Breaking News on Global Pharmaceutical Technology & Manufacturing

FDA takes GMP action against US & Chinese drugmakers

The US FDA has filed a permanent injunction against a US drugmaker and sent a warning letter to a Chinese API producer following cGMP problems.

Intercell hopeful for future of needle-free vaccine

Intercell is seeking new partnerships for its struggling needle-free patch system for delivering vaccines.

News in brief

AstraZeneca takes its bioinformatics capabilities to Russia

AstraZeneca is will build a center for bioinformatics and predictive medicine in St.Petersburg, Russia by the end of 2011.

UPDATE

Sanofi still suffering fall-out from Genzyme supply chain disruption

The fall-out from Genzyme’s supply disruptions is still hindering Sanofi, more than five months after taking over the business.

Lonza inks stem cell production pact with Mesoblast

Lonza may build a stem cell production facility dedicated to manufacturing Mesoblast products after inking an alliance.

News in brief

United Drug looking for M&A as packaging demand grows

Contract generics packaging demand and possible acquisitions of up to €300m ($408m) will drive growth at United Drug, an analyst reports.

Unigene cuts SDBG to focus gaze on peptides

Peptide-based therapeutics specialists Unigene will focus on high valuation drug development and drug delivery opportunities after cutting loose its Site Directed Bone Growth (SDBG) patent portfolio.

Altermune Technologies says it will win back "much needed" resistant pathogens investors

Big pharma companies looking to invest in 'superbug' R&D could soon see a better return through Altermune Technologies' new platform.

CMLE OKed to start commercial API production at Netherlands plant

Cambridge Major Laboratories Europe (CMLE) is set to start commercial API manufacturing at its facility in the Netherlands after approval by Dutch regulators.

Ukraine votes to criminalise drug counterfeiting

Ukraine's parliament, the Verkhovna Rada, has voted unanimously in favour of new legislation which will criminalise the production and trafficking of counterfeit drugs.

ProMetic supplying adsorbent to Chinese biosimilar biz

ProMetic Life Sciences is supplying an affinity adsorbent to a Chinese biopharm for use in scale-up of a biosimilar.

News in brief

MannKind raising funds for manufacturing & trials

MannKind is looking to raise $370m (€270m) to fund completion of its manufacturing facility and Phase III trials of its inhaled insulin.

Crystallisation modelling can improve scale up, PSE says

Process Systems Enterprise (PSE) has developed crystallisation modelling software to improve throughput and simplify scale-up.

People on the move: pharma jobs

in-PharmaTechnologist presents its round-up of the new appointments within the pharma biz, including news from Aduro, Catalent, and Eleven.

PerkinElmer's new service aims to speed up instrumentation qualification

PerkinElmer has launched its new Universal Operational Qualification (UOQ) service for pharmaceutical labs.

People on the move: pharma jobs

in-PharmaTechnologist presents its round-up of the latest appointments in the pharmaceutical industry, including news from Silence Therapeutics, InSite Vision, and Zafgen.

UK drug re-developer sees business in pharma turmoil

Oxford Pharmascience expects the challenges facing biopharm to drive interest in its drug delivery and reformulation technologies.

FDA hits Indian API plant with warning letter & import alert

The FDA has issued a warning letter and import alert to an Indian API manufacturer after finding major cGMP failings.

Pfizer invests $200m in conjugation, pegylation and QC at Ireland plant

Pfizer says investment in Irish manufacturing facility will boost vaccine conjugation and pegylation capacity and establish a new QC testing hub.

News in brief

Isis opens new Cali R&D site

US drug maker Isis Pharmaceuticals has opened a new R&D centre in Carlsbad, California designed to forge closer interdisciplinary bonds.

SAFC sets sights on a "proactive" supply chain management system

SAFC is putting special focus on supply chain and quality management as part of its new strategic plan.

Rx-360 begins audit sharing to raise ingredient quality

Rx-360 has begun its audit sharing programme to increase knowledge about suppliers and the quality of pharmaceutical raw materials.

Drug delivery round-up

in-PharmaTechnologist presents its round-up of the latest in the world of drug delivery, including news from Sanofi Pasteur, Haselmeier, Unigene, and Southwest Research Institute.

Reformulation targeted in FDA unapproved drug plan

The FDA is targeting companies that reformulate drugs to evade enforcement as it tries to crackdown on the 1000s of products marketed without approval.

Pharma discharge checks called for to protect waterways

Researchers have called for closer monitoring of pharma manufacturing discharges after detecting endocrine disruption in fish downstream from a Sanofi plant.

News in brief

Berkshire Hathaway completes $9.7bn Lubrizol acquisition

Chemicals supplier Lubrizol was bought by Warren Buffet’s Berkshire Hathaway group last week in a deal worth $9.7bn (€7.1bn)

Alkermes moves to Ireland and lands multimillion dollar manufacturing deal

Alkermes has celebrated the launch of its new Irish drug delivery and formulation business by winning a new multimillion dollar manufacturing contract with a ‘top 10 pharma.’

GE Healthcare to invest in biomanufacturing tech

GE Healthcare will expand its range of biomanufacturing technologies under a new oncology-focused investment project.

Circassia and NanoPass strike up deal over intradermal device

Immunotherapy and vaccine specialist Circassia says its new license agreement with NanoPass Technologies will help its range of allergy products to thrive on the market.

Vaccine adverse events linked to virus disrupting ingredient

Use of deoxycholate to chemically disrupt influenza viruses during vaccine manufacture could be linked to adverse reactions in children, a journal reports.

Pall ends 2011 on a high as biopharm growth continues

Pall continued the trend seen throughout 2011 by posting double-digit sales growth at its biopharm unit in the fourth quarter.

FDA asks for powers to stop another heparin-like crisis

The FDA needs additional powers to update its “antiquated, domestically-focused statute” and end the “competitive advantage of non-compliance”, an agency official said.

People on the move: pharma jobs

in-PharmaTechnologist.com presents its round-up of the latest pharmaceutical industry appointments, including news from Okairos, Immunovaccine, and SteadyMed.

Albemarle to hike generic API prices on regulatory costs

Albemarle says it will increase what it charges for generic APIs from next month, citing increasing regulatory and testing costs as the main reasons for the hike.

Lonza MA plant sent FDA GMP warning letter about Eisai API

The FDA has sent a warning letter to Lonza’s Hopkinton, MA plant after inspectors found faults with how it produces an oncology API for Eisai.

News in brief

Dosage form monographs next in USP update drive

The USP is to revise over-the-counter (OTC) dosage form monographs as part of its modernisation collaboration with the FDA.

Biocon building Malaysia plant to serve Pfizer insulin deal

Biocon has begun work on the Malaysian biopharm plant that will serve its deal with Pfizer, and is now providing Lipitor ingredients.

Large volume infusion device serves emerging drugs; Unilife

Unilife has developed a wearable infusion device for self-administration of an emerging class of drugs that require large volume doses.

CMC adds capacity at Denmark biologics site

Contract manufacturer CMC Biologics has ramped-up bioreactor capacity to meet demand for biologic drugs for Phase III clinical trials and beyond.

SSB and GE sign patent licensing deal for biomanufacturing techs

Sartorius Stedium Biotech (SSB) and GE Healthcare Life Sciences say new cross licensing deal will aid development of their respective biomanufacturing tech offerings.

Ingredients & formulation research round up

in-PharmaTechnologist presents a roundup of recent ingredient and formulation research, including using NIR-CI to check quality and microwaves to formulate ibuprofen.

Gerresheimer Regensburg expands China facility

Gerresheimer Regensburg GmbH has announced plans to increase production of its medical injection moulders four-fold in its China facility over the next 18 months.

News in brief

Lonza and Fosun strike up joint venture in Shanghai

Lonza Group and Fosun Pharmaceuticals will pump $15.6m (100m yuan) into a joint venture in the Zhangjiang High-Tech Industry Zone, China.

Lanxess set to increase thionyl chloride production in Indian facility

Lanxess have begun plans to increase its production of thionyl chloride by 20 per cent at its plant in Nagda, India.

US to Puerto Rico knowledge transfer cause of quality problems, study

Difficulties transferring know-how from US Pharmas to plants in Puerto Rico may be responsible for the high incidence of manufacturing quality problems on the island, according to the authors of a new study.

Aurobindo forms Russian manufacturing JV

Contract manufacturing organisation (CMO) Aurobindo Pharma has teamed up with Russian supplement maker OJSC Diod to establish a manufacturing joint-venture.

People on the move: pharma jobs

in-PharmaTechnologist presents its round-ups of the latest pharmaceutical appointments, including news from Alegeta, Zealand, Otexs and TYRX.

News in brief

NanoSmart moves to new HQ and begins work on Ab-based delivery tech

Privately-owned US biotech NanoSmart Pharmaceuticals says it has started work on a delivery platform for cancer drugs after moving into a new corporate HQ.

Cellcura signs HSA-free media deal with IDT for vacc development

CellCura has inked an agreement with IDT Biologika for the testing and adaptation of its protein-free (PF) media for the production of cell lines for vaccine manufacturing.

Granted patents strengthens Marina Biotech's peptide drug delivery platform

Marina Biotech has strengthened its nucleic acid-peptide drug delivery platform after being granted the allowance for patents application of a library of novel peptides.

Another AmerisourcBergen acquisition; IntrinsiQ for $35m

AmerisourceBergen has bought informatics firm IntrinsiQ for $35m (€25m) continuing the spending spree it began earlier this week with the acquisition of market access consultancy Premier Source.

Chesapeake to buy Cortegra to build in US

Chesapeake will buy leaflet and label maker Cortegra to strengthen its manufacturing position in the US pharmaceutical packaging market.

Roche launches biomanufacturing monitoring tech

Roche has launched a new analysis platform designed to help bio manufacturers monitor and optimise production operations.

News in brief

Bacteria found in soil used for targeted oncology drug delivery

Researchers at the University of Nottingham, UK, are using a harmless bacteria found in soil as a drug delivery vehicle for oncology.

Toyobo to ramp up injectables CMO biz

Japanese CMO Toyobo says it will increase capacity for injectable drugs to secure its position as a service provider in the expanding biopharmaceutical sector.

update

Bespak diversifies with nasal device development deal

Bespak has won its first nasal delivery device development contract, which it says is evidence its diversification strategy is working.

USP opens expanded Indian testing lab

The US Pharmacopeial Convention (USP) has expanded its quality testing laboratory in Hyderabad in an effort to further strengthen ties with Indian drugmakers and regulators.

News in brief

FDA seeks an extra two-months for its approval process

The US FDA are pushing to extend its approval process by two-months.

New spare parts ordering platform is more efficient and user-friendly, Bosch

A new customised spare parts ordering platform for packaging manufacturers is faster and more user-friendly than its predecessor, said Bosch.

DSM and Sinochem’s anti-infective ingredients JV gets green light

Royal DSM and Sinochem’s anti-infective manufacturing and distribution JV in China has been given the green light by competition authorities.

People on the move: pharma jobs

in-Pharma Technologist brings you its round-up of the new appointments within the pharmaceutical industry, including news from Merck KGaA, Sanofi Pasteur, H&P and CADTH.

In-Pharmatechnologist.com’s GMP regulatory development roundup

in-Pharmatechnologist.com presents a round-up of the latest regulatory developments, including a guide for GMP newbies from Health Canada, an internationally-flavoured revision of the EMA’s rules on batch certification and the EDQM’s latest thoughts membrane-based on WFI production.

News in brief

Systech & Zetes partner to meet EU serialisation needs

Systech International and Zetes have partnered to offer European pharmaceutical manufacturers serialisation systems.

CareFusion suing Hospira over drug delivery patents

CareFusion is suing Hospira and seeking damages over alleged infringement of patents protecting its drug delivery systems.