22-Sep-2016 By Melissa Fassbender
In its first year of operations, IDT Biologika’s contract manufacturing facility in Rockville, Maryland has experienced rapid growth, which it expects to continue as construction carries on.
12-Jan-2016 By Melissa Fassbender
According to analysts, the vaccine contract manufacturing market is poised for growth, and change, as new players emerge in the East.
05-Dec-2014 By Dan Stanton
Novartis has spoken about the extensive safety testing at its production sites after its seasonal flu vaccine Fluad was found to be unconnected to 19 deaths in Italy.
02-Dec-2014 By Dan Stanton
Novartis’ seasonal flu vaccine Fluad has been deemed safe by the Italian Medicines Agency (AIFA) after testing the two batches connected to over a dozen deaths.
01-Dec-2014 By Dan Stanton
The EMA is investigating over a dozen deaths in connection with Novartis’ flu vaccine Fluad, following the suspension of two batches in Italy.
27-Nov-2014 By Dan Stanton
Just in time for the holidays, GSK can ‘give thanks’ to the US Federal Trade Commission (FTC) which has approved the $7bn acquisition of Novartis’ vaccine business.
03-Nov-2014 By Zachary Brennan
Two major influenza vaccine producers have run into manufacturing issues that have delayed and reduced the number of doses that will be provided for the US.
22-Oct-2014 By Dan Stanton
A seasonal flu vaccine taken in the form of an oral solid dose has been found comparable to currently available jabs, according to data presented by developer Vaxart.
07-Oct-2014 By Gareth Macdonald
AstraZeneca’s biologics wing MedIummune has been granted a US patent for an optimised cell line used to make infleunza vaccine.
13-Aug-2014 By Zachary Brennan
Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.
16-Jul-2014 By Gareth Macdonald
Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.
25-Jun-2014 By Gareth Macdonald
GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing endotoxin contamination problems at a Canadian plant hit with US FDA warning letter.
Dispatches from BIO 2014
24-Jun-2014 By Zachary Brennan
Texas-based Kalon Biotherapeutics is in the process of building two new biomanufacturing facilities, including a $91m facility to produce flu vaccines for GlaxoSmithKline.
23-Apr-2014 By Zachary Brennan
Novartis has agreed to acquire GlaxoSmithKline’s oncology pipeline for as much as $16bn, while GSK will acquire Novartis’ vaccine business, excluding the flu vaccines, for as much as $7bn.
09-Apr-2014 By Zachary Brennan
Recent outbreaks of a strain of meningitis, known as “serogroup B” or “MenB”, on US college campuses have caused both Pfizer and Novartis to develop new vaccines.
17-Oct-2013 By Gareth Macdonald
The US Government Shutdown has delayed the regulatory review of a new egg-free influenza vaccine production process developed by Protein Sciences.
28-May-2013 By Dan Stanton
Vaccine manufacturer Sinovac has updated its GMP accreditation to international standards, short of the deadline set by the CFDA.
12-Nov-2012 By Gareth Macdonald
Italian regulators have lifted a temporary ban on two Novartis flu vaccines in which high levels of protein aggregates were detected.
29-Oct-2012 By Gareth Macdonald
Novartis says two seasonal influenza vaccines temporarily banned by several European countries on quality concerns are safe.
19-Jun-2012 By Nick Taylor
HHS is investing $400m (€318m) to create centres to speed development and production of medical countermeasures.
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.
Vaccine cell line demand helps Vivalis cut loss in H1
31-Aug-2011 By Nick Taylor
Vivalis cut its operating loss after demand for its vaccine production cell line drove triple-digit revenue growth.
CSL receives US FDA warning for GMP violations at vaccine plant
28-Jun-2011 By Gareth Macdonald
Australia’s CSL Biotherapies has received a warning letter from the US FDA for GMP deviations at its vaccine production plant in Parkville, Victoria.
Lower clinical trial spend helps Novavax halve operating loss
29-Mar-2011 By Nick Taylor
Novavax halved its operating loss in the fourth quarter as a result of lower clinical trial spending.
LG to build VLP vaccine site in S Korea using Novavax tech
01-Mar-2011 By Nick Taylor
LG Life Sciences is to build an influenza vaccine production facility in South Korea after licensing technology from Novavax.
18-Oct-2010 By Gareth Macdonald and Claire Videau
IDT Biologika.says demand for vaccines in emerging markets is big chance for Big Pharma and hence a growing niche for contractors with the technical capabilities to carry out such work.
Novartis and Synthetics Genomics Vaccines to co-develop synthetic flu vaccines
11-Oct-2010 By Alexandria Pešić
Novartis will use technology from Synthetics Genomics Vaccines to speed up the development of influenza vaccines for seasonal and pandemic flu outbreaks.
US gov support needed for overhaul of vacc production
31-Aug-2010 By Nick Taylor
Cell culture, LAIV vaccines and recombinant DNA technology should be supported by the US government as part of a long-term overhaul of pandemic response capabilities, according to PCAST.
Pandemic vaccine production time could be halved in 3 years
A review of US capabilities has concluded that the time to produce a pandemic vaccine could be halved through adoption of short-term policies.
BARDA funding vaccine capacity creation in developing world
12-Aug-2010 By Nick Taylor
BARDA is providing the WHO with $6.4m (€5.0m) to cooperatively develop influenza vaccine production capacity in under-resourced nations.
Abbott exploring sale of vaccines unit
05-Jul-2010 By Gareth Macdonald
Abbott Laboratories has confirmed it is considering the sale of the vaccines unit it gained with the €4.5bn ($6.2bn) acquisition of Solvay Pharmaceuticals in February.
Zydus begins H1N1 trials
05-Jan-2010 By Nick Taylor
Zydus Cadila has become the first Indian pharma company to begin multi-centre clinical trials of a H1N1 vaccine after it received approval from the Drug Controller General of India (DCGI).
Sanofi boosts syringe and vacc capacity at French plant
15-Dec-2009 By Gareth Macdonald
Sanofi Aventis has revamped operations at its sterile injectables plant in Le Trait, France, adding three new production units that double syringe making capacity and diversify its vaccine manufacturing capability.
Unilife files US patents for “world first” RTF vacc syringe; mulls Nasdaq listing
30-Nov-2009 By Gareth Macdonald
Unilife Medical Solutions has filed US patents for Unifill Select, which it claims is the first ready-to-fill (RTF) syringe specifically designed for vaccine delivery.
Norvartis’ US cell vacc plant could make adjuvant in December
25-Nov-2009 By Gareth Macdonald
Novartis says its new cell culture plant in Holly Springs, North Carolina could begin making its flu vaccine boosting MF59 adjuvant as early as next month if approved by US regulators.
West laying off 100 staff
04-Nov-2009 By Nick Taylor
West Pharmaceutical Services is laying off 100 staff as part of restructuring efforts after its third quarter results fell short of expectations, despite operating profit increasing by 45 per cent.
Work begins on Indian seasonal flu vacc plant
29-Oct-2009 By Gareth Macdonald
Novavax says its new Indian vaccine plant will be operational in four months with sufficient capacity to help meet local demand for seasonal influenza vaccines.
SFDA set to approve two H1N1 vaccines
02-Sep-2009 By Nick Taylor
In the next week the Chinese SFDA is expected to approve licences for two locally produced H1N1 vaccines, which unlike some alternatives only require one dose to confer immunity.
KBI rolls out PER.C6 service in US
25-Jun-2009 By Gareth Macdonald
US contract services firm KBI Biopharma has begun using the PER.C6 platform for cell line generation as part of its offering to meet growing demand for biomanufacturing services.
Strong growth predicted for Chinese vaccine market
22-Jun-2009 By Nick Taylor
The growth of the Chinese vaccine market is set to outstrip the country’s pharma sector, according to a Frost & Sullivan (F&S) report that predicts 14-15 per cent CAGR.
Millipore’s deal to improve influenza vaccine purification
27-Apr-2009 By Nick Taylor
Millipore is collaborating with Microbix Biosystems to improve influenza vaccine manufacturing by developing a purification process using novel chromatographic technology.
Novartis bids for greater share of Indian subsidiary
Novartis is looking to buy an additional 39 per cent of its majority-owned subsidiary Novartis India for around 4.4bn rupees ($87m), or 351 rupees per share.
21-Jan-2009 By Gareth Macdonald
Late last week the US Department of Health and Human Services (HHS) awarded Novartis a $490m contract to continue work on its cell-culture influenza vaccine plant in Holly Springs, North Carolina, US. in-PharmaTechnologist spoke with Novartis spokesman...
Novartis gets $487m for US cell culture flu vac plant
19-Jan-2009 By Gareth Macdonald
Novartis will receive a further $487m (€366m) from the US HHS for its cell-culture flu vaccine plant in Holly Springs, North Carolina.
Baxter uses cell culture for H5N1 vaccine
17-Jun-2008 By Nick Taylor
Baxter has successfully produced H5N1 influenza vaccine in African
green monkey kidney cells in quantities sufficient for clinical
testing, according to an article published in The New England
Journal of Medicine.
Pharmaceutical manufacturing: people on the move
15-May-2008 By Nick Taylor
in-PharmaTechnologist.com presents its periodic round-up of
personnel changes in pharmaceutical manufacturing and development.
US govt pays Sanofi Pasteur $192m for bulk flu antigen
29-Apr-2008 By Gareth Macdonald
The US Department of Health and Human Services (HHS) has accepted a
bulk stock of H5N1 influenza virus antigen, consisting of both
hemagglutinin and neuraminidase, worth $192m (€123m) from French
vaccines specialist Sanofi Pasteur.
Novartis warned as facility fails inspection
04-Feb-2008 By Huw Kidwell
Novartis has been given a warning by US regulators detailing
significant failures in its investigation into tracking down the
source of contamination in some of its vaccines.
GE Healthcare and Novavax collaborate on pandemic flu solution
11-Dec-2007 By Staff Reporter
GE Healthcare and Novavax have a vision - a state-of-the-art
pandemic influenza vaccine manufacturing facility solution with the
ability to produce vaccines quickly, which can be marketed as a
product to international countries.
Sanofi steps up Asian investment
06-Dec-2007 By Kirsty Barnes
Sanofi-Aventis has opened its first Asian research and development
centre in Goa, India, signalling its ambition to further tap in to
this region's budding pharma scene.