Bio-Outsourcing

Netherlands to help India develop, mass produce measles-rubella vaccine

10-Jun-2015 By Zachary Brennan

The Netherlands and India have signed a MOU (Memorandum of Understanding) under which a government-based institute of the Netherlands will extend technical support for the development and manufacturing of the measles-rubella vaccine.

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Data from all UK-funded vaccine trials to be published says PM

10-Jun-2015 By Gareth Macdonald

Results from all UK-funded vaccine trials will be made public according to Prime Minister David Cameron, who suggested failure to share data exacerbated the Ebola outbreak.

Single-use demonstration sites 'needed more than ever' says Sartorius

09-Jun-2015 By Dan Stanton

Sartorius says application centres are integral to demonstrate its single-use technologies as it opens a third in New York.

Intertek to open new lab in light of pharma demand for immunochemistry

05-Jun-2015 By Gareth Macdonald

Intertek will open an immunochemistry lab in Manchester, UK to cater for growing demand for specialised analytical services from biologics and biosimilars developers.

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The age of phage? World first cGMP certification for phage therapy plant

03-Jun-2015 By Gareth Macdonald

AmpliPhi Biosciences’ phage-based antibacterial therapies plant in Ljubljana has been deemed to meet manufacturing standards by Slovenian regulators.

Pluristem outlines cell therapy production plan after securing patents in future markets

02-Jun-2015 By Gareth Macdonald

Pluristem Therapeutics will set up manufacturing sites and find local partners to make cell therapies for the Chinese, Korean, Mexican, Russian and Israeli markets after securing various patents this week.

Unique biologics pipelines driving biomanufacturing innovation, Deloitte says

02-Jun-2015 By Zachary Brennan

The adoption of new technologies related to single-use bioreactors, disposable plastic containers, continuous purification processing, and real-time quality analysis are driving the next generation of biomanufacturing, according to a new report from the...

Alligator picks Cobra for cell line development of antibody candidate

02-Jun-2015 By Dan Stanton

Phase I trials of a candidate mAb cancer drug shows that regulators accept UCOE-based cell line engineering says Cobra Biologics.

3D printed scaffold could free diabetic cell transplant recipients from immunosupressive meds

28-May-2015 By Gareth Macdonald

Dutch scientists have 3D printed a protective scaffold that could make cell transplant-based diabetes treatment more successful and eliminate the need for immunosupressive drugs.

Biomay to use VTU's yeast-based tech for its allergen pipeline

26-May-2015 By Dan Stanton

Biomay has licensed a yeast-based expression system from fellow Austrian biotech VTU Technologies to use for the commercial production of its recombinant allergens.

Thermo Fisher's $15bn war chest set to further consolidate industry

22-May-2015 By Dan Stanton

Danaher's acquisition of Pall will not change the competitive landscape in the bioprocessing tech industry says Thermo Fisher, as it earmarks $10bn for further M&A activity.

Biologics and R&D investment driving freeze-drying demand says Symbiosis

21-May-2015 By Gareth Macdonald

Biologics and focused R&D spending are driving the market for lyophilisation according to Symbiosis Pharmaceutical Services, which says its freeze-drying tech investment reflects this surge in demand.

Inhalable biologics: Serendex formulates with Novozymes’ Recombumin

20-May-2015 By Fiona BARRY

Serendex Pharmaceutical is a step closer to developing an inhalable biopharmaceutical for lung disease after adopting stabilising tech from Novozymes.

Catalent to use GPEx cell line tech to make Amarantus' protein candidate

18-May-2015 By Dan Stanton

Amarantus BioScience has selected Catalent to make the protein mesencephalic-astrocyte-derived neurotrophic factor (MANF) for its Phase I candidate.

SAFC expands ADC and bulk drug manufacturing in CA, MO

13-May-2015 By Fiona BARRY

SAFC has announced investments in gene therapy manufacturing sites in Missouri and California.

Rumoured $13bn Pall sale could spark M&A flurry, says analyst

12-May-2015 By Dan Stanton

The acquisition of Pall Corporation by either Thermo Fisher or Danaher could spur further M&A in the life science tech industry, according to an analyst.

