Final guidance on the cooperative manufacture of licensed biologics has been issued by the FDA, which gives companies an outline of how to share responsibilities through the production process.
Research into developing manufacturing methods to produce cheap antiretrovirals in Africa has been highlighted on World Aids Day by The Council for Scientific and Industrial Research (CSIR).
Domino Printing Sciences chose this year’s Emballage world packaging exhibition in Paris, France to showcase the new 5” printhead it has developed for its V300+ thermal transfer printer.
Sepha has launched PakScan, its new leak testing machine that the company claims can quickly and non-destructively test for holes in sachets and sealed pouches.
Contract research group Recipharm has leased AstraZeneca Biotech Laboratory (ABL) in Sodertalje, Sweden, bolting on recombinant protein and monoclonal antibody development capabilities to its offering.
Merck Serono has begun work on the expansion of its Swiss biotech facility, with the additional capacity being used to meet rising demand for Erbitux (cetuximab).
The new MabDirect MM Fixed D column, launched by Denmark’s Upfront Chromatography, could be a boon for CMO’s and pilot plants working in the expanding bio-processing sector.
Following Barack Obama’s victory in the race to the White House, in-PharmaTechnologist.com examines what this could mean for the pharmaceutical industry.
Disposable bioreactor specialist Wave Biotech AG of Switzerland has been snapped up by its commercial and development partner Sartorius-Stedim for an undisclosed sum.
Taiwan’s efforts to position itself as a major biotechnology hub received a further boost today with the opening of Merck KGaA’s dedicated technology training centre in Xizhi City, Taipei County.
API maker Cody Laboratories is targeting the lucrative analgesic and pain management markets with a new process that improves the efficiency of hydromorphone and hydrocodone manufacture.
BioVigilant says that two type V DMFs for its IMD-A rapid microbial detection system, which it has filed with the US FDA, can now be referenced by clients hoping to use it in drug manufacture, potentially reducing review times.
Ahead of the “open house” at its facility in Monteriggioni, Siena, Italian machining specialist Marchesini spoke with in-PharmaTechnologist.com about the new plant and its role in the firm's offering to the drug industry.
Alcan says that its new Indian facility further strengthens its position “in pharmaceutical flexibles through growth in emerging markets,” which contributed about 20 per cent of its revenue last year.
Pfizer is shifting its research focus to those diseases where its sees the potential for the biggest treatment improvements and profits, while dropping eight disease areas including cholesterol.
French firm Novasep has significantly boosted its ability to provide customers with enantiomerically pure compounds with the addition of a new chiral chromatography unit.
Prosonix, a specialist developer of ultrasonic industrial processing solutions, says that global drug giant Pfizer is to begin using its Prosonitron reactor and sonocrystallisation technology at its manufacturing facility in Ireland.
EnWave says that its freezeREV dehydration technology can reduce the moisture content of single vial vaccines to between 3 and 3.5 per cent, bettering the mark achieved by its bioREV platform.
Oral dose filling specialist Capsugel hopes that its new Xcelohood containment system will improve industrial weighing operations during the preparation of high-potency drugs.
The FDA has issued generics giant Ranbaxy Laboratories with two warning letters, detailing “extensive deviations from US cGMP requirements” at the firm’s manufacturing plants in Dewas and Paonta Sahib, India.
Bilcare GCS, the clinical supplies arm of Indian packaging giant Bilcare, has considerably expanded its Phase III trial offering in an effort to provide drugmakers with a complete package.
Artelis president Jose Castilo believes that the record MAb yield from CHO cells grown in its iCELLis bioreactor shows the platform could shift the paradigm for the "production of recombinant proteins.”
in-PharmaTechnologist.com's latest round-up of developments in pharmaceutical manufacturing features news of the world’s “biggest pharmaceutical allergen production unit”, Lentigen’s relocation and a cytotoxic robot.
APP Pharmaceuticals has bought additional facilities at a site in Grand Island, New York seizing the opportunity created by Astellas Manufacturing’s decision to shift production of its dermatitis drug Protopic to Japan.
Speculation is rife that Australia’s Amcor is one of several companies to have tabled bids for Rio Tinto’s $4.4bn (€3.1bn) Alcan Packaging division that serves the pharmaceutical, food and tobacco industries.
The FDA has granted sNDA approval for Akorn’s IC-Green injection dye, which is the first lyophilised product manufacturered at the firm’s Decatur facility to gain such status.
in-PharmaTechnologist.com’s latest round up of products launched in the pharmaceutical manufacturing sector includes new offerings from Genevac, Lock and AdvantaPure.
UK and Swedish researchers have developed a system that eliminates the need for antibiotics and resistance genes in the engineering of biopharmaceutical products, making the process both safer and less costly.
UK-based polymer technology specialist Chromatide and Akzo Nobel's Separation Products (SP) unit are teaming to develop a HPLC media for purification applications in the drug manufacturing industry.
Conformia says that the integration of its SOA data platform into IBM’s system will provide drugmakers with robust management architecture for the entire lifecycle of a product.
An increase in the sale of vaccines such as Quinvaxem and Epaxal, helped Dutch drugmaker Crucell reduce its loss some 56 per cent to €7.9m ($12.5m) in the second quarter.
in-PharmaTechnologist.com's round-up of developments in pharmaceutical manufacturing features news of SAFC’s new highly potent API plant, ISPE’s Facility of the Year Awards and Israel’s proposed entry into PIC/S.
in-PharmaTechnologist.com’s latest round up of developments in the field of pharmaceutical packaging includes 3S’ counterfeit solution and new machines for Xcelience and Medica.
in-PharmaTechnologist.com’s latest round up of products launched in the pharmaceutical manufacturing sector includes new offerings from Millipore, Sensor Products and Aspex.
Lonza hopes that the new business it has set up in China will help cement its position as a leading provider of services to the country’s pharmaceutical manufacturing sector.
In response to high customer demand, leading automated chemistry systems manufacturer Syrris is now offering to build custom-made laboratory reactor systems designed to meet individual customer needs.
Bio-Rad has published several application notes describing the use of its Profinity eXact protein expression system to obtain tag-free native proteins from a cell lysate in less than an hour.
R&D integration specialist Symyx Technologies says its Powdernium Workstation is integral to the new automated dry powder dispensing system developed by a "major" but as yet unidentified pharmaceutical company.
in-PharmaTechnologist.com's round-up of developments in the pharmaceutical manufacturing space features news of a fire at MY Healthcare, Helsinn's FDA approval and a safety award for Wyeth.
Roche’s proposed $44bn acquisition of Genentech is facing some opposition with Wall Street saying the offer undervalues the company, disquiet among the biotech’s employees and shareholders suing the Swiss giant.
Designed as a next generation cellulose-based virus removal filter, Planova™ S20N has demonstrated robust filtration performance for challenging molecules...
Bispecific antibodies (BisAbs), which can bind to two distinct antigens, are prone to high levels of aggregate (10-30%), challenging traditional platform...
Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...