Breaking News on Contract Research, Manufacturing & Clinical Trials

ADC Bio Expands Lab Services in Response to Demand

21-May-2013 - ADC Biotechnology says demand for antibody drug conjugates (ADC) services has skyrocketed as it receives a second financial boost to development in four months. 

News in brief

Almac & UCL Team Up on Enzyme Discovery

21-May-2013 - Almac says the joint programme with UCL will complement its partnership with DSM and increase its biocatalysis offerings.

Dispatches from Interphex

TFS Sees Increase in Modularization, Shorter Construction Timelines

21-May-2013 - 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.

Cobra Confident of Commercial Vaccibody Contract

Cobra Confident of Commercial Vaccibody Contract

20-May-2013 - 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.

West Adds Second Filling line in Prep for Future Crystal Zenith Boom

15-May-2013 - 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.

Dedicated Analytical Expansion Could Target New Clients, says Kemwell

15-May-2013 - Kemwell says expansion of its Indian analytical services will service a major client but is part of an active growth strategy.

Wuxi Manufacturing Services Help Increase Quarterly Earnings

15-May-2013 - Better than expected growth in Wuxi’s manufacturing services has driven the CRO to exceed its earlier guidance in the first quarter of 2013.

Aesica teams with Academics on Amide Bond tech

Aesica Accesses Atom-Efficient Amide Tech in Academic Accord

14-May-2013 - 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 Drives AMRI Q1 Revenue Uptick

14-May-2013 - 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. 

US Varicose veins a revenue stream for SCM?

SCM Named Commercial Supplier in Varisolve NDA

14-May-2013 - 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.

Recipharm to offer new metal-based delivery tech

13-May-2013 - 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.

FDA: Foreign Manufacturers to Help Alleviate US Infant Drug Shortages Next Week

10-May-2013 - 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...

BASF and Chemport Get US FDA OK as Amarin Suppliers

BASF and Chemport Get US OK as Amarin API Suppliers

07-May-2013 - API makers Chemport and BASF have been cleared by US regulators to supply Amarin with omega-3 for its heart drug Vascepa.

Hospira says Troubled Plant on 'Rocky' Road to Recovery

06-May-2013 - 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.

Live From Interphex in New York City - Updated

AMRI Exec Discusses 'New Bar' in FDA Enforcement

02-May-2013 - 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...

Goodwin

Demand Across Biopharma Drives Goodwin and Coldstream ADC Partnership

02-May-2013 - Goodwin Biotechnology has teamed up with Coldstream Laboratories to offer clients ADC services as another example of biopharma demand driving contract manufacturing and development.

Lonza Closes Ireland Site as US Manufacturing Issues Cause Increlex Shortage

30-Apr-2013 - 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...

News in brief

Catalent Quadruples Biologics Services with Opening of New plant

30-Apr-2013 - The ribbon has been cut on Catalent’s new single-use biomanufacturing Centre of Excellence which will quadruple its current offering.

AstraZeneca Cooperating with Manufacturing Questions from US DOJ District Attorney

29-Apr-2013 - 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. 

Live from Interphex

Experts: Real-Time Release Testing Desirable But Not Primary Goal of QbD

24-Apr-2013 - The US FDA is beginning to push CMOs and other manufacturers away from using real-time release testing as a shortcut to ensuring drug quality and reducing end product testing, experts...

DSM Opens Australian Government Backed Biologics Facility

24-Apr-2013 - With backing from the Australian Government, DSM has opened a mammalian cell culture operation to fuel the growing demand in the Asia-Pacific biologics market.

Fujifilm's Cell Banking Facilitates "Larger Slice" of Biologics Pie

23-Apr-2013 - Third-party manufacturers of biologics are seeing increased demand but more short term contracts, according to Fujifilm.

US FDA Seeks Help in Selecting High-Risk Manufacturing Facilities for Inspections

23-Apr-2013 - The cash-strapped FDA is looking to cut corners any way it can, especially if it can hone in on which pharma manufacturing facilities and sites need to be prioritized for...

Baxter Evaluates Biomanufacturing at New Minnesota Plant

23-Apr-2013 - Baxter says it is evaluating a number of options at its newly acquired Minnesota facility, though biosimilars will be the main focus.

Biologics Contracting Demand Drives Cytovance Expansion

22-Apr-2013 - Cytovance Biologics is once again expanding its manufacturing capabilities as CMOs compete to keep up with pharma’s growth rate in biologics.