Contract Manufacturing

Xcelience invests in CMO Powdersize

03-Aug-2015

CDMO (contract development and manufacturing organization) Xcelience has made a structured cash investment in Pennsylvania-based Powdersize, which specializes in milling, micronization and powder size classification.  

LabCorp’s Covance expands clinical research unit in Texas

28-Jul-2015 By Zachary Brennan

LabCorp’s Covance Drug Development has relocated its clinical research unit (CRU) in Dallas, TX, to a new facility with 28 more medical beds. 

Biologic services demand pushes BioOutsource to open new Glasgow facility

28-Jul-2015 By Zachary Brennan

A surge of demand in biologics contract testing and biosimilar characterization has caused BioOutsource to double its capacity with the opening of a new facility in Glasgow, Scotland.

AMRI's business risk profile 'weak,' says S&P

27-Jul-2015 By Dan Stanton

A Standards & Poor analyst has rated contract development and manufacturer AMRI as ‘stable,’ but says it lacks the scale and breadth of offerings of its competitors in the CDMO industry.

Patheon sells chemicals sites to focus on pharma ahead of IPO

24-Jul-2015 By Gareth Macdonald

Patheon has sold a production plant in Italy to LIVIA and agreed to a management buyout at a site in Austria as it prepares to go public.

Capsugel expanding Encap plant on rising HPAPI demand

23-Jul-2015 By Dan Stanton

Capsugel is doubling the size of a facility in Scotland to support demand for the encapsulating of drugs containing high-potency active pharmaceutical ingredients (HPAPIs).

Chicago CMO opens potent small molecule site

23-Jul-2015 By Fiona BARRY

Contract manufacturing organisation Regis Technologies has added an HPAPI (highly potent active pharmaceutical ingredient) service.

Lonza: global hedge helped offset currency exposure but Visp still a risk

22-Jul-2015 By Gareth Macdonald

Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.

West scaling up AZ plant on demand for Smartdose wearable injector

21-Jul-2015 By Dan Stanton

Demand for West’s wearable injector - which uses the recently-approved Crystal Zenith delivery system - has led to the expansion of a facility in Arizona.

Gadea's steroid intermediates biz means AMRI not reliant on Asian suppliers say execs

20-Jul-2015 By Gareth Macdonald

AMRI has bought Spanish contractor Gadea Pharmaceutical Group for $174m (€160m) to add muscle to its steroid API business and sign up more customers outside the US.

Biocon: IPO will evolve Syngene CRO into full manufacturing services firm

20-Jul-2015 By Dan Stanton

Indian CRO Syngene has received approval for its IPO prospectus paving the way to spin out from its parent company Biocon.

Green GMP criteria would help responsible API firms compete with polluters says DSM Sinochem

20-Jul-2015 By Gareth Macdonald

API firms that invest in waste management find it hard to compete with those that pollute according to DSM Sinochem, which wants environmental criteria included in GMP standards for environmental and business reasons.

Perfusion and chromatography beat ALS cell therapy production challenges, says Goodwin

17-Jul-2015 By Dan Stanton

Goodwin Biotechnology says making trial supplies of Q Therapeutics’ amyotrophic lateral sclerosis (ALS) cell therapy meant overcoming considerable technical hurdles.

Eisai to transfer RTP manufacturing campus to Biogen, plans 35 layoffs

17-Jul-2015 By Zachary Brennan

Eisai has agreed to transfer ownership of its Research Triangle Park (RTP) manufacturing campus to Biogen, which will continue to manufacture oral solid-dose products and parenteral products at the sites for Eisai.

Peregrine flying high as CMO biz preps to open new mAb facility

16-Jul-2015 By Dan Stanton

Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine, which is hoping to commercialise its breast cancer candidate.

Proteon extends vonapanitase manufacturing deal with Lonza

16-Jul-2015 By Dan Stanton

Proteon Therapeutics has extended a deal with Lonza for the development and manufacture of its lead product, the pancreatic elastase candidate vonapanitase.

WuXi to create $200m investment fund following initial success

15-Jul-2015 By Zachary Brennan

The almost-private China-based CDMO (contract development and manufacturing organization) WuXi is looking to reap larger rewards from investing in US and China pharma and biotech firms.

Aptuit expands to bring on later-stage capabilities following client demand

14-Jul-2015 By Zachary Brennan

CDMO (contract development and manufacturing organization) Aptuit is investing in additional scale and capabilities at its Italian site to augment its 1600L scale API capability and to add a commercial GMP license. 

Environmental group welcomes DSM-Sinochem and GSK efforts to halt spread of antibiotic resistance

13-Jul-2015 By Gareth Macdonald

Antibiotic API makers have an obligation to ensure their activities do not spread resistance says a group that welcomed DSM-Sinochem’s commitment to environmentally-friendly production.

UCB: automation makes supplier and vendor management 20% more efficient

13-Jul-2015 By Gareth Macdonald

UCB claims automating supplier management with the help of Genpact generated cost and time efficiencies at operations worldwide.

Catalent hit with FDA Form 483 at North Carolina plant

13-Jul-2015 By Zachary Brennan

Following an FDA inspection in March, Catalent’s Center of Excellence for Analytical Services in Morrisville, NC was hit with a Form 483 with six observations.

Heating issues caused death of 39 Guinea pigs at JHP Pharma facility

10-Jul-2015 By Dan Stanton

Par Pharmaceuticals says it has addressed its temperature-control system at a Michigan facility after overheating caused the death of 39 guinea pigs.

CDMO roundup: DPT rejig, UDG expansion and Dalton contract

10-Jul-2015 By Dan Stanton

An operational rejig at DPT Laboratories, an expansion at UDG, and a synthesis and toxicology testing contract win for Dalton – welcome to Outsourcing-Pharma’s CDMO round-up.

US court’s decision highlights risk of using a CMO prior to filing a patent application

08-Jul-2015 By Zachary Brennan

While pharma and biotech companies are increasingly turning to CMO (contract manufacturing organization) partners earlier in the drug development process, they may want to reconsider engaging with a CMO prior to filing a patent after a recent ruling from...

Report: Outsourcing becoming more mainstream in biomanufacturing industry

08-Jul-2015 By Zachary Brennan

As biopharmaceutical companies look to cut costs and understand their core competencies further, the use of outsourcing and off-shoring have become even more mainstream than in years past, according to the 12th annual biomanufacturing report from BioPlan...

ReNeuron to automate stem cell stroke therapy production for Phase III trial

07-Jul-2015 By Gareth Macdonald

ReNeuron will automate processing of its stem cell-based stroke therapy ahead of planned Phase III trials using a system acquired from Sartorius Stedim Biotech (SSB) subsidiary, TAP Biosystems.

GSK back in China via new API manufacturing agreement with Desano

06-Jul-2015 By Zachary Brennan

GSK’s HIV unit ViiV Healthcare and China-based Desano Pharmaceuticals have forged an agreement whereby Desano will manufacture the API of GSK’s HIV drug Tivicay (dolutegravir) in China.

Lonza to set up dedicated manufacturing suite for Alexion

02-Jul-2015 By Gareth Macdonald

Lonza will set up a dedicated manufacturing suite for Alexion, producer of the world’s most expensive drug Soliris.

US FDA accepts IND for TxCell's Crohn's cell therapy; Firm eyes European CRO for US trial

30-Jun-2015 By Gareth Macdonald

TxCell is set to expand a trial of its candidate Crohn’s disease cell therapy to the US after the FDA accepted its IND application.

TxCell to enhance operator training and sterilisation measures at cell therapy pilot plant

26-Jun-2015 By Gareth Macdonald

TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.

IDT Biologika acquires Aeras’ vaccine manufacturing facility

24-Jun-2015 By Zachary Brennan

Vaccine developer Aeras and CMO (contract manufacturing organization) IDT Biologika have formed a strategic partnership that includes the acquisition of Aeras's Biopharmaceutical Development Center (BDC) manufacturing facility by IDT. 

apceth expands gene, cell therapy manufacturing business

23-Jun-2015 By Zachary Brennan

German-based contract manufacturer apceth has received regulatory approval to use two new GMP cleanrooms for aseptic processing, which will be used for the handling and genetic manipulation of various types of cell and gene therapies. 

New nanotech excipient makes for better delayed-release drugs say researchers

22-Jun-2015 By Gareth Macdonald

Swedish scientists who developed the solubility enhancing nanotech excipient Upsalite say it can also be used to improve delayed release formulations.

ScinoPharm to make API for Chinese drugmaker eyeing US celecoxib market

22-Jun-2015 By Gareth Macdonald

Raffles PharmaTech has contracted ScinoPharm to make the API for a generic version of the arthritis pain drug celecoxib being developed for the US market.

BIO 2015

Wuxi and University of Pennsylvania partner on vector production

18-Jun-2015 By Fiona BARRY

Contract research organisation WuXi has entered a manufacturing collaboration with the University of Pennsylvania to produce gene therapy vectors.

Lonza to build viral therapy plant in Texas

17-Jun-2015 By Gareth Macdonald

Lonza will build a viral therapy production site in Houston, Texas in a bid to capture a share of the growing gene therapy market.

Slovenian regulators slam Polydrug API plant in India

17-Jun-2015 By Gareth Macdonald

Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.

BIO 2015

Ex-Homeland Security cyber chief warns of threats to pharma

17-Jun-2015 By Fiona BARRY

The pharma industry must fight “vendor indifference” so suppliers and services companies are not prey to cyber attacks that can lose drug companies hundreds of thousands of dollars in minutes, according to US Homeland Security’s former head of cybercrimes...

US FDA upgrades Jubilant's troubled Washington plant to VAI

12-Jun-2015 By Dan Stanton

A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.

Sterile CMO round-up: news from Vetter, Dalton and LSNE

11-Jun-2015 By Dan Stanton

An expansion at Vetter, a contract win for Dalton and a pre-approval inspection at LSNE – welcome to Outsourcing-Pharma’s round-up of sterile manufacturing news.

Charles River raises questions about its own supply chain

11-Jun-2015 By Zachary Brennan

Minerals used to manufacture two of Charles River Laboratories’ products may be derived from questionable sources in Africa, though following a review of suppliers, the company has yet to fully understand where exactly they’re coming from, according to...

Goodwin to manufacture ADC for Aspyrian

10-Jun-2015 By Zachary Brennan

Aspyrian Therapeutics has selected CDMO Goodwin Biotechnology to complete process development, scale-up, and cGMP manufacturing of their novel antibody drug conjugate (ADC).  

Patheon looks to go public with $100m IPO

09-Jun-2015 By Zachary Brennan

US-based contract development and manufacturing organization (CDMO) Patheon has registered with the SEC as part of plans to go public with an IPO that could be worth as much as $100m.

Accuratus growing CDMO biz through Array Biopharma's CMC operations

09-Jun-2015 By Dan Stanton

Accuratus Lab Services has bought the chemistry, manufacturing and controls (CMC) operations of Array BioPharma to boost its CDMO offering.

Charles River seeing more strategic relationships, CEO says

03-Jun-2015 By Zachary Brennan

As Big Pharma and biotech companies continue to outsource more of their work, one of the leaders in the preclinical and discovery space – Charles River Laboratories – is seeing more strategic relationships with both large and small clients, CEO James...

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.

PE group Water Street sets up contract pharma services unit aimed at generic drugmakers

01-Jun-2015 By Gareth Macdonald

Water Street Healthcare Partners has set up a contract services firm to make products for an unnamed generic drugmaker.

$100m API investment a boost to Gilead's in-house capacity

28-May-2015 By Dan Stanton

Sovaldi maker Gilead Sciences has opened a new laboratory and is investing a further $100m (€91m) for API manufacturing at its site in Canada.

Akron, Cognate partner to offer more complete manufacturing services for gene therapies

28-May-2015 By Zachary Brennan

The strategic partnership between Baltimore-based CMO Cognate BioServices and Florida-based Akron Biotechnology will offer clients a more complete package of cGMP manufacturing services and regulatory support to develop regenerative medicines and cell-based...

Catalent and Lonza's Imbruvica contracts safe says AbbVie, post $21bn acq

27-May-2015 By Dan Stanton

AbbVie has closed the acquisition of Pharmacyclics and confirms it will continue to outsource manufacture the oncology drug Imbruvica.