Continuous manufacturing equipment installed at a CordenPharma French facility has reduced cycle time and cost of making a hypertriglyceridemia drug, says Acasti Pharma.
The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.
Lonza and Boehringer-Ingelheim dominate the consolidated biologics CMO space but disposable technologies and improved yields are beginning to change this, says PharmSource’s Jim Miller.
Xinxiang Tuoxin Biochemical has received a US FDA warning letter after manufacturing equipment at two API facilities were found to be in a state of disrepair.
Regulations, recruitment and facility refits are holding continuous manufacturing back, but a Rutgers’ associate behind J&J’s recent success believes industry can overcome these hurdles.
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.
While CMOs are currently engaged mainly through tactical outsourcing, this paradigm will shift as more companies begin outsourcing to preferred providers, says ISR report.
Software firm LZ Lifescience says small drugmakers could increase their productivity by over 25% by accessing Manufacturing Execution Systems (MESs) traditionally restricted to Big Pharma firms
As CMOs wait to see the short-term fallout of the Pfizer-Allergan deal, an M&A expert says contract manufacturing will follow the CRO industry in embracing strategic alliances and consolidation.
The UK biopharma industry is reporting difficulties finding manufacturing workers with the skills to make vaccines, biologics, and advanced therapy medicinal products (ATMP), according to ABPI.
CMO consolidation strategy has shifted from building scale and adding geographies towards niche technologies and biologics, according to the founder of trade association PBOA.
Cobra Biologics, a Swedish contract development and manufacturing organisation, has launched a project to improve scale-up of biologics with the University of Manchester, UK.
A Standards & Poor analyst has rated contract development and manufacturer AMRI as ‘stable,’ but says it lacks the scale and breadth of offerings of its competitors in the CDMO industry.
A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption...
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.
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.
US production of chemicals for the drug industry fell in April according to data released days after renewed calls for permanent tax breaks to help American manufacturers compete globally.
Reliance on CMOs and CROs has allowed the flexibility to make Gilead a top 10 pharma firm, and the use of third-parties will remain part of its strategy according to the CFO.
A lack of scientific talent will hold pharma back from adopting continuous manufacturing despite the imminent opening of regulatory pathways, says an MIT Professor.
Capsugel says it is bolstering its service to offer specialised dry powder inhalation (DPI) formulations, allowing biotherapeutics to be delivered to the lung rather than by injection.
Persuading API manufacturers to seek prequalification is a challenge according to the WHO, which wants to raise awarness about the process and the positive impact it has on a suppliers' reputation.
WuXi PharmaTech subsidiary WuXi Biologics has begun construction on a new $150m biologics manufacturing facility in Wuxi, China, which is expected to be the largest mammalian cell culture manufacturing sire using disposable bioreactors in the world.
Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma manufacturers and CMOs should begin to consider the switch as in the long-run it will end up saving companies time, money and space, FDA’s...
China-based contract research and manufacturing company WuXi PharmaTech has received a proposal to be taken private by a consortium led by its CEO and Ally Bridge Group Capital Partners.
Cell-based cancer immunotherapy company Juno Therapeutics has entered into a lease agreement for a manufacturing facility in Bothell, Washington to produce its developing cell therapies.
Banishing kettles, 'Gemba walks' and encouraging employees to report near misses have helped Penn Pharma to remain accident free at its high potency compound manufacturing facility in Wales.
The agency issued a warning letter and withdrew the GMP (Good Manufacturing Practice) certificate from Hyderabad, India-based Sri Krishna Pharmaceuticals for 10 GMP deviations found during an inspection at its Nacharam granulation plant in December.
Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”
