Contract Manufacturing

Gilead's reliance on CMOs gives firm 'flexibility' says CFO

21-May-2015 By Dan Stanton

Reliance on CMOs and CROs has allowed the flexibility to make Gilead a top 10 pharma firm, and the use of third-parties will remain part of its strategy according to the CFO.

Pharmatek bulks out spray dried dispersion services

20-May-2015 By Dan Stanton

CDMO Pharmatek has expanded its bioavailability services on the back of client demands, installing new spray dried dispersion equipment.

Two sterile compounders hit by FDA warning letters for violating cGMP

20-May-2015 By Dan Stanton

The US FDA has lambasted two sterile compounders for violating cGMP in letters citing recent legislation brought in to ensure such companies are fully regulated.

Cancer-hunting shark proteins are the future of drug conjugation, says Almac

19-May-2015 By Fiona BARRY

Almac is coupling tiny shark proteins to a cancer-killing warhead to develop an oncology drug, saying their small size makes for easy conjugation. 

European freeze-drying market heats up: Symbiosis invests citing high demand

19-May-2015 By Gareth Macdonald

Symbiosis Pharmaceutical Services has launched a bulk freeze drying offering for APIs and intermediates, citing new contracts as a driver for the investment.

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.

Tigermed Envy? WuXi may be eyeing a launch on Shenzhen exchange

14-May-2015 By Zachary Brennan

With WuXi pushing full steam ahead in its bid to go private, one expert says that the company may be envious of a competing CRO -- Hangzhou Tigermed, which is smaller than WuXi but valued at a higher price on the Shenzhen stock exchange.

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.

PEOPLE ON THE MOVE

Outsourcing jobs: people on the move in pharma

13-May-2015 By Fiona BARRY

Outsourcing-Pharma.com's weekly round-up of job changes at CROs and diagnostics companies.

Perrigo enters softgel space buying ex-Banner operations for $34m from Patheon

13-May-2015 By Dan Stanton

Patheon has sold its Mexican operations to Perrigo for $34m as it looks to transform the Banner business it acquired back in 2012.

Lonza to help Nikon set up a contract cell and gene therapy manufacturing business in Japan

08-May-2015 By Zachary Brennan

Under the partnership, Nikon will have access to Lonza’s quality and operating systems, facility design and ongoing consulting services for the establishment of a wholly-owned Nikon cell and gene therapy contract manufacturing business. 

Registering as an outsourcing facility helps rid compounding safety stigma, Fagron

07-May-2015 By Dan Stanton

Compounding pharmacies must show they can produce high-quality medicines in order to overcome their safety stigma, according to Fagron which is opening a sterile facility in Kansas.

AMRI riding high on API acquisitions, expects more M&A to come

06-May-2015 By Dan Stanton

AMRI attributed a robust first quarter to its growing API business and recent acquisitions, and says to expect more M&A activity this year.

API firms stand to gain by seeking prequalification says the WHO

05-May-2015 By Gareth Macdonald

Persuading API manufacturers to seek prequalification is a challenge according to the WHO, which wants to raise awarness about the process and the positive impact it has on a suppliers' reputation.

Alkermes: Sale of 'non-core' CMO unit supports blossoming portfolio

04-May-2015 By Dan Stanton

Alkermes will continue to streamline its manufacturing and infrastructure to support a growing portfolio following the sale of its legacy CMO site.

WuXi begins construction on $150m disposable biomanufacturing site in China

04-May-2015 By Zachary Brennan

WuXi PharmaTech subsidiary WuXi Biologics has begun construction on a new $150m biologics manufacturing facility in Wuxi, China, which is expected to be the largest mammalian cell culture manufacturing sire using disposable bioreactors in the world.

Charles River stock falls nearly 10% on soft quarterly results

30-Apr-2015 By Zachary Brennan

Charles River Laboratories saw only slight growth in revenue compared to the same quarter last year, which was driven by its safety assessment and endotoxin and microbial detection businesses, and double-digit revenue increases from mid-tier biotech clients.

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.

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

MHRA licence to allow CDMO Juniper to manufacture 'Specials'

23-Apr-2015 By Dan Stanton

Juniper has received a licence to make unlicensed medicinal products – or ‘Specials’ – but will only produce batches with relatively high volumes to keep clients’ costs down.

Recipharm in talks to make LIDDS' prostate cancer drug-device candidate

22-Apr-2015 By Dan Stanton

Recipharm has begun negotiations to manufacture a prostate cancer drug-device candidate for Swedish pharma firm LIDDS.

Genentech makes cell line identification faster and cheaper

22-Apr-2015 By Anthony King

Genentech scientists have created a faster, cheaper way to identify cell lines, a boon for CMOs and preclinical researchers. 

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.

Catalent completes expansion of US complex tablet site

16-Apr-2015 By Gareth Macdonald

Catalent has doubled production capacity and added extra analytical lab space at its facility in Winchester, Kentucky, US.

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.

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.