NJ Assembly committee approves biosimilar substitution bill

12-May-2015 By Zachary Brennan

Under the bill first proposed in 2014, which won unanimous approval last week from a New Jersey Assembly committee, pharmacists would have to notify prescribers within five days of dispensing an interchangeable biosimilar.

US FDA finalizes three guidance documents tied to biosimilar science, quality

05-May-2015 By Zachary Brennan

With the release of three final guidance documents on biosimilars, the FDA is offering more clarity for developers seeking to fine-tune their understanding of the science and quality of biosimilars.

Lonza predicts growth despite strong Swiss franc in 2015

29-Apr-2015 By Gareth Macdonald

Lonza has predicted that revenues and profits will grow in 2015 despite the strong franc, citing pharma portfolio optimization and demand for outsourced manufacturing services.

Lilly to sell California biomanufacturing plant

28-Apr-2015 By Zachary Brennan

Eli Lilly has hired CBRE Group to sell its biomanufacturing plant in Vacaville, California, which it claims is one of the largest bulk API manufacturing facilities for recombinant microbial-based biopharmaceuticals in the US. 

Celgene in $450m deal to commercialise MedImmune's anti-PD-L1 candidate

28-Apr-2015 By Dan Stanton

AstraZeneca has inked a development and commercialisation deal with Celgene for its haematology programmed cell death ligand 1 (PD-L1) candidate, MEDI4736.

Bio-CMO sector to grow over 40% on Big Biopharma's burgeoning pipelines

24-Apr-2015 By Dan Stanton

Cheaper disposable manufacturing techs and increased demand for outsourced production will see more CMOs enter the contracting sector according to HighTech Business Decisions

Sigma-Aldrich opens doors to latest Singapore biopharma investment

22-Apr-2015 By Dan Stanton

Sigma-Aldrich has opened a cell culture Technical Center in Singapore and plans to expand further in the city-state with a cGMP distribution site.

US arthritis patients will still face high costs when biosimilars are available says researcher

21-Apr-2015 By Gareth Macdonald

US rheumatoid arthritis (RA) sufferers will still face high drug prices after biosimilar are available unless insurers reclassify such meds according to the author of research on biologic DMARD costs.

CMOs earn €8.4m in EU grants to help scale-up manufacturing of thermo-stable vaccines

20-Apr-2015 By Zachary Brennan

A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.

Sartorius adds biologics testing through acquisition of CRO BioOutsource

17-Apr-2015 By Dan Stanton

Sartorius has expanded its biopharma services to include contract testing by buying CRO BioOutsource.

Dispatches from BPI 2015

Pfizer's vetting process sorts the strategic CMOs from the casual flings

15-Apr-2015 By Dan Stanton

Looking for a full-on partnership with Pfizer or a no-strings-attached manufacturing deal? Either way prepare for a tough screening process and don't be located too far from an airport.

Almac to relocate protein business to up capacity and add new services

13-Apr-2015 By Gareth Macdonald

Almac will transfer its custom peptide manufacturing business to a site at the Edinburgh Technopole business park in Scotland’s capital in a £3.5m move designed to expand capacity.

Targacept-Catalyst merger in review as Pfizer exits Factor VII collaboration

10-Apr-2015 By Dan Stanton

Pfizer’s termination of a partnership to develop Factor VIIa products may have implications in the recently announced merger of Catalyst Biosciences with Targacept.

Netherlands Medicines Evaluation Board says no ‘relevant differences’ between biosimilars, reference products

08-Apr-2015 By Zachary Brennan

The Medicines Evaluation Board (MEB) of the Netherlands has updated its position about biosimilars, saying the relatively new products “have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality,...

Super-sensitive protein measurement assay for CRO Eurofins

07-Apr-2015 By Fiona BARRY

Eurofins Bioanalytical Services has announced it will offer an extra-sensitive immunoassay service for biopharma developers.

US military strikes deal to secure adenovirus shots from Teva

03-Apr-2015 By Dan Stanton

Supply of the Adenovirus Type 4 and Type 7 Vaccine to all US military personnel has been secured through a five-year contract with Teva worth $170m (€156m).

GSK to begin Bexsero roll-out after striking deal with UK Government

01-Apr-2015 By Dan Stanton

GSK expects to begin supplying the UK with meningitis B vaccine Bexsero later this year after reaching an agreement on price.

