The almost-private China-based CDMO (contract development and manufacturing organization) WuXi is looking to reap larger rewards from investing in US and China pharma and biotech firms.
CDMO (contract development and manufacturing organization) Aptuit is investing in additional scale and capabilities at its Italian site to augment its 1600L scale API capability and to add a commercial GMP license.
CiMaas BV, a company developing cellular immunotherapies to treat cancer, has selected CMO (contract manufacturing organization) PharmaCell, to help in the clinical development and manufacturing of CiMaas’ ATMPs (Advanced Therapy Medicinal Products).
Antibiotic API makers have an obligation to ensure their activities do not spread resistance says a group that welcomed DSM-Sinochem’s commitment to environmentally-friendly production.
China-based CDMO (contract development and manufacturing organization) WuXi PharmaTech has raised about $80m for subsidiary SynTheAll Pharmaceutical Co. (STA) via the private placement of 7.16m common shares of STA stock.
Following an FDA inspection in March, Catalent’s Center of Excellence for Analytical Services in Morrisville, NC was hit with a Form 483 with six observations.
An operational rejig at DPT Laboratories, an expansion at UDG, and a synthesis and toxicology testing contract win for Dalton – welcome to Outsourcing-Pharma’s CDMO round-up.
Catalent has licensed an expression technology from Excelimmune it says could offer biologics makers a cost-effective and simple way to make antibody combination therapies.
Biocorp has raised €8.9m ($9.8m) through an IPO during what it called a period of “deep macroeconomic uncertainty” and has underlined plans to grow its drug delivery tech business internationally.
While pharma and biotech companies are increasingly turning to CMO (contract manufacturing organization) partners earlier in the drug development process, they may want to reconsider engaging with a CMO prior to filing a patent after a recent ruling from...
As biopharmaceutical companies look to cut costs and understand their core competencies further, the use of outsourcing and off-shoring have become even more mainstream than in years past, according to the 12th annual biomanufacturing report from BioPlan...
GSK’s HIV unit ViiV Healthcare and China-based Desano Pharmaceuticals have forged an agreement whereby Desano will manufacture the API of GSK’s HIV drug Tivicay (dolutegravir) in China.
Manufacturing operations at an Actavis legacy site in Iceland will cease and products will be transferred out the country from 2016, Allergan has announced.
Hospira has begun commercial production at a sterile injectable plant in India hit with several 483 forms after the US FDA deemed the site ‘acceptable.’
GSK is investing £38m ($60m) in enzymatic manufacturing at an antibiotic facility in Singapore which the firm says is greener and more efficient than traditional approaches.
Transgene will close a biomanufacturing facility with the loss of 120 jobs to cut costs after Novartis pulled out of an immunotherapy collaboration last year.
Juniper Pharma Services has won a contract to manufacture ‘sono-sensitive particles’ used to aid delivery of cancer drugs into solid tumours for OxSonics.
The proposed Perrigo merger with Mylan would be of no benefit to either firm in the “highly competitive” OTC sector, according to financial analysts BMO.
Swiss CMO Lonza and Canada’s Octane Biotech have entered an exclusive technology evaluation of the Octane Cocoon cell production platform for personalized cell therapy manufacturing with the goal of a global deployment.
TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.
In a rare move for the UK’s MHRA (Medicines and Healthcare products Regulatory Agency), the regulator has helped to “future-proof” CMO Fujifilm Diosynth Biotechnologies’ mammalian cell culture manufacturing facility in Billingham, UK against potential...
Small-scale production techs will dominate biopharma says the UK organisation tasked with developing the £20m “biologics factory of the future” and the £38m National Biologics Manufacturing Centre in Darlington.
Vaccine developer Aeras and CMO (contract manufacturing organization) IDT Biologika have formed a strategic partnership that includes the acquisition of Aeras's Biopharmaceutical Development Center (BDC) manufacturing facility by IDT.
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.
Raffles PharmaTech has contracted ScinoPharm to make the API for a generic version of the arthritis pain drug celecoxib being developed for the US market.
Novasep has signed two partnership agreements for the Japanese markets. The agreements were with Allied Laboratories, a life science and chemical consulting company, and with AR Brown, which will represent Novasep’s CMO services in the Japanese market.
The patent cliff and biopharmaceuticals have driven opportunities for pharma packaging companies, which say they are opting to grow through innovation rather than M&A.
A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.
An expansion at Vetter, a contract win for Dalton and a pre-approval inspection at LSNE – welcome to Outsourcing-Pharma’s round-up of sterile manufacturing news.
Site audits by Brazilian pharma regulator ANVISA are “exactly the opposite” to the US FDA’s, says CMO Kemwell as it prepares to export to Brazil for Johnson & Johnson.
Aspyrian Therapeutics has selected CDMO Goodwin Biotechnology to complete process development, scale-up, and cGMP manufacturing of their novel antibody drug conjugate (ADC).
US-based contract development and manufacturing organization (CDMO) Patheon has registered with the SEC as part of plans to go public with an IPO that could be worth as much as $100m.
Teva has refuted accusations of “meddling” with Mylan’s business in the latest chapter of what one analyst says is a far from friendly, if not hostile takeover attempt.
