Breaking News on Pharmaceutical Technology

Bio-Rad takes the stress out of protein purification

Bio-Rad has published several application notes describing the use of its Profinity eXact protein expression system to obtain tag-free native proteins from a cell lysate in less than an hour.

Syrris to tailor-make reactor systems

In response to high customer demand, leading automated chemistry systems manufacturer Syrris is now offering to build custom-made laboratory reactor systems designed to meet individual customer needs.

Draper to establish bioMEMS development centre

US R&D organisation Draper Laboratory has unveiled plans to set up a new centre to develop and produce of its bioMEMS technology for therapeutic and healthcare applications.

Future of Lilly's Lafayette API facility in doubt

The future of Eli Lilly's API manufacturing facility in Lafayette, Indiana has been thrown into doubt by the news the company is considering selling it.

Expectorant seizure easy to swallow for KV

FDA officials have impounded nearly $24m (€15.4m) worth of guaifenesin-containing timed-release (TR) cough and cold medicines made by US specialty drugmaker KV Pharmaceuticals.

Ranbaxy expects probe to be dropped soon

Ranbaxy’s CEO has confidently asserted that the US Food and Drug Administration’s (FDA) court action will be dropped in the near future and fired another warning shot at the “negative elements” he believes were behind the controversy.

Drug delivery news in brief

in-PharmaTechnologist’s periodic round up of developments in the field of drug delivery includes BioDelivery initiating Phase I studies, success for Titan and a novel use for Viagra.

Vyteris’ transdermal peptide delivery completes Phase I

Vyteris has successfully completed a Phase I dose ranging study for its Smart Patch transdermal system for delivery of a peptide hormone.

EMEA clears Viracept contamination of health risk

Patients who took Roche’s antiviral Viracept (nelfinavir) from batches contaminated with ethyl mesilate do not have an increased risk of developing cancer, according to the EMEA.

Lotus' plant sows seeds for growth

Lotus Pharmaceuticals' plans for a RNM 160m ($23.4m) manufacturing facility in Inner Mongolia mark another milestone in the Chinese firm's expansion on the global drugmaking stage.

Lotus' plant sows seeds for growth

Lotus Pharmaceuticals' plans for a RNM 160m ($23.4m) manufacturing facility in Inner Mongolia mark another milestone in the Chinese firm's expansion on the global drugmaking stage.

Weekly comment

Roche faces obstacles in acquiring Genentech

Roche’s proposed $44bn acquisition of Genentech is facing some opposition with Wall Street saying the offer undervalues the company, disquiet among the biotech’s employees and shareholders suing the Swiss giant.

Manufacturing facility news in brief

in-PharmaTechnologist.com's round-up of developments in the pharmaceutical manufacturing space features news of a fire at MY Healthcare, Helsinn's FDA approval and a safety award for Wyeth.

Symyx’ Powdernium helps cut manufacturing costs

R&D integration specialist Symyx Technologies says its Powdernium Workstation is integral to the new automated dry powder dispensing system developed by a "major" but as yet unidentified pharmaceutical company.

GSK continues shift in strategic direction

The pace of change at GlaxoSmithKline (GSK) is showing no sign of slowing, with new CEO Andrew Witty unveiling the company’s new strategic direction with the release of second quarter results.

FDA relaxes GMP rules for Ph I candidates

The US Food and Drug Administration (FDA) has relaxed the regulatory good manufacturing practice (GMP) rules for drugs in early-stage clinical trials in recognition of the different requirements of trial scale and industrial scale manufacture.

Proboscis-mimicking microneedle for drug delivery

Researchers from India and Japan claim to have developed a compact medical device capable of painlessly monitoring a patients insulin levels and administering the required dose.

West African conference to eradicate counterfeits

West African states are meeting to devise a plan for cleaning up their tarnished reputations with regards to the flow of counterfeit pharmaceuticals in the region.

Small molecules drive Lonza contract unit in 1H

Lonza of Switzerland is reaping the benefit of a shift away from bulk chemicals and towards custom manufacturing of high-value pharmaceuticals with a 13 per cent hike in sales in the first half of the year.

Midas & Capsulution cooperate on technology

Midas Pharma and Capsulution NanoScience have entered into a long-term cooperation agreement, with contract manufacturing capacity and other services being provided in exchange for access to drug delivery technology.

Pharma manufacturing products: news in brief

Millipore, Purfresh and ESS Technologies have all recently launched products used in the pharmaceutical manufacturing industry.

Tobacco - cancers cause or cure?

In an ironic twist, researchers have shown that the tobacco plant, the cause of millions of cases of cancer, can be harnessed to produce personalised cancer vaccines.

$300m shot in the arm for Merck’s vaccines plant

US drug giant Merck & Co hopes that an additional $300m (€190m) investment in its vaccine manufacturing plant in Durham, North Carolina will cement its position at the forefront of the global vaccines market

ESA’s CAD improves detection of API impurities

UK-headquartered ESA Biosciences has unveiled a new technique for the identification of low levels organic impurities during the production of active pharmaceutical ingredients (API).

Digitek, heparin and the likelihood of lawsuit success

The heat is being turned up on Actavis Totowa as Federal lawsuits begin to pile up following the Digitek (digoxin) recall.

MeadWestvaco and Bilcare jointly buy packaging firm

Contract packaging company International Labs has been taken over in a joint acquisition between India’s Bilcare and MeadWestvaco of the US.

Overseas customers boost China Bottles contracts

Plastic packaging specialist China Bottles (CB) says that nearly two thirds of the $3.3m worth of contracts it signed in June were with pharmaceutical companies based outside its home territory.

RNAi therapeutics market hots up

Novartis’ extension of its collaboration with Alnylam Therapeutics and Roche’s acquisition of gene silencing specialist Mirus Bio Corp for $125m (€78.5m) suggest that big pharma is beginning to recognize the commercial potential of RNAi-based therapeutics.

Contract manufacturing news in brief

CMC ICOS, PharmEng, HollisterStier and RxElite are among the contract manufacturing organisations (CMOs) with news updates over the last few days.

MeadWestvaco and Bilcare jointly buy packaging firm

Contract packaging company International Labs has been taken over in a joint acquisition between India's Bilcare and MeadWestvaco of the US.

Brookwood acquisition expands delivery portfolio

Brookwood Pharmaceuticals, a subsidiary of SurModics, has acquired the exclusive rights to all pharmaceutical applications of PharmaSol’s nanostructured lipid carrier (NLC) technology.

Four years in prison for counterfeiter

A man has been sentenced in the US to four years imprisonment for trafficking 38,000 counterfeit Viagra (sildenafil citrate) tablets with a wholesale value of $400,000.

FDA reviewers and inspectors to forge closer links

The US Food and Administration says that a new project examining the interaction between its review and facilities inspection arms will help improve inter-departmental communication, particularly during pre-approval inspections (PAI)

Teva pounces on Barr with $7.5bn offer

There looks set to be further consolidation in the generics sector with Teva offering to acquire Barr Pharmaceuticals in a deal worth $7.5bn

Conformia helps ICH QbD implementation

US software company Conformia hopes that its new web-based drug development suite will help pharmaceutical firms meet with new quality by design (QbD) and risk management guidelines.

Eastman launches controlled-release excipient

A new excipient could help drugmakers improve the delivery profiles of active pharmaceutical ingredients (API), according to US developer Eastman Chemical.

3M gets under the skin of drug delivery

3M Drug Delivery Systems believes it has made an advance in the administration of high potency therapeutics through the skin using its solid microstructured transdermal system (sMTS).

Upfront discusses MAb capture systems

With last month's launch of the Rhobust antibody capture system for MAb production applications, Upfront hopes to bring about a seismic shift in the MAb development paradigm.

United makes Sharp deal to boost stateside presence

United Drug of Ireland said yesterday that it had signed a deal to acquire Sharp Corp, a contract pharmaceutical packager based in the US, for $99m.

Ranbaxy claims big pharma company behind falsification accusations

Ranbaxy has claimed that a pharmaceutical company is making a concerted effort to depress the company's share price by initiating the accusations that the generics manufacturer falsified data to achieve compliance.

AccuSpray helps drugmakers cut tablet making costs

The new AccuSpray spray gun can reduce the amount of magnesium stearate that pharmaceutical firms require during drug manufacture, according to developer Oystar Manesty.

CTP is "best-of-breed" for enhancing protein longevity

Modigene says that data from a trial of a Schering-Plough's (SP) fertility stimulation hormone (FSH-CTP) confirms that carboxyl terminal peptide (CTP) modification can extend the therapeutic duration of protein drugs.

Gerresheimer reports 13% sales growth in Q2

German packaging giant Gerresheimer says that higher sales in both its plastics and tubular glass divisions helped boost its performance in the second quarter of 2008.

Manufacturing facility news in brief

in-PharmaTechnologist.com's round-up of developments in the pharmaceutical manufacturing space features news of Interlink's new Irish lab, Rentschler's biotechnology investment and GSK's plan to wind up operations at its Crawley plant.

Weekly comment

FDA evolves application process

The US Food and Drug Administration (FDA) is continuing to evolve in the face of current challenges through the launch of two new initiatives.

FDA launches QbD pilot programme

The US Food and Drug Administration (FDA) is launching a quality-by-design (QbD) pilot programme for biotechnology submissions.

Lonza to co-develop Novartis biologics

Lonza is to co-develop and manufacture Novartis' biological pipeline as part of a long term strategic partnership that has been struck between the companies.

Vitro opens new stem-cell manufacturing facility

Vitro Diagnostics has opened a new facility for the development and manufacture of stem cell products for commercial application in the pharmaceutical industry.

BMS praised for addressing Clean Air violations

Bristol-Myers Squibb (BMS) has agreed to carry out a $3.7m upgrade of production facilities that are in breach of US Clean Air legislation (CAL), according to an Environmental Protection Agency (EPA) statement.

Roche licenses zinc finger tech to aid its discovery programmes

Sangamo Biosciences and Sigma-Aldrich have licensed their zinc finger nuclease (ZFN) technology to Roche to enable the pharma giant to develop cell lines and transgenic animals.

Contract manufacturing news in brief

in-PharmaTechnologist.com's periodic round-up of developments in the world of contact manufacturing includes a plant approval for PharmEng and new contracts for Akorn.

Intranasal pandemic flu vaccine enters clinic

Avir Green Hills Biotechnology's intranasal vaccine deltaFLU for the treatment of pandemic influenza is commencing Phase I clinical trials.

Defeng opts for Praxair cooling technology

Praxair China has won the contract to supply the liquid nitrogen and cooling system for Jiangsu Defeng Pharmaceutical & Chemical's manufacturing plant.

MMBG attractive for drug delivery

Japanese researchers have created a magnetic and mesoporous bioactive glass (MMBG), which combines a flexible drug loading mechanism with user targeted delivery.

Start-ups shot down as credit crunches

The credit crunch is putting the squeeze on start-ups and established companies alike, with numerous firms struggling to obtain the financing that is their lifeblood.

Ark opens Finnish gene-medicine factory

Ark Therapeutics has bucked the trend towards outsourcing that currently dominates the drug industry with the establishment of its new €12.2m ($19.1m) commercial-scale production facility.

Inovio/VGX merger to expedite DNA vaccine development

Electroporation specialist Inovio Biomedical Corp and vaccine developer VGX Pharmaceuticals believe that their recently announced merger will create a firm capable of rapidly moving DNA vaccine candidates from the laboratory to the clinic.

GSK divests drugs to simplify manufacturing operations

GlaxoSmithKline (GSK) has sold four of its off-patent drug products to a South African drugmaker for £170m ($336m), describing the move as part of an ongoing effort to simplify its manufacturing operations.

Ph. Eur. to revise monographs for genotoxic impurities

The new guidelines for how monographs will be revised and elaborated to tackle potentially genotoxic impurities (PGIs) have been published by the European Pharmacopeia Commission.

BioVectra helps Kane ramp up DispersinB manufacture

A new Master Cell Bank (MCB) capable of producing pure cell culture for the manufacture of the anti-biofilm enzyme DispersinB represents a significant breakthrough, according to developer Kane Biotech.

Althea and Protein'eXpert pool resources

US firm Althea Technologies and Protein'eXpert have teamed up to provide a broad array of biomanufacturing services, from protein engineering right through to commercial-scale production.

Polish bureaucracy holding back clinical growth

Poland urgently needs to take some of the red tape out of clinical trial applications if it is to fulfil its potential as a hub for clinical research, according to new market research.

Pfizer's plan to sell Little Island API plant falters

A deal to sell Pfizer's active pharmaceutical ingredient manufacturing (API) plant in County Cork, Ireland, has fallen through according to a statement by the US drug giant, placing over 180 production jobs under threat.

Drug delivery development news in brief

in-PharmaTechnologist's round-up of developments in the field of drug delivery, this week includes a report into protein delivery devices, a new insulin pump and a joint venture to improve block copolymers.

Senesco inks deals for Factor 5A

Senesco Technologies has signed a contract manufacturing deal for plasmids and a licensing agreement for a drug delivery technology as it seeks to get its Factor 5A treatment into clinical trials.

GMP reprieve for Vietnamese facilities

Pharmaceutical manufacturers in Vietnam have gained a reprieve after the Ministry of Health (MoH) informed them that those without good manufacturing practice (GMP) certificates can continue production for now.

CytoDyn starts candidate HIV MAb production

New Mexico-headquartered drugmaker CytoDyn has begun the good manufacturing practice (GMP) standard production of the developmental candidate anti-HIV monoclonal antibody Cytolin (lymphocyte function-associated antigen-1).

Researchers improve siRNA delivery

The delivery of siRNA into cells has taken a step forward according to research published in the Journal of the American Chemical Society.

Pharmaceutical facility news in brief

in-PharmaTechnologist.com's periodic round-up of developments in the field of pharmaceutical facilities includes news of two environmental fines, MHRA plant approval and a strike at Teva.

Sinclair and Wockhardt strike deal

UK-based Sinclair Pharmaceuticals has entered into a manufacturing and distribution agreement with Wockhardt, an Indian pharmaceutical and biotech company.

ProGen launches PharmaSynth manufacturing unit

Biotechnology firm ProGen Pharmaceuticals has spun-out its manufacturing operations as the new wholly-owned subsidiary PharmaSynth.

Patheon to offer cytotoxic services through BSP deal

Contract research and production specialist Patheon is to promote BSP Pharmaceuticals' cytotoxic development and manufacturing services as part of a marketing agreement that the two firms have signed.

Vivalis files BMF for EB66 cell line

Vivalis has filed the biologics master file (BMF) with the US Food and Drug Administration for its EB66 vaccine and therapeutic protein production technology.

AMDL to buy Chinese distributor

Jade Pharmaceutical, a subsidiary of Californian drug firm AMDL, is to acquire privately-held China-based distribution specialist Sichuan ZhiTong Pharmaceutical (SZP).

Liposomal delivery boosts CF drug efficacy in study

Californian pharmaceutical firm Aradigm has unveiled positive safety and efficacy data from an open-label study of its once daily inhaled liposomal antibiotic ciprofloxacin in patients with cystic fibrosis (CF).

Manufacturing technology news in brief

in-PharmaTechnologist.com's periodic round-up of developments in pharmaceutical manufacturing equipment includes Mesa's real time monitoring, cleaning products and Beijer's new operating panel.

Investors not charmed by Cobra's results

Cobra Biomanufacturing has had a disappointing first six months of 2008, reporting an operating loss of $4.8m.

Lonza scores stem cell deal; builds facility

Lonza has scored a contract manufacturing agreement from Osiris Therapeutics for its investigational adult stem cell therapy is building a new facility to support future business activities in this area.

CFC-free metering valves boost Valois 2007 income 28 per cent

Industrial spray and aerosol manufacturer Valois says that strong performance in its pharmaceutical division helped it off-set a hike in raw materials costs and have a successful 2007.

Pharmaceutical manufacturing: people on the move

in-PharmaTechnologist.com presents its periodic round-up of personnel changes in the pharmaceutical manufacturing sector.

Imtech signs contracts worth 40m EUROs with Belgian drug sector

European technical services and industrial engineering specialist Imtech says it has received orders worth around €40m ($64m) from the Belgian operations of firms such as Janssen Pharmaceutica, GlaxoSmithKline (GSK) and Schering Plough.