Bio-Outsourcing

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.

EMA rejigs biosimilar guidelines to help developers avoid repeating trials

31-Oct-2014 By Gareth Macdonald

Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week. 

B-MS extends biologics manufacturing contract with Lonza

31-Oct-2014 By Zachary Brennan

Bristol-Myers Squibb (B-MS) and Lonza on Thursday announced a multi-year expansion of their existing biologics manufacturing agreement. 

Fujifilm to buy BARDA contractor Kalon Therapeutics

28-Oct-2014 By Gareth Macdonald

Texas, US-based GSK influenza vaccine partner Kalon Therapeutics has agreed to a takeover by Japanese conglomerate Fujifilm.

CSL pays $275m to acquire Novartis’ flu vaccines, three manufacturing sites

28-Oct-2014 By Zachary Brennan

CSL Limited has agreed to acquire Novartis’ flu vaccine business for $275m (€216m), which includes manufacturing facilities in the US, UK and Germany.

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.

MedImmune teams with UK academics on neurodegenerative disease research

16-Oct-2014 By Gareth Macdonald

MedImmune’s neurodegenerative disease partnership with the University of Cambridge is about working with “great scientists with great brains” according to a spokeswoman for parent company, AstraZeneca.

Sigma-Aldrich signs microbial growth system distribution deal with BioSilta

15-Oct-2014 By Dan Stanton

Despite a $17bn bid from Merck KGaA, it’s “business as usual” at Sigma-Aldrich which has signed a distribution agreement with reagent-based microbial growth systems firm BioSilta.

Biosimilars going global but EMA still setting the regulatory pace

15-Oct-2014 By Gareth Macdonald

Biosimilars may be a global business, but the EMA is still setting the pace when it comes to regulations according to UK contractor, BioOutsource.

Apollo launch boosts Fujifilm's mammalian expression services

10-Oct-2014 By Dan Stanton

Fujifilm has launched a mammalian cell line it says can deliver titers up to 3g/L before subsequent optimisation and will complement its microbial-based platform.

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.

SAFC, Baxter partner to offer ADC contract manufacturing

26-Sep-2014 By Zachary Brennan

SAFC and Baxter’s BioPharma unit are working together to contract manufacture ADCs (antibody drug conjugates) for biopharma companies.

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.

Emergent scales up manufacturing of anthrax vaccine

24-Sep-2014 By Zachary Brennan

Emergent BioSolutions has initiated a non-clinical study to demonstrate it can scale-up production of its anthrax vaccine, BioThrax, without making it less effective.

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.

update #2 - Regeneron to appeal

Of mice and mAbs: EPO revokes Regeneron patent after Kymab and Novo appeal

19-Sep-2014 By Gareth Macdonald

European authorities have revoked a Regeneron patent covering a genetic modification technique used to generate mouse monoclonal antibody (mAb) production platforms after an appeal by several European firms.

'Fastest way to biosimilar approval? As the CRO flies,' says industry group

17-Sep-2014 By Dan Stanton

Almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO).

Merck KGaA is latest bi-curious antibody developer in ADC deal with Sutro

17-Sep-2014 By Gareth Macdonald

Merck KGaA has partnered with bispecific antibody firm Sutro Biopharma to develop and produce antibody drug conjugates (ADCs).

Dispatches from ChemOutsourcing

CMO consolidation: Do biopharma partners see any benefits?

17-Sep-2014 By Zachary Brennan

As contract manufacturers continue to consolidate, some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies. 

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.

Seattle Genetics, Genmab enter ADC collaboration worth up to $211m

12-Sep-2014 By Zachary Brennan

Seattle Genetics and Genmab have entered into another antibody-drug conjugate (ADC)partnership under which Genmab will pay $11m upfront for use of Seattle’s auristatin-based ADC technology. 

Advanced Cell Technology wins US patent for dendritic cell manufacturing process

10-Sep-2014 By Zachary Brennan

Regenerative medicine company Advanced Cell Technology (ACT) has been issued a US patent from the US Patent and Trademark Office covering methods of manufacturing dendritic cells using a scalable process involving a renewable stem cell source as the starting...

Protalix shares soar… then dive after Ebola drug comments

09-Sep-2014 By Fiona BARRY

Protalix shares rocketed 18% then reversed in one weekend after the Israeli protein manufacturer clarified it is not in talks to produce Ebola drug ZMapp.

Analyst: CMOs to prosper as biopharma reduces capacity sharing

09-Sep-2014 By Dan Stanton

Biopharma firms are no longer offering spare capacity to rivals, according to an analyst, who says the trend is benefiting large CMOs.

Shifting pipelines drive AMRI to expand protein expression services

05-Sep-2014 By Dan Stanton

AMRI has added protein expression and purification services to its drug discovery services citing the shift in pipelines towards larger molecule drugs as a driver.

CMO Kentucky Bioprocessing grows Ebola mAb from tobacco

02-Sep-2014 By Fiona BARRY

ZMapp, the experimental Ebola therapy given to a handful of infected patients in West Africa, is being produced in tobacco plants for Mapp Biopharmaceutical by CMO Kentucky Bioprocessing in collaboration with drugmaker Defyrus.

Reinspection lands Alexion with 483 for Soliris plant

26-Aug-2014 By Dan Stanton

A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.

EMD Millipore to supply Samsung's Yervoy plant in 10-year deal

26-Aug-2014 By Gareth Macdonald

EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.

Ampio shares tumble as albumin-derived trial drug suffers case of the chills

22-Aug-2014 By Dan Stanton

Ampio Biopharmaceuticals will delay the release of Ampion trial data after discovering the drug was damaged by temperature fluctuations during shipment.

Vast majority of ADC manufacturing outsourced, report finds

22-Aug-2014 By Zachary Brennan

Between 70-80% of ADC (antibody drug conjugate) manufacturing is performed by CMOs, according to a new report.

Lonza not asked for back taxes following decision to close Hopkinton site

19-Aug-2014 By Gareth Macdonald

Lonza has not been asked to pay back taxes after abandoning plans to expand its biologics plant in Hopkinton, Massachusetts last year.

Physician groups call for separate names for biosimilars, reference biologics

19-Aug-2014 By Zachary Brennan

The American Academies of Clinical Endocrinologists, dermatologists and neurologists, as well as eight other physician groups and a number of individual physicians are calling for unique names for biosimilars to better track adverse events and ensure...

Institutional investors decry US battle over biosimilars

12-Aug-2014 By Zachary Brennan

As Celltrion announced Monday that it filed the first monoclonal antibody for approval with the US FDA, investor groups are crying foul over some of the tactics used by others in industry to discourage the uptake of biosimilars in the US.

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.

BioLife: Freeze media sales to grow as more biologics enter market

08-Aug-2014 By Dan Stanton

Second quarter sales of cryopreservation media grew 14% but BioLife Solutions says it expects revenues to skyrocket as clients’ biologics move out of the clinical stage..

Biosimilar preclinical demand growing as US market beckons, says Harlan

07-Aug-2014 By Dan Stanton

US demand for biosimilar preclinical services is expected to rocket on the back of the US FDA’s acceptance of Sandoz’s biosimilar filing, according to Harlan Laboratories.

USP, Apotex and researchers weigh in on FDA’s draft guidance on biosimilarity

01-Aug-2014 By Zachary Brennan

Scientists from USP (US Pharmacopoeia), Apotex and an advisory board established by Amgen are all weighing in with suggestions and points of further clarity on the latest US FDA draft guidance on biosimilars.

PaxVax acquires typhoid vaccine, Swiss manufacturing facility

29-Jul-2014 By Zachary Brennan

Specialty vaccine company PaxVax has acquired the oral typhoid vaccine Vivotif from Crucell, as well as its manufacturing facility in Thörishaus, Switzerland. Financial terms of the transaction were not disclosed.

Thermo Fisher raises guidance on 'fabulous' biopharma services growth

25-Jul-2014 By Dan Stanton

The biopharma services market keeps expanding and “growth prospects look fabulous,” says Thermo Fisher, reporting better than expected sales across its Life Sciences business for the second quarter 2014.

Profits and capacity utilisation up at Lonza in H1 thanks to pharma

24-Jul-2014 By Gareth Macdonald

Lonza saw profits and capacity utilisation improve in the first half of 2014 with new pharma and biopharma supply contracts and ongoing restructuring being the key drivers.

Biosimilar trials: the ‘under the radar’ sourcing race

23-Jul-2014 By Fiona Barry

Timescales and sourcing comparator biologics are the biggest challenges for biopharmas running biosimilars studies, says an expert.

Pamplona CMO bullish about biopharma prospects after fundraising

22-Jul-2014 By Gareth Macdonald

3P Biopharmaceuticals has raised funds and announced plans to invest in its manufacturing capabilities to meet the needs of international clients.

UPDATE

Sterile injectables M&A could indicate return to in-house production

22-Jul-2014 By Dan Stanton

Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says industry risk aversion is the key driver.

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.

Biopharma Briefs

18-Jul-2014 By Staff Reporter

Latest biopharma news in brief.

Consultant: For CMO selection, its the (molecule) size that counts!

16-Jul-2014 By Dan Stanton

The complex nature of biopharmaceuticals dictates the choice of contract manufacturer when compared with selecting a partner for small molecule drugs, according to a life sciences consultant.

Particle Sciences adds biopharma analysis capabilities ahead of schedule

16-Jul-2014 By Gareth Macdonald

Particle Sciences has beefed up its biopharmaceutical testing capabilities ahead of schedule in response to customer demand.

Shire's Board succumbs to AbbVie's $53bn bid

16-Jul-2014 By Dan Stanton

The acquisition of Shire for £31bn ($53bn) has moved a step closer but reliance on third party suppliers would only add two facilities to AbbVie's biomanufacturing network.