Contract Manufacturing

What links gin, 1960s pop balladeer Donovan and Molecular Profiles?

13-Apr-2015 By Gareth Macdonald

Molecular Profiles has changed its name to Juniper Pharma Services in a move designed to facilitate further expansion in the US.

Aptuit to expand API capacity in UK, Italy due to increasing demand

06-Apr-2015 By Zachary Brennan

Connecticut-based CMO Aptuit opened a 1600L/1000L reactor stream at its API facility in Oxford, UK, and increased throughput at its 400L reactors at its site in Verona, Italy.

WuXi sells small share of CMO subsidiary for $28m

06-Apr-2015 By Zachary Brennan

Chinese service provider WuXi PharmaTech has sold a 5.55% stake in its wholly owned CMO (contract manufacturing organization) subsidiary SynTheAll Pharmaceutical (STA) to members of STA’s and WuXi’s management for $28m.

Alkermes downgraded on concerns about ability to compete in crowded markets

03-Apr-2015 By Gareth Macdonald

Alkermes has been downgraded by analysts who say the success of its decision to focus on own-brand products and sell its legacy CMO site hinges on its ability to win in already competitive markets.

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).

Onyx Scientific expands API facility on Phase I/II demand

01-Apr-2015 By Dan Stanton

A rise in demand for small scale APIs has driven Onyx Scientific to expand its GMP operations in North-East England.

PEOPLE ON THE MOVE

Ex-ICON director joins imaging services company

27-Mar-2015 By Fiona BARRY

Plus people on the move at CROs, genome companies, and medical device contract manufacturers.

Adroit collaboration: Recipharm teams with solid state formulation firm

26-Mar-2015 By Gareth Macdonald

Swedish CMO Recipharm has teamed up with formulations and solid state chemistry firm Adroit Science in a strategic collaboration.

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.

Nanobiotix appoints CordenPharma as CMO for potential nanoparticle-based cancer treatment

19-Mar-2015 By Zachary Brennan

The late clinical-stage nanomedicine company Nanobiotix has selected CordenPharma as its contract manufacturing partner.

ImmunoCellular taps PharmaCell to manufacture dendritic cell-based vaccine for trial

19-Mar-2015 By Zachary Brennan

European CMO PharmaCell B.V. has finalized an agreement with ImmunoCellular Therapeutics to support its pivotal phase III clinical trial in Europe with ICT-107, a dendritic cell-based vaccine in development for glioblastoma multiforme, a form of brain...

Recipharm completes Korean serialisation project for Abbott

18-Mar-2015 By Zachary Brennan

The Korean project, which began in April 2014, required the Sweden-based CDMO (contract development and manufacturing organization) Recipharm to produce a data matrix code, including serial number, to comply with the regulations that are expected to be...

Rise in outsourcing to lead to further CMO consolidation, DPx CEO says

18-Mar-2015 By Zachary Brennan

The CMO (contract manufacturing organization) industry is ripe for consolidation as the rise in outsourcing continues and clients look to simplify their supply chains, DPx CEO James Mullen told Outsourcing-Pharma.com on Wednesday.

Endotoxin and microbial testing to become portable

16-Mar-2015 By Fiona BARRY

Bacterial testing is moving from the lab to the manufacturing floor, says an expert at CRO Charles River.

Update

WuXi to more than double US cell therapy manufacturing ops with new site

12-Mar-2015 By Zachary Brennan

China-based CDMO WuXi PharmaTech unveiled Thursday that it will soon begin construction on its third cell therapy manufacturing facility -- a 145,000-square-foot cGMP facility in Philadelphia.

WHO: Smart needles key to preventing new hep B infections

12-Mar-2015 By Gareth Macdonald

New hepatitis B treatment guidelines advocate use of Gilead and BMS drugs and underline WHO concerns that needle reuse spreads the virus.

PEOPLE ON THE MOVE

On the move in outsourcing: the big job changes

12-Mar-2015 By Fiona BARRY

Ex-FDA expert takes job in bio-industry, plus management changes at CMOs and services companies.

AMRI sets sights on acquiring Indian API manufacturer, CEO says

11-Mar-2015 By Zachary Brennan

Following its three acquisitions over the last year, AMRI is now looking to extend its footprint into India further with the acquisition of a FDA-approved API site, William Marth, president and CEO of AMRI, told attendees at the Barclays Global Healthcare...

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.

Penn invests in pill tech citing industry demand

11-Mar-2015 By Gareth Macdonald

Penn Pharma has added new tablet making technology at its facility in Tredegar, Wales citing drug industry demand for dry granulation manufacturing capacity.

Patheon focuses on solubility with acquisition of Oregon-based CDMO

09-Mar-2015 By Zachary Brennan

For the second time in just over a week, CDMO Patheon has made an acquisition, this time for Agere Pharmaceuticals, a privately held CDMO based in Bend, Oregon, that specializes in improving the bioavailability of drugs.

Wuxi lowers projections for FY 2015 due to CapEx investments, stock takes 10% hit

09-Mar-2015 By Zachary Brennan

Aggressive investment in new manufacturing capacity and new initiatives in genomics and cell therapy in 2015 is forcing CRO Wuxi to lower its expectations for 2015, and the lowered projections also seemed to have caused the company’s stock to fall by...

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...

Patheon: Irix deal about US and Canadian customer demand for local APIs; all staff to be retained

05-Mar-2015 By Gareth Macdonald

Irix Pharmaceuticals will cater for North American customers’ desire for local supply according to Patheon, which says it plans to retain the API firm’s 180 staff.

Patheon has bought hard-to-make API specialist Irix Pharmaceuticals

04-Mar-2015 By Gareth Macdonald

Patheon has bought hard-to-manufacture active pharmaceutical ingredient (API) specialist, Irix Pharmaceuticals.

Valeant sacks Dendreon admin staff and plans manufacturing savings

04-Mar-2015 By Gareth Macdonald

Valeant has started cutting jobs at Provenge manufacturer Dendreon just over a week after it acquired the bankrupt firm for $495m (€444m).

CMO group wants US FDA fees to be exempt from enforced budget cuts

03-Mar-2015 By Gareth Macdonald

A US CMO industry group has backed plans to exempt privately paid user fees from Government spending cuts enforced if US politicians fail to agree a budget.

Sun Pharma goes after opiates with deal to buy GSK’s Aus business

03-Mar-2015 By Fiona BARRY

Indian giant Sun Pharma has bought GSK’s Australian Opiates business.

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.

Japanese companies acquire CMO KBI Biopharma

26-Feb-2015 By Zachary Brennan

Tokyo-based CMIC Holdings Co., Innovation Network Corporation of Japan (INCJ), and JSR have agreed to acquire KBI Biopharma, a contract development and manufacturing organization with facilities in Durham and Research Triangle Park, North Carolina and...

Bayer manufactures for biologics start-up in CoLaborator project

26-Feb-2015 By Fiona BARRY

Bayer has announced a strategic alliance to manufacture a preclinical candidate for small biotech Aronora.

Sagent shifts production in-house after US FDA concerns about CMO Emcure

25-Feb-2015 By Gareth Macdonald

Problems at Emcure Pharmaceutical have prompted US customer Sagent Pharmaceuticals to recall two lots of a muscle relaxant made by the CMO and take production in-house.

Catalent wants to raise $630m through follow on offering

24-Feb-2015 By Gareth Macdonald

Catalent wants to raise $629.3m (EUR550m) through a follow-on offering that will see Blackstone sell 17.6m shares.

Syringe reuse not clever: WHO advocates use of "smart" syringes to stop disease spread

23-Feb-2015 By Gareth Macdonald

‘Smart’ syringes that can’t be reused should be the drug and vaccine delivery technology of choice for healthcare programmes according to the WHO, which says needle reuse is spreading deadly infectious diseases.

Facility already supplying Granules' JV partner Ajinomoto Omnichem with validation batches

Granules predicts US and EMA approval for new API plant in two years

23-Feb-2015 By Gareth Macdonald

An API and intermediates plant set up by Granules India and Ajinomoto Omnichem is a step closer to opening after an offical inauguration ceremony last week.

AstraZeneca R&D arm signs five-year deal with NIST to advance discovery, manufacturing

23-Feb-2015 By Zachary Brennan

MedImmune, the biologics R&D arm of AstraZeneca, and the US National Institute of Standards and Technology (NIST) have signed a five-year agreement to support research that will help advance drug discovery and biomanufacturing.

Novasep signs €4.7m biomanufacturing deal with biotech

18-Feb-2015 By Zachary Brennan

Novasep has signed a €4.7m ($5.4m) agreement with Celladon, a clinical-stage biotechnology company, to prepare to supply the drug substance for the heart failure treatment Mydicar.

WuXi borrows $165m from Asian banks for M&A deals in 2015

18-Feb-2015 By Zachary Brennan

China-based CRO WuXi PharmaTech has entered into a syndicated loan facility to borrow up to $165m from a consortium of banks in Asia to seek out new acquisitions.

Fresenius Kabi sells cancer compounding biz to NewCo Pharma

17-Feb-2015 By Gareth Macdonald

Fresenius Kabi has sold its cancer drug pharmacy network CFL GmbH to NewCo Pharma GmbH five years after spending €42m to buy compounding capacity in Germany.

More US FDA draft guidance for compounders

16-Feb-2015 By Gareth Macdonald

The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.

PE-backed Laurus Labs sets up US drug ingredients business

16-Feb-2015 By Gareth Macdonald

Warburg Pincus-backed HIV drug ingredient firm Laurus Labs has set up a US presence and development facility in a bid to win more North American customers.

Enteris plans to beat established API CMOs on lead times

16-Feb-2015 By Gareth Macdonald

Enteris Biopharma says it can compete with established API CMOs by offering shorter lead times and greater flexibility.

AMRI looks to close API facility in Wales as part of network realignment

12-Feb-2015 By Dan Stanton

AMRI has announced plans to close an API development and manufacturing plant in Wales, UK, after efforts to establish it as a conduit between the US and Europe were deemed unsuccessful.

Ex-Unigene execs who run Enteris add API contracting service to delivery tech licensing business

12-Feb-2015 By Gareth Macdonald

Enteris BioPharma has broadened its business beyond drug delivery tech licensing and launched a contract API manufacturing service.

Unilife upping device production as market opportunity offsets flat sales

10-Feb-2015 By Dan Stanton

Unilife Corporation has ramped up production of delivery devices as pharmas looks to differentiate injectable therapies from the competition.

Penn is mightily pleased with safety record

10-Feb-2015 By Gareth Macdonald

Banishing kettles, 'Gemba walks' and encouraging employees to report near misses have helped Penn Pharma to remain accident free at its high potency compound manufacturing facility in Wales.

Cambrex: ‘Either we invest now or turn away API business”

09-Feb-2015 By Dan Stanton

Ongoing demand for large-scale APIs combined with high capacity utilization has driven Cambrex Corporation to allot up to $85m (€70m) for manufacturing expansion in 2015.

Provenge in a dish not yet sold: Valeant ups Dendreon offer after competing bids

06-Feb-2015 By Gareth Macdonald

Bankrupt cell therapy firm Dendreon has attracted more suitors according to stalking horse bidder Valeant, which upped its offer for the Provenge (sipuleucel-T) developer to $400m this week.

Dispatches from InformEx

What helps an outsourcing partnership? Be up front about the bad news

06-Feb-2015 By Zachary Brennan

When it comes to forging solid relationships between CMOs (contract manufacturing organizations) and drug developers, one thing is clear: deviations will occur.

Water Street targets generic injectables sector with CMO buy

05-Feb-2015 By Gareth Macdonald

Water Street Healthcare Partners has bought US generic injectables contractor Custopharm.

Product Innovations

Generic method approach for determination of residual solvents in active pharmaceutical ingredients by gas chromatography

Solvents are defined as organic chemicals that are used to dissolve components. They are used during the manufacture of drug substances and can also potentially...

Pulmonary Delivery of Orally Inhaled Therapeutics

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Addressing Challenges with Clinical In-Use Testing

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

Outsourcing-Pharma

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