Blockchain provides real-time visibility into the entire clinical trial supply chain and has the potential to solve several of the industry’s biggest challenges.
Messenger RNA is demonstrating success in vaccine manufacturing and CureVac is giving it the place to do so with the development of a prophylactic vaccine with mRNA at its core.
Bernard McGarvey, formerly of Eli Lilly, spoke with us about first principles of engineering in pharma, following his keynote ‘Engineering First Principles Applications to Pharmaceutical Manufacturing.'
Metrics Contract Services’ newly-opened manufacturing site has qualified two commercial bottling lines for serialization with DSCSA requirements set to be enforced this month.
PCI Pharma Services is expanding its clinical site in Rockford, IL – following a string of acquisitions and expansions to help meet an increased demand for services
India-headquartered Glenmark Pharmaceuticals has opened a 100,000-square-foot facility on the East Coast for the manufacture of fixed dose formulations.
Immuno-oncology clinical trials are fundamentally different from traditional oncology studies as it pertains to logistics, and require close coordination across several stakeholders, says CRO.
Tracking the chain of custody for trial kits and ensuring patient data blinding – in compliance with HIPPA and GDPR – are among the unique logistical challenges to direct-to-patient clinical trials.
To manage the supply chain challenges faced by natural disasters, experts say to expect the unexpected – ensuring a strong shipping strategy is in place with temperature control and robust management.
Securing the clinical supply chain comes down to the notion of ‘compliance’, which is transitioning from a ‘nice to have’ to a ‘need to have,’ says Cryoport.
This week in-PharmaTechnologist attended AAPS PharmSci360 in Washington, D.C. where discussions and thought-provoking ideas bounced across sessions – here, we highlight some of the most significant.
Sharp has signed a preferred partnerships agreement with an MA-based CMO to reduce “friction” for clients while decreasing the time, cost, and complexity of managing clinical trials.
With less than one month until the US DSCSA deadline, RAPS member Greg Cathcart says the biggest concern for firms is understanding what is required, and when.
The decision, influenced by the expected loss of exclusivity for Restasis, will allow the company to ‘improve efficiencies’ across its manufacturing network, a spokesperson explained.
CROs this month have made significant new hires with WCG adding eight to its scientific leadership team, PPD hiring four, and BioIVT filling its new-created role of CCO.
Also, making the move from Bioclinica, David Kiger has been named...
Nascent next-generation processing technologies are expected to have a significant effect on how drugs are brought to market – faster and more cost-effectively than ever before, says industry expert.
Aspen will spend a record sum on transforming its Port Elizabeth manufacturing site, marking the ‘single biggest pharmaceutical investment’ in South Africa to date.
AAPS PharmSci 360 is a new conference this year, created in response to a desire for “fresh science,” specifically with chemical and biomolecular components. So what can you expect?
Idifarma’s seventh project with Palobiofarma will see the CDMO provide drug formulation, development and manufacturing services for respiratory disease candidate PBF-2987.
Marken is centralizing its brokerage management services in conjunction with UPS, as the rise in global trials brings more vendors and new challenges into the fold.
CPhI panelists agree that there is going to be significant consolidation in the CDMO space – and express the desire to work with fewer suppliers, the top five of which currently account for 15% of the total market.
Almac has opened a new 24,000 square foot building at its location in Durham, NC to meet demand driven by the rise in biological investigational products, says CDMO.
The 5,000-square-foot expansion responds to client demand, says president Robert Lee: “The market for services is growing, yet the supply of CMOs interested in taking on these complex drug products is not.”
eTheRNA announced it will be opening a cGMP compliant mRNA manufacturing facility in Belgium, to increase production of its three mRNA encoding proteins.
Following stints in Paris and Frankfurt, CPhI Worldwide has again set up in Madrid for three days of insight briefings, biopharmaceutical tracks and networking.
Following a review of its Ulverston site, GSK announced at the end of last week it would shed positions related to the manufacture of active ingredients for sterile injections.
Dr. Reddy’s Laboratories antibiotic manufacturing site in Bristol, Tennessee, has been sold to Neopharma, along with all issued and outstanding membership interests and related assets.
Metrion has bolstered its drug discovery leadership team, CluePoints has upped its RBM services, and Concept Life Sciences has added to its analytical services division, among other moves this month in the outsourced pharmaceutical services industry.