Japan's yen for regenerative meds: Fujifilm to buy Cellular Dynamics

01-Apr-2015 By Gareth Macdonald

Fujifilm will buy Cellular Dynamics International (CDI) for $307m to add induced stem cells to its offering and further build in regenerative medicines.

EMA: TTIP and inspection databases a way of improving global manufacturing standards

31-Mar-2015 By Gareth Macdonald

Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.

UK politician pledge would ban 89% of animal research, say scientists

31-Mar-2015 By Fiona BARRY

British MPs have signed an anti-animal cruelty pledge which scientists warn would “cripple” disease research and outlaw 89% of preclinical animal research.

Georgia biosimilar substitution bill calls for labeling changes, heads to Governor for signature

30-Mar-2015 By Zachary Brennan

A Georgia bill, which passed both the state House and Senate last week, calls for new language on biosimilar labels that say that the product is “interchangeable.”

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Novasep joins Lonza as Mydicar API producer in deal with Celladon

25-Mar-2015 By Gareth Macdonald

Novasep and Lonza will both make the API for Celladon's heart attack therapy, Mydicar.

AbbVie bucks Puerto Rico departure trend with $30m expansion

25-Mar-2015 By Fiona BARRY

AbbVie is investing $30m (€27m) in contract manufacturing facilities in Puerto Rico and plans to create 100 jobs over the next two years.

$20m Takeda-ImmunoGen licensing deal for cancer ADCs

25-Mar-2015 By Fiona BARRY

Takeda has licensed technology from ImmunoGen to make two antibody drug conjugates (ADCs) targeting cancer.

Good news for Sandoz? GSK confident UK will accept Bexsero price proposal

24-Mar-2015 By Gareth Macdonald

Speculation GSK's meningitis B vaccine Bexsero will soon be available on the UK National Health Serivice will be welcomed by campaigners, protein supplier Sandoz and its parent company, Novartis.

Rentschler brings single-use system online

23-Mar-2015 By Gareth Macdonald

Rentschler Biotechnologie has increased single-use bioreactor capacity at its manufacturing site in Laupheim, Germany and is moving forward with plans to invest €25m ($27m) in a new stainless steel system in the next few months.

Athersys and Chugai partner on stem cell therapy for stroke

20-Mar-2015 By Fiona BARRY

Athersys and Chugai Pharmaceutical have announced a partnership and license agreement to exclusively develop and commercialize MultiStem cell therapy for ischemic stroke in Japan.

Animal rights protests have had little impact on preclinical services sector say CROs

17-Mar-2015 By Gareth Macdonald

Animal rights protests have not hurt the non-clinical services sector according to leading CROs which say vital drug development work has continued.

Selvita offers more protein services to help biosimilars makers

17-Mar-2015 By Fiona BARRY

Polish preclinical services company Selvita has expanded its protein target offerings and will allow companies to characterise rivals’ biologics.

NC introduces biosimilar substitution bill as MA looks to amend its law

12-Mar-2015 By Zachary Brennan

North Carolina is jumping on the biosimilar substitution legislation bandwagon with a new bill unveiled this week, while Massachusetts is looking to slightly tweak its law.

Biobetters may fare better than biosimilars in some therapeutic areas, says analyst

11-Mar-2015 By Gareth Macdonald

Biobetters stand a better chance of winning market share than lower cost biosimilars in some indications according to new analysis.

Orgenesis buys cell therapy CMO to cut manufacturing costs and diversify revenue stream

11-Mar-2015 By Gareth Macdonald

Orgenesis has bought Masthercell SA to take control of production of its Type 1 diabetes cell therapy candidate ahead of clinical trials.

CDMO Rottendorf signs five new projects with top biopharma companies

06-Mar-2015 By Zachary Brennan

Chicago-based Rottendorf Pharmaceuticals, a top 20 contract development and manufacturing organization (CDMO), has signed three formulation development projects and two commercial transfer projects with multiple top pharma and biotech companies in the...

UK R&D firm patents biologics powder storage technique

27-Feb-2015 By Fiona BARRY

XstalBio, a private biopharma services company, has patented the use of stabilisers in the manufacture of dry powders for biopharmaceuticals – an alternative to freeze-drying or spray-drying techniques.