Harpoon Therapeutics has selected CMC Biologics to develop and manufacture three molecules for cancer treatments at the CDMO’s facilities in California and Washington State, US.
Augmented reality has unlimited potential and will address the pharmaceutical industry’s need for greater control over efficiency, safety, and reliability, says Apprentice CEO.
Three-dimensional printing technology is attracting increased attention from the US FDA say Aprecia and Cycle, which have announced a partnership to develop 3D-printed orphan drugs.
Only eight of the top 40 CROs are Privacy Shield Framework-certified, says Science Exchange CEO as the company continues to rack up partnerships with pharma companies looking to streamline outsourcing efforts and mitigate risk.
By Sudip S. Parikh, PhD, senior vice president & managing director, DIA Americas
The healthcare product development ecosystem is undergoing massive changes. Significant transformations are underway in how drugs and medical devices are researched, developed, manufactured, and approved.
The US FDA made one observation at the finished dose formulation in Chantilly, Virginia bought by Indian drugmaker Granules from Valeant Pharmaceuticals in 2014.
Regulatory changes and promising starts ups are fueling demand for outsourced services in China – and as venture capital flows into the country, the pace of innovation is expected to accelerate, says STA Pharmaceutical.
Apprentice has raised $2.5m in venture funding for its augmented reality solution, Affinity, which is designed to improve productivity, audit readiness quality, and safety within pharmaceutical lab and research environments, says CEO.
Wasdell Group will invest €30m in a packaging, testing and distribution facility in Ireland, which it says could help UK and US customers serve European clients post-Brexit.
Tjoapack has tripled its bottle packing capacity as increased legislative complexity, ageing populations and pricing pressures drive demand for outsourced packaging solutions.
AMRI has more than doubled its bulk Active Pharmaceutical Ingredient (API) aseptic manufacturing capacity in response to an increasing need for sterile API and an evolving pharma pipeline, says CCO.
Corning says it is planning to increase manufacturing capacity for its Valor Glass packaging technology to take advantage of a multi-billion dollar industry.
Brammer Bio has completed renovations at its gene therapy manufacturing facility in Cambridge, MA amid industrywide capacity concerns as more biologics enter late-stage clinical trials.
Recipharm says three more of its facilities are equipped and ready for US Drug Supply Chain Security Act (DSCSA) serialisation demands, the deadline for which passes today.
Encouraged by a North Carolina state grant, Fresenius Kabi will expand its prefilled syringes business acquired from Becton, Dickinson and Company in 2016.
The US Food and Drug Administration (FDA) has approved Emergent BioSolutions’ supplemental Biologics License Application (sBLA) for the manufacture of ACAM2000, the only FDA-licensed smallpox vaccine, as the company looks to expand its CMO services.
Peregrine Pharmaceuticals was a biotech company – now, the company is transitioning to a pure-play contract development and manufacturing organization (CDMO) as it sells off its R&D assets.
Pfizer has sold its share of a joint venture with Zhejiang Hisun Pharmaceuticals but will continue supporting the local production of generic drugs in China.
Quotient Clinical unveiled its new identity at AAPS – and today, has announced another acquisition as the company looks to represent “a new class of business,” says CEO.
Recipharm says it will cease manufacturing at sites in Stockholm and Höganäs, citing ‘underperforming operations’ at its package filling and manufacturing-focused sites.
Servier recently announced $7.5m for new technology, is doubling capacity at its Chinese facility, and is investing $58m to support biologics – a few projects among the company's effort to increase productivity as the industry demands a faster time-to-market.
“Small molecule products should be packaged at the location where they are produced,” says Roche, which is laying-off 235 jobs at a packaging plant in Switzerland.
Heavy investment in quality control, quality assurance and dedicated equipment is likely to keep CAR T-cell manufacturing in-house, says Juno Therapeutics.
Pfizer has attributed a 12% operational decline from its sterile injectable products on “capacity constraints and technical issues” stemming from former Hospira facilities.
Sponsors using a single-source outsourcing partner could potentially save up to $45m through reduced time to market, according to a recent Tufts study.
The new Changzhou, China-based site adds transition metal catalyst-screening technology to STA’s small molecule process development and manufacturing platform.
Drug firms need excipients suited to continuous manufacturing according to Dow, which says a better understanding of how products perform when used in round-the-clock production is required.
Sartorius Stedim Biotech (SSB) has cut its full year guidance, citing the negative impact of hurricane Maria, customer destocking and ongoing issues with a cell culture media supplier.
Chiome Bioscience has selected ProBioGen to develop and manufacture its monoclonal antibody LIV-1205, which is designed to combat liver cancer and solid tumours.
Recipharm has installed serialization technology at its contract production facility in Lisbon, Portugal citing impending US and EU rules as a driver for the investment.
Pharmaceutical companies are more likely than their suppliers to cite cost improvement over time as the most effective metric for measuring supplier performance, according to a recent report.
Back-up generators and secondary manufacturing sites limited the supply and financial impact of Hurricane Maria across J&J’s Puerto Rican pharma facilities, the firm says.
Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.
Around half the products made at the Broomfield facility will be discontinued or divested says Novartis, blaming increased US generics competition and customer consolidation for the closure.
