VGXI, a subsidiary of GeneOne, signed a licensing agreement with Houston Methodist Research Institute to produce RNA one of the most valued clinical ingredients.
In the days of personalised medicine, 3D printing and nanotechnology, consultant David Chesney says regulators must “keep pace” to redefine current good manufacturing practice.
Almac will “eventually” move into sterile injectables says executive Brian Eastwood, adding the market has good potential for growth in the contract manufacturing space.
The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.
The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.
An Indian TB drugmaker has been hit with a WHO Notice of Concern but an independent audit carried out by its customer Svizera Europe disputes the GMP violations raised.
In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices)...
Health Canada is telling drug and API manufacturers that it’s going to ramp up announced and unannounced inspections due to concerns raised around APIs and data integrity, and the findings will be published online beginning next month.
The biotech boom of over 165 IPOs in 2013 has resulted in earlier and more lucrative work for CMOs (contract manufacturing organizations), experts say.
Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.
Onyx Scientific, a UK contract development and manufacturing organisation (CDMO) has completed an API (active pharmaceutical ingredient) production deal for Neuronascent, a US company developing neurological therapies.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has withdrawn its good manufacturing practice certificate for Wockhardt’s Chikalthana, India-based plant due to cGMP violations.
Evonik gets the thumbs up from the MHRA, Recipharm's approved by Japan and Simcere passes the Chinese regulatory test – welcome to Outsourcing-Pharma’s round-up of GMP accreditation.
IPEC (International Pharmaceutical Excipients) Federation is calling on foreign gelatin makers to set up manufacturing plants in India in a bid to tackle an “acute” shortage of the excipient.
The US FDA has finally become a member of the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC/S) after a five-year application process.
KV Pharmaceutical has reported that an independent expert has re-inspected its facility and found it to be in compliance with good manufacturing practices (GMP).
The Hong Kong pharma sector should aim to adopt current World Health Organisation (WHO) GMP standards for drug manufacture within two years, according to a new report.
O’Hara Technologies has launched a lab-scale tablet coating system that incorporates a blender and tray dry oven inserts to cut capital expense and GMP spaced needed perform these tasks.
The Indian government is planning on establishing pharmaceutical zones at major international airports to facilitate exports, according to local media reports.
Patheon hopes that a new pharmaceutical development services (PDS) suite at its facility in Whitby, Ontario will complete its “Quick to Clinic” offering and provide a rapid-response means of making solid dosage forms for trials.
Ranbaxy’s antiretrovirals zidovudine, lamivudine, and nevirapine have been removed from PEPFAR’s list of approved products until ongoing GMP problems at two of the firm’s Indian manufacturing plants are resolved.
Sancilio & Co (SCI) says that its new contract manufacturing plant in Riviera Beach, Florida can provide pharmaceutical manufacturers with small batch production capacity for drug tablets and capsules.
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.
Outsourcing-Pharma.com presents a round-up of recent contracts
signed in the manufacturing arena, featuring new deals for Angel
Biotechnology, PharmEng and Akela Pharma.
Auditing firm blue inspection body (BIB) has achieved a type 'A'
independence rating under German accreditation organisation DAP's
scheme to certify the third-party inspection of active
pharmaceutical ingredient (API)...
French firm Novasep has significantly upped its capacity with a new
high potency active pharmaceutical ingredient (HPAPI) plant at its
facility in Le Mans, France.
US biopharmaceutical company CytoGenix has announced breaking
ground on a new $3.8m facility to expand the company's
manufacturing capability of synthetic DNA.
Screening and processing equipment supplier Kason, were out in
force at InterPhex 2006, with a range of products that aid the
manufacturing industry meet stringent pharmaceutical sanitary
requirements.
Information technology giant IBM has developed a software
architecture that promises to modernise the pharmaceutical
industry's manufacturing processes, often accused of lagging behind
those of other industries such as chemicals...
In an unusual move, Finnish science park Medipolis has set up a new
Good Manufacturing Practice (GMP) pilot plant to take advantage of
the growing demand for biopharmaceutical production capacity.
Cambridge Major Laboratories expects to complete construction of a
new process R&D and manufacturing facility in the middle of
2004 that will make it one of the largest Good Manufacturing
Practice (GMP) development and small-scale...
The US Food and Drug Administration is gearing up for the first
major overhaul of its current Good Manufacturing Practice
guidelines in 25 years, according to the agency's Commissioner Mark
McClellan. The move is just one strand...
