As propofol comes off its shortages list, the FDA says manufacturing problems still cause the majority of supply issues though legislation has helped to alleviate this.
Over the last decade single-use technologies have moved into manufacturing scales and are increasingly being deployed worldwide, according to Thermo Fisher Scientific.
As Cobra wins a cell line development contract with Recopharma, the firm says its cost-effective gene expression technology has been its biggest growth area.
Although written quality agreements are not required under cGMP regulations, the US FDA is recommending that pharma companies and CMOs adopt the agreements to delineate responsibilities.
Fresenius Kabi says drug shortages won’t be affected as it recalls a lot of magnesium sulphate, and there’s news from Glenmark and J&J – welcome to in-Pharmatechnologist.com's recall round-up.
Pharmaniaga Berhad has set up a joint venture to manufacture pharmaceuticals in Saudi Arabia citing opportunity growth in the region as a major catalyst.
GlaxoSmithKline (GSK) says some manufacturing from the shuttering of an Australian packaging site will be picked up by Aspen and local third-party contractors.
Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure.
Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.
Boehringer-Ingelheim’s German API and pharmaceutical manufacturing facility was cited by the FDA for two API and two drug cGMP violations, as well as failing to respond with sufficient corrective actions after the first Form 483.
Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.
Biopharma companies are looking for more pre-fabrication of their facilities and to be able to expedite construction and meet tighter timelines, an expert told Outsourcing-Pharma.com.
ADC Biotechnology says demand for antibody drug conjugates (ADC) services has skyrocketed as it receives a second financial boost to development in four months.
Though Janssen Korea says it is confident it will resolve its manufacturing issues, product recall and suspensions could be followed by lawsuits and imprisonment.
Cobra Biologics is confident it can win the commercial contract for Vaccibody AS’ candidate DNA vaccine, citing its production platform and recent capacity expansion as key.
Extra filling capacity is to be made available in preparation for West’s Crystal Zenith (CZ) system, though approval and increased sales are still at least 18 months away.
Varicose veins could prove to be a big revenue stream for UK CMO SCM Pharma which has been named as commercial supplier for BTG’s candidate treatment, Varisolve.
Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.
Large scale manufacturing contract revenue in the first quarter of 2013 increased 14% over the same quarter in 2012 as AMRI (Albany Medical Research Inc.) saw an 11% increase in overall revenue.
Melding metals to APIs could make drugs easier to deliver according to Sweden's Recipharm which partnered to add a new chemistry to its offering last week.
Continued manufacturing issues at both American Regent and Hospira have caused the US FDA to begin allowing foreign imports as early as next week to combat a shortage of critical drugs for infants, the agency told us.
Novo Nordisk says the $69 investment in its Danish plant will convert capacity ready for its new GLP-1 analogue and is a further commitment to Danish manufacturing.
Novartis says both its Swiss plant and third-parties will support its consumer health lines as it restructures its Nebraska facility following a FDA Form 483.
Manufacturing problems and costs associated with a new device-focused strategy hurt in Q1, but Hospira says efforts to fix troubled Rocky Mount facility are still on track.
Goodwin Biotechnology has teamed up with Coldstream Laboratories to offer clients ADC services as another example of biopharma demand driving contract manufacturing and development.
Following the completion of remediation efforts to deal with an FDA warning letter, Chris Phillips, AMRI's senior director of its Burlington, Massachusetts site, discusses what he considers to be a "new bar" in enforcement activity from...
ASI has teamed up with Chromatan in order to deliver single-use and column-free capture purification services which could save clients 65% in chromatography costs in clinical manufacturing.
International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020 policy, according to statements at this year’s BIO International Convention.
Manufacturing disruptions at Lonza's Hopkinton, Massachusetts site are causing shortages of Ipsen Biopharmaceuticals’ growth failure treatment for children in both the US and EU, just as the company announces that it will shutter another manufacturing...
Purification bottlenecks, integrating single-use technologies and low cost companies are just some of the issues affecting the biotech industry today, according to experts at this year’s Interphex.
The US Department of Justice’s Attorney’s Office in Boston has sent subpoenaed documents related to AstraZeneca's UK manufacturing practices, which the company said it is complying with.
