers, who say mega mergers like Merck KGaA’s $17bn acquisition of Sigma-Aldrich will limit their ability to negotiate on prices.

RLS to make India's first Remicade biosimilar for Epirus and Ranbaxy

23-Sep-2014 By Dan Stanton

Reliance Life Sciences has been contracted to make the first Indian biosimilar of J&J’s Remicade (infliximab), though Epirus Biopharmaceuticals says it is looking to Fujifilm for its European supply.

Greenpeace: Industry needs greener disposal methods for single-use systems

12-Sep-2014 By Dan Stanton

Common environmentally practices for single-use systems must be adapted before industry “becomes too set in its ways,” says Greenpeace, despite biocontamination currently impeding recycling efforts.

Sartorius on environmental concerns: 'Single-use is greener, if not cleaner'

03-Sep-2014 By Dan Stanton

The environmental impact of single-use biosystems remains lower than stainless steel despite difficulties in the disposal of bioreactor bags, says Sartorius.

Single-use growth outpacing stainless steel, says acquisition-hungry Pall

29-Aug-2014 By Dan Stanton

Acquisitions in the single-use tech space helped drive growth in fiscal 2014 according to Pall, which plans to continue its two-pronged M&A strategy.

Yearning for Yen? Merck Millipore bids to boost Japanese biz with test centre

27-Aug-2014 By Gareth Macdonald

Merck Millipore has set out to win more biomanufacturing business in Japan by consolidating testing and technical operations in the country into a newly expanded Tokyo training hub.

Progenics selects Gallus to manufacture its mAb in Phase II trial

22-Aug-2014 By Zachary Brennan

Oncology-focused Progenics Pharmaceuticals has selected CMO Gallus BioPharmaceuticals to manufacture the anti-prostate specific membrane antigen (PSMA) monoclonal antibody used in Progenics’ PSMA ADC product candidate.

For single-use, 2,000 litres is Fujifilm's limit as it invests in US and UK

19-Aug-2014 By Dan Stanton

Single-use bioreactors do not need to be bigger than 2,000L says Fujifilm Diosynth, which is investing in such technology at plants in the UK and US

Miltenyi Biotec acquires lentiviral vector manufacturing business of Lentigen

19-Aug-2014 By Zachary Brennan

Miltenyi Biotec has acquired the lentiviral vector manufacturing business and related assets from Lentigen, a lentiviral technology provider for cell and gene therapy applications.

US FDA approves first needle-free flu vaccine delivery system

19-Aug-2014 By Zachary Brennan

For the first time ever, the US FDA has approved a needle-free injection system to deliver the seasonal flu vaccine.

Carbogen Amcis takes over Swiss plant to boost ADC offering

08-Aug-2014 By Dan Stanton

Carbogen Amcis has expanded its operations in light of unrelenting demand for antibody-drug conjugate (ADC) services by signing a long-term lease for a facility in Switzerland.

Redbiotec picks GE's single-use systems for Herpesvirus vaccine production

05-Aug-2014 By Dan Stanton

Redbiotec has selected GE Healthcare’s single-use processing offering to aid development of its Herpesvirus vaccines which use viral antigen complexes and virus-like particles.

Single-use and M&As drive double-digit growth for Sartorius

23-Jul-2014 By Dan Stanton

Sartorius Stedim Biotech has attributed strong sales and order growth in the second quarter 2014 to recent acquisitions and demand for single-use products.

Brazilian JV looks to tap plant-based manufacturing system for biosimilars

23-Jul-2014 By Zachary Brennan

Biologic manufacturer PlantForm and PharmaPraxis have established a joint venture to develop, manufacture and commercialize biosimilar versions of six key biopharma treatments.

Correction

Protein A OK! Repligen predicts growth in suit with MAb industry

22-Jul-2014 By Dan Stanton

Interest in creating alternatives to Protein A has waned in light of more viable cost-saving opportunities in bioprocessing, such as single-use adoption, says Repligen.

Repligen: New CFO 'suited to growth path,' hints at acquisitions

18-Jul-2014 By Dan Stanton

Protein A manufacturer Repligen has hired a CFO and says it is on the lookout for acquisition opportunities.

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).

Fourth times the charm? Abbvie re-ups offer to buy Shire for £30bn

09-Jul-2014 By Zachary Brennan

AbbVie has once again raised its bid to purchase Shire – this time by about 11% to £30.1bn ($51bn).

Protein A here to stay according to GE Healthcare

25-Jun-2014 By Gareth Macdonald

Protein A will keep its key role in therapeutic mAb production but next generation biotherapeutics will see Protein L become increasingly import says GE Healthcare.

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.

Meissner: Nothing holding back single-use as it expands filtration ops

10-Jun-2014 By Dan Stanton

Nothing is holding back the adoption of single-use filtration products says Meissner, which has expanded its facility in California.

Rentschler doubles capacity with new single-use bioreactor

10-Jun-2014 By Zachary Brennan

German CMO Rentschler Biotechnologie GmbH is adding a 2,000 L single-use bioreactor to its facility in Laupheim, Germany, which it expects to be fully operational by the end of the first quarter of 2015.

Glenmark opens mAb manufacturing facility in Switzerland

06-Jun-2014 By Zachary Brennan

Glenmark Pharmaceuticals has opened a new cGMP-compliant monoclonal antibody (mAb) manufacturing facility in La Chaux-de-Fonds, Switzerland.

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.

Repligen 'Refines' high yield fermentation system in $25m acquisition

04-Jun-2014 By Dan Stanton

Repligen has added the “gold standard” of fermentation cell retention technology to its portfolio, and says it will develop it further to support the rise in single-use.

Pall up on downstream as ATMI boosts sales but cuts margin

30-May-2014 By Dan Stanton

Pall says the acquisition of ATMI helped grow biopharmaceuticals sales 13% year-over-year, but negatively impacted gross margin for the third quarter.

Biopharma wary of disposable systems for large-scale production... for now

28-May-2014 By Dan Stanton

Janssen has mirrored Pfizer’s concerns about the scale, price and robustness of using single-use technology for high-volume production but says industry collaboration could help bring standards in place.

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."

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.

DISPATCHES FROM THE BIOLOGICAL PRODUCTION FORUM, DUBLIN

Pfizer stays stainless saying single-use cost burdens high volume production

14-May-2014 By Dan Stanton

Single-use technology for high volume biomanufacturing is riddled with problems and will only be fully implemented by industry once the cost drops, according to Pfizer.

Dispatches from the Biological Production Forum, Dublin

Sartorius: QbD for single-use systems could help assure quality

13-May-2014 By Dan Stanton

Though industry has fully embraced single-use, manufacturers of such systems need to remove the risk of extractables and leachables and control the supply process according to Sartorius.

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...