Protein A is essential in keeping the costs and complexity of purifying monoclonal antibodies down, says GE Healthcare as it extends its supply agreement with Repligen.
Potentially hazardous bio-waste generated at the UK National Biologics Manufacturing Centre (NBMC) in Darlington is being made safe using a bespoke system developed by Suncombe.
Cell Therapy Manufacturing & Gene Therapy Congress - Brussels, Belgium
The shelf life of a cell therapy product is crucial in determining a firm’s manufacturing strategy according to the makers of the first approved stem-cell based drug.
Athenex will invest a minimum of $1.62 bn over the next ten years in labor, materials, and supplies, to create a new manufacturing facility and to expand its North American headquarters.
Cell therapy development and production will not be sustainable unless there is a vendor-led shift to automated processes, said experts in Brussels yesterday.
Reneuron has been granted a US patent for a cryopreservation technology that does not rely on toxic reagents and says it would consider licensing it to other stem cell therapy developers on a case-by-case basis.
Biocision has revamped its cell thawing platform to accommodate larger vial sizes and started developing an automated system for cell therapies in cryopreservation bags.
More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.
Yan Mei, a defendant charged with stealing GlaxoSmithKline (GSK) trade secrets including biopharmaceutical manufacturing processes, remains at large, a spokesperson for the US Attourney's office told us yesterday.
Sartorius Stedim Biotech has launched a crossflow filtration system for scaling studies and low volume options normally available with process systems.
GE Healthcare has teamed up with the Canadian Government and the Toronto-based Centre for Commercialization of Regenerative Medicine develop cell therapy manufacturing technologies.
Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.
If ‘Love is the drug’ should Roxy Music be subject to regulatory scrutiny? Can The Verve say ‘The drugs don’t Work’ without conducting a clinical trial? We explore the harmonious worlds of pharma and music.
Protea Biosciences has teamed up with Agilent Technologies to offer drugmakers mass spectrometry alternatives to UV detection in QA/QC of recombinant proteins.
Analytical and downstream technology firm Waters has opened a subsidiary in Malaysia, citing the steady and consistent growth of biopharma in the region as a driver.
New acquisition Sigma Aldrich will play a part in African growth plans in addition to giving it a presence in the preclinical services sector says Merck*.
Takeda has taken a stake in Belgian bioprocessing start-up Univercells as part of a programme aimed at supplying low-cost vaccines to lower-income countries.
A single-use nanofibre-based purification technology could overcome limitations of current chromatography processes says Puridify, which has raised an additional £2.2m ($4m) in funding.
Rival injectable drug contractors were felled by a stricter MHRA take on rules says Symbiosis' CEO who is confident his firm's compliance record will help it thrive.
Repligen could reap the financial rewards from two recently approved cholesterol-lowering proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors, a Jefferies analyst says.
Shire will use contractors to increase production of Cinryze, the half billion dollar-a-year Hereditary Angioedema (HAE) drug it bought with ViroPharma in 2014.
Sartorius finished the first half of 2015 with increased sales, higher operating profits and a surge in orders that prompted it to raise its full year forecast.
CDMO (contract development and manufacturing organisation) Goodwin Biotechnology is working with CNS biotech Q Therapeutics to produce mAbs for a clinical trial to treat motor neuron disease.
ReNeuron will automate processing of its stem cell-based stroke therapy ahead of planned Phase III trials using a system acquired from Sartorius Stedim Biotech (SSB) subsidiary, TAP Biosystems.
Biotech company Biogen plans to invest one billion Swiss francs ($1.1bn) in Solothurn, Switzerland to build a new production plant that will create about 400 new jobs beginning in 2019.
TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.
TxCell has suspended production at its plant in Besancon, France as it works to eliminate the risk cell therapies made there are contaminated by bacteria.
German-based contract manufacturer apceth has received regulatory approval to use two new GMP cleanrooms for aseptic processing, which will be used for the handling and genetic manipulation of various types of cell and gene therapies.
EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.
