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ATMI Opens US Bio Development and Testing Lab

ATMI Opens US Bio Development and Testing Lab

17-Jun-2013 - ATMI has opened a development and testing lab in the US to let customers test its single-use production and technologies.

Lonza Launches New Safety and Manufacturability Service for Biologics

Lonza Launches Combined Safety and Manufacturability Service for Biologics

13-Jun-2013 - Lonza has launched a service to help biopharmas decide if promising protein drug candidates are worth developing, from an immunogenicity and manufacturing standpoint.

Is Pharma Excommunication Discouraging Potential Whistleblowers?

13-Jun-2013 - Pharma employees who report manufacturing misconduct to stop adulterated drugs getting to market put their careers at risk and face being blackballed by industry says an American advocacy group.

B-I says Chinese JV Could Elevate Domestic Manufacturing Industry

B-I says Chinese JV Could Elevate Domestic Manufacturing Industry

10-Jun-2013 - Boehringer Ingelheim will build a biomanufacturing facility in Shanghai in a strategic alliance designed to cater for Pharmas nervous about setting up plants in China.

Cali Plant Remediation 'Impax' 110 Jobs, Mostly Manufacturing

06-Jun-2013 - Impax Laboratories says it remains committed to resolving manufacturing issues at its troubled Californian plant though 110 jobs will go as production continues to be transferred to Taiwan. 

Industry-Led Biosciences Centre to Target Global Diabetes & Obesity in Indiana

05-Jun-2013 - The state of Indiana has unveiled a new industry-led Biosciences Research Institute though it is unclear how companies will divide intellectual property and product patents.

Propofol Off FDA List but Manufacturing Issues Cause 75% of Shortages

04-Jun-2013 - 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.

CorePharma: GMP Confident, Ready to Relaunch After FDA Closeout Letter

03-Jun-2013 - Three years after receiving a warning letter for GMP violations, CorePharma says it is in a full state of compliance and ready to relaunch products.

DISPATCHES FROM INTERPHEX

Thermo Fisher: Single-Use Tech's Evolution and Increased Industry Use

29-May-2013 - Over the last decade single-use technologies have moved into manufacturing scales and are increasingly being deployed worldwide, according to Thermo Fisher Scientific.

Cobra's Cell Line Development Tech Bags Recopharma Contract

29-May-2013 - 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.

Voluntary Drug Recalls from Fresenius, J&J and Glenmark

28-May-2013 - 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.

Sinovac Receives Updated cGMP Accreditation from CFDA

28-May-2013 - Vaccine manufacturer Sinovac has updated its GMP accreditation to international standards, short of the deadline set by the CFDA.

Malaysia's Pharmaniaga Targets