Bend Research gets novel formulation boost through Hovione manufacturing deal
20-Oct-2011 By Natalie Morrison
Novel drug formulations specialists Bend Research will receive manufacturing manpower from Hovione, after inking a nonexclusive agreement.
VaxyGen & Georgia State join for protein purification services
20-Oct-2011 By Nick Taylor
VaxyGen is working with Georgia State University (GSU) to offer protein purification, optimisation and production services.
Abbott likely to retain CMO biz after split
20-Oct-2011 By Gareth Macdonald
Abbott says its contract manufacturing business is likely to be part of the diversified drug company formed after its planned corporate split.
Avantor to add tamper-evident seals to raw material containers
20-Oct-2011 By Nick Taylor
Avantor is to offer tamper-evident seals on all its pharma raw material and excipient containers by the end of the year.
Ongoing quality problems at injectables plant hurt Hospira in Q3
19-Oct-2011 By Gareth Macdonald
Hospira says ‘quality actions’ taken to fix problems at key injectable drug manufacturing plant in US reduced its third quarter earnings.
GSK hit with warning letter as FDA finds faults with UK site
19-Oct-2011 By Nick Taylor
The FDA has sent GSK a GMP warning letter after finding failings in steps to prevent microbiological contamination at a UK site.
Canadian drug shortage plan fails to tackle problems; analyst
19-Oct-2011 By Nick Taylor
Canadian pharma manufacturers’ plan to stop drug shortages by sharing information fails to tackle underlying concerns, an analyst said.
CMO Angel & Russian pharma plan drug production JV
18-Oct-2011 By Nick Taylor
Angel Biotechnology is negotiating a joint-venture with a Russian firm that would see it add dedicated production space at a UK site.
Tech needed to cut rise of fake drugs on Twitter, research says
17-Oct-2011 By Nick Taylor
Spam filtering and identification is needed to stop Twitter becoming another platform for pushers of fake or substandard drugs, researchers say.
17-Oct-2011 By Natalie Morrison
The Chinese Food and Drug Administration (SFDA) plans to ramp up cash rewards for whistleblowers who flag illegal goings on within the Chinese drugs manufacturing sector.
Porcine trypsin guidance may apply retrospectively; EMA
13-Oct-2011 By Nick Taylor
The EMA may apply proposed porcine trypsin guidelines to existing products, such as a GSK vaccine, to cut viral contamination.
EPA proposes fine for API plant over waste allegations
12-Oct-2011 By Nick Taylor
The US EPA plans to fine API manufacturer Rhode Technologies for alleged hazardous waste failings at its plant.
FDA releases final guidance on anti-counterfeiting excipients
12-Oct-2011 By Nick Taylor
The FDA has published final guidance on the use of excipients as anti-counterfeiting tools in solid oral dosage forms.
Biologics growth prompts IMB cold-chain distribution guidance
11-Oct-2011 By Nick Taylor
The Irish Medicines Board (IMB) has published guidance for cold-chain storage and transport of APIs and finished products.
11-Oct-2011 By Gareth Macdonald
The United States Pharmacopeial Convention (USP) has forged closer ties with Russian regulators to help tackle substandard pharmaceuticals and harmonize quality standards.
Vetter opens new US production facility
06-Oct-2011 By Natalie Morrison
Vetter says it will reduce API wastage through its new US production facility for the filling of syringes, cartridges and vials.
Akorn to enter India in five facility takeover deal
06-Oct-2011 By Nick Taylor
Akorn is to expand its CMO business into India and add sterile injectables capabilities by acquiring five manufacturing plants.
Solvias and RohnerChem team on API development and manufacturing
05-Oct-2011 By Gareth Macdonald
Solvias and RohnerChem have set up a research and manufacturing services partnership designed to accelerate the production, scale-up and commercialisation of APIs.
Influenza pandemic prompts EMA vaccine quality rethink
04-Oct-2011 By Nick Taylor
The EMA is developing new vaccine quality guidelines in response to shortcomings seen during the influenza pandemic.
Inspection data to be opened up in FDA transparency plan
04-Oct-2011 By Nick Taylor
The US FDA may add product and violation-specific searches to its publicly available database of inspections as part of a transparency push.
Aesica plans expansion in US & Asia after investment
03-Oct-2011 By Natalie Morrison
CDMO Aesica is to add manufacturing capacity in Asia and the US following a cash injection from private equity firm Silverfleet Capital.
TGA proposes adopting 15 EMA guideline documents
03-Oct-2011 By Nick Taylor
The Australian TGA is considering adopting EMA guidance on residual solvents, genotoxic impurities and other GMP topics.
29-Sep-2011 By Nick Taylor
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.
J&J hunting for new CMO for Doxil
28-Sep-2011
Supplies of Johnson & Johnson’s Doxil cancer drug will be cut down in coming months as the company transitions to a new manufacturer.
CMLE OKed to start commercial API production at Netherlands plant
27-Sep-2011 By Gareth Macdonald
Cambridge Major Laboratories Europe (CMLE) is set to start commercial API manufacturing at its facility in the Netherlands after approval by Dutch regulators.
Teva pharma swallows up Kowa's half of joint venture
26-Sep-2011
Teva Pharmaceutical Industries is set to buy out Kowa Company’s half of its joint Japanese venture for $150m (€111m).
26-Sep-2011 By Natalie Morrison
Novozymes has achieved a successful supply chain and risk mitigation strategy through implementing its own policy with chemicals company SAFC, says Luke Dimasi.
ProMetic supplying adsorbent to Chinese biosimilar biz
26-Sep-2011 By Nick Taylor
ProMetic Life Sciences is supplying an affinity adsorbent to a Chinese biopharm for use in scale-up of a biosimilar.
Crystallisation modelling can improve scale up, PSE says
26-Sep-2011 By Nick Taylor
Process Systems Enterprise (PSE) has developed crystallisation modelling software to improve throughput and simplify scale-up.
SCM Pharma launches formulation development service
26-Sep-2011 By Alexandria Pesic
UK-based SCM Pharma is to begin offering formulation development services as part of a collaborative deal with the University of Sunderland.
Ukraine votes to criminalise drug counterfeiting
26-Sep-2011 By Alexandira Pesic
Ukraine's parliament, the Verkhovna Rada, has voted unanimously in favour of new legislation which will criminalise the production and trafficking of counterfeit drugs.
PerkinElmer's new service aims to speed up instrumentation qualification
22-Sep-2011 By Natalie Morrison
PerkinElmer has launched its new Universal Operational Qualification (UOQ) service for pharmaceutical labs.
West-Ward wants CMO market share after Baxter buy
22-Sep-2011
West-Ward is working to win contract manufacturing market share and tackle drug shortages after buying assets from Baxter.
AAIPharma adds online raw material testing system
22-Sep-2011 By Nick Taylor
AAIPharma Services has created a 24/7 online quote generation and sample submission service to simplify raw material testing requests.
FDA hits Indian API plant with warning letter & import alert
22-Sep-2011 By Nick Taylor
The FDA has issued a warning letter and import alert to an Indian API manufacturer after finding major cGMP failings.
Amrutanjan to bolt CMO services on to fine chemicals unit
21-Sep-2011
Amrutanjan Health Care plans to add contract manufacturing and custom synthesis to services offered by loss making fine chemicals business, according to various reports.
Catalent and Toyobo team up to launch GPEx in Japan
21-Sep-2011 By Natalie Morrison
Catalent has struck up a deal with Toyobo Biologics to launch its cell line engineering technology on the Japanese market.
Pfizer invests $200m in conjugation, pegylation and QC at Ireland plant
21-Sep-2011 By Gareth Macdonald
Pfizer says investment in Irish manufacturing facility will boost vaccine conjugation and pegylation capacity and establish a new QC testing hub.
Pharma discharge checks called for to protect waterways
20-Sep-2011 By Nick Taylor
Researchers have called for closer monitoring of pharma manufacturing discharges after detecting endocrine disruption in fish downstream from a Sanofi plant.
19-Sep-2011 By Natalie Morrison and Claire Videau
SAFC announced its new aggressive growth strategy, including plans to expand in the developing markets, at its conference in Irvine, Glasgow last week.
GE Healthcare to invest in biomanufacturing tech
19-Sep-2011 By Gareth Macdonald
GE Healthcare will expand its range of biomanufacturing technologies under a new oncology-focused investment project.
15-Sep-2011
International nutra and pharma contract manufacturing organisation, Catalent, has expanded its Italian operations and diversified its potential in vitamins, minerals and supplements.
Pall ends 2011 on a high as biopharm growth continues
15-Sep-2011 By Nick Taylor
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
15-Sep-2011 By Nick Taylor
The FDA needs additional powers to update its “antiquated, domestically-focused statute” and end the “competitive advantage of non-compliance”, an agency official said.
Lonza MA plant sent FDA GMP warning letter about Eisai API
14-Sep-2011 By Nick Taylor
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.
CMC adds capacity at Denmark biologics site
13-Sep-2011
Contract manufacturer CMC Biologics has ramped-up bioreactor capacity to meet demand for biologic drugs for Phase III clinical trials and beyond.
Patheon plans facility exits & capability cuts to improve biz
13-Sep-2011 By Nick Taylor
Patheon is exiting semi-solids, clinical packaging and cutting facilities in response to ‘poor historical performance’.
SSB and GE sign patent licensing deal for biomanufacturing techs
13-Sep-2011 By Gareth Macdonald
Sartorius Stedium Biotech (SSB) and GE Healthcare Life Sciences say new cross licensing deal will aid development of their respective biomanufacturing tech offerings.
Aurobindo forms Russian manufacturing JV
08-Sep-2011 By Gareth Macdonald
Contract manufacturing organisation (CMO) Aurobindo Pharma has teamed up with Russian supplement maker OJSC Diod to establish a manufacturing joint-venture.
08-Sep-2011 By Gareth Macdonald
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.
