Analytical testing, QC

Hospira Recalls Lots of Five Injections as FDA Re-Inspection Continues

27-Feb-2013 By Zachary Brennan

Hospira has announced it is voluntarily recalling multiple lots of five different injections because of customer reports of faulty packaging and contamination. 

Solvias buys Confarma for EU pharma quality control capacity

04-Feb-2013 By Gareth Macdonald

Solvias has bought quality control services firm Confarma, expanding its analytical offering and adding capacity in several EU markets.

update

Chemi Pharmaceutical cries sabotage after licence suspension

06-Dec-2012 By Gareth Macdonald

Chemi Pharmaceutical CEO says sabotage by former employee behind accusations of falsified test results that prompted Canadian regulators to suspend license. 

SGS and blue inspection body to be excipact trained

29-Nov-2012 By Gareth Macdonald

The group behind the excipient certification scheme Excipact will train SGS and blue inspection body GmbH auditors under agreements signed this week.

NMR culture anlaysis complies with ICH Q2A and B, says Spinnovation

20-Nov-2012

CRO Spinnovation Biologics says its cell culture optimization technique complies with analytical methods detailed in ICH Q2A and Q2B guidelines.

Biotrial to buy Warnex’s remaining biz for $6m; plans US clinical unit

30-Oct-2012

French contract research organisation (CRO) Biotrial will buy Warnex’s bioanalytical services business for C$6m before the end of the year.

Carestream sells preclinical imaging biz to Bruker

24-Sep-2012

Carestream Health has offloaded most of its preclinical molecular imaging systems in a deal with Bruker.

Merck Serono signs master agreement with its new spin-off

10-Sep-2012

Merck Serono has inked a master services agreement with its recently spun-out biomarker analysis services firm Quartz Bio.

Charles River buys Accugenix to boost microbial testing

29-Aug-2012 By Natalie Morrison

Charles River Laboratories has acquired Accugenix in a bid to expand its endotoxin and microbial detection portfolio.

Icon readies itself for translational medicine boom with Manchester expansion

14-Aug-2012 By Natalie Morrison

Icon has boosted its Phase I translational medicine services in Manchester, UK, in preparation for what it believes will be a boom in the drug development area.

EXCLUSIVE

Big Pharma looking to home care to bolster clinical activities: ResearchNurses.co

09-Aug-2012 By Natalie Morrison

ResearchNurses.co will conduct home visits in clinical trials for three Big Pharma firms after forging an agreement with Nottingham University Hospitals Research and Innovation Department.

New pharma services from M&A and partnerships: round-up

07-Aug-2012 By Natalie Morrison

Outsourcing-Pharma.com presents the low down on new services forged by partnerships and M&A (mergers and acquisitions), including a molecular biology offering for Quotient, Onyx’s added purification and separation capabilities, and Accenture’s new...

UPDATE

Covance's flagging early phase biz puts downer on net profits in Q2

26-Jul-2012 By Natalie Morrison

Covance has reported a net loss of $12.7m in this year’s Q2 as what it says is the result of facility closures and restructuring costs, particularly for its early phase development section.

BioFocus gives itself room to update compound library

17-Jul-2012 By Natalie Morrison

BioFocus has taken on Titian’s sample management software in a bid to pump more resources into “refreshing” its 900,000 strong high-throughput screening (HTS) compound portfolio.

News from LabCorp, Quintiles, Synexus and CRI

16-Jul-2012

LabCorp moves closer to expanding central labs biz, Quintiles builds in Brazil, Synexus grows in South Africa and CRI opens new research facility -  Welcome to Outsourcing-pharma.com’s round up of the latest news in the services space.

New foreign body inspection squad for RSSL

05-Jul-2012 By Natalie Morrison

RSSL says its new foreign body inspection team could help get offline factories up and running more quickly following incidents of contamination.

Investments in CMO activities: round up

03-Jul-2012 By Natalie Morrison

Outsourcing-Pharma.com presents a round-up of the latest contract manufacturing investments, including new screening services for Imaxio, Encap’s renewed push for its CMO biz, and Pernix’s bid to take over Great Southern Laboratories.

EPS launches same-day microbial analysis service

02-Jul-2012

Emeryville Pharmaceutical Services (EPS) has launched a new “same day” chemistry and microbiology analysis service.

US base will bridge gap for manufacturing in China, says Suzhou pharma

27-Jun-2012 By Natalie Morrison

China-based Suzhou Pharma has set up a US regulatory and QA hub in what it says is a bid to provide Western cGMP (current good manufacturing practice) know-how with low cost Asian production.

Roowin takes over old Schering-Plough plant, boosts small scale GMP services

26-Jun-2012 By Natalie Morrison

Roowin says it will be one of the first small batch GMP makers for Phase I & II clinical trials after moving into a new facility in Riom, France.

Quotient & Capsugel partner on lipid formulation services

26-Jun-2012 By Natalie Morrison

Quotient and Capsugel have teamed up to tackle drug delivery challenges in lipid-based formulations with new assessment and development services.

Catalent and Bend partner on oral controlled-release development

25-Jun-2012 By Natalie Morrison

Catalent and Bend Research have joined forces to tackle time and cost restrictions for the complex oral controlled-release development and manufacturing process.

BASF rolls out in-house predictive tox testing tech as service

13-Jun-2012 By Gareth Macdonald

German chemicals giant BASF has made its in-house predictive toxicology testing tech available as a suite of services.

SGS opens assay lab in France

13-Jun-2012 By Gareth Macdonald

SGS’ has opened a new cell-based assay laboratory in Poitiers, France in its latest European, biopharma-focused investment.

SAFC pieces together services for fuller chiral offering

13-Jun-2012 By Natalie Morrison

SAFC has coupled its chiral screening and small-scale purification services to meet what it says is a boom in demand for more complete chemical analysis from drugmakers.

Catalent continues to boost biologics offering

06-Jun-2012 By Natalie Morrison

Catalent has upgraded its North Carolina, US, sterile development and analytics plant to increase its aseptic fill-finish activities four-fold in a bid to boost its integrated biologics offering.

Contractor audit failings jump into MHRA top 10 deficiencies

28-May-2012 By Nick Taylor

Failure to properly audit suppliers and contractors jumped into the top 10 MHRA inspection findings last fiscal year.

SGS buys Scottish biotesting firm Vitrology

22-May-2012 By Gareth Macdonald

SGS has bought Scottish contract biosafety testing firm Vitrology with an eye on the biologics services market. 

Evotec and 4-Antibody team up to "revolutionise" early antibody detection

21-May-2012

Evotec and 4-Antibody have teamed up to offer a new antibody testing service.

IGI hires after “notable shift” in pharma services demand

16-May-2012 By Nick Taylor

IGI Laboratories has boosted hiring after its pharmaceutical contract manufacturing unit experienced a “notable shift” in demand.

Know how your CMO will deliver its promises, says Baxter

09-May-2012 By Natalie Morrison

“Understand not only what your CMO can do, but how they can get it done,” was Baxter’s message during a speech at the year’s Interphex in New York.

SGS adds formulation development services and expands US lab

07-May-2012 By Gareth Macdonald

SGS has added formulation development to its service offering through the expansion of its laboratory in Illinois.

Warnex repays debentures, signs financing deal and lists on new exchange

23-Apr-2012 By Gareth Macdonald

Battling contract services firm Warnex has repaid debentures through a new financing deal and will list on the Toronto Stock Exchange’s venture exchange from tomorrow.

Spinnovation launches NMR-based media analysis service

19-Apr-2012 By Gareth Macdonald

CRO Spinnovation Biologics says new media analysis service will help developers answer culture scale-up questions faster and more cheaply than currently available methods.

Catalent eyes emerging market expansion of end-to-end development service model

04-Apr-2012 By Natalie Morrison

Catalent wants to build on its European expansions by replicating the end-to-end drug development services model in emerging markets. 

Warnex delays results and receives debenture default notice

29-Mar-2012

Laboratory services firm Warnex has put back the release of its full year results and received a formal notice of default from the holder of its outstanding debentures.

Advantar Labs moving to new site to build CRO relationships

21-Mar-2012

Advantar Laboratories is moving to a bigger facility in San Diego this week to expand its relationships with CROs.

UPDATE

Horizon adds free technical support services for its genomic editing tech

06-Mar-2012 By Natalie Morrison

Horizon Discovery has launched a new website to provide technical support to researchers using its rAAV-mediated genome editing tech.

Celerion and Ricerca team up with one-stop-shop services for biosimilars

01-Mar-2012 By Natalie Morrison

Celerion and Ricera Biosciences have launched a new joint venture to provide a cost-cutting one-stop-shop solution for companies developing and commercialising biosimilars.

FDA hits lab with warning letter for using one login for all staff

01-Mar-2012 By Nick Taylor

A US contract testing laboratory has received a FDA warning letter for allowing all its employees to use the same username and password.

Warnex pulls out of analytical services divestiture

22-Feb-2012 By Gareth Macdonald

Warnex has pulled out of a C$1.1m (€833,000) deal to sell its analytical services business, alleging that the buyer failed to fulfil its obligations.

Ipsen to take writedown after Lonza warning letter hits supply

02-Feb-2012 By Nick Taylor

Ipsen may take a writedown up to €180m after FDA action against its API CMO, Lonza, created supply uncertainties.

Contract manufacturing round-up

26-Jan-2012 By Natalie Morrison

Outsourcing-Pharma presents a round-up of the latest headlines within the world of contract manufacturing. Catalent and Patheon have each launched oral dosage partnership news, whilst Frontage and AMPAC have received regulatory go-aheads.

Outsourcing still a gamble that needs strategic vision to succeed, says study

24-Jan-2012 By Natalie Morrison

Outsourcing is a gamble for the industry that needs a closer collaborative approach if pharma firms want a successful performance, according to new research.

SGS to open 2nd Indian lab on schedule; 2011 revs grow despite ‘tough’ European market

19-Jan-2012 By Gareth Macdonald

SGS’ new analytical lab in Mumbai, India will open later this week just six months after the analytical services firm began its construction.

Patient derived tumours can take candidate selection to a 'new level', says VivoPharm

18-Jan-2012 By Natalie Morrison

VivoPharm says its new agreement with primary patient-derived tumour creators EPO-GmbH will bring drug candidate selection to a “new level” for US drug researchers.

NSF moves into medical device trial training

18-Jan-2012

Training and consultancy firm NSF Health Sciences (NSF-DBA) has acquired Pink Associates in a bid to broaden its service offering.

Contract manufacturing news round-up

16-Jan-2012 By Natalie Morrison

Outsourcing-Pharma presents a round-up of the latest contract manufacturing headlines in the industry, including news from Nanohale, Fleming and Trophogen.

Warnex will be forced to leave Toronto exchange next month

16-Jan-2012 By Gareth Macdonald

Contract services firm Warnex will leave the Toronto Stock Exchange (TSX) after failing to meet the requirements for continued listing.

Sigma-Aldrich to offer start to finish bio-testing thanks to BioReliance takeover

10-Jan-2012 By Natalie Morrison

Sigma-Aldrich says it is a step closer to becoming a one-stop-shop for biopharmas in the drug discovery process after it inked a takeover agreement with biological testing firm BioReliance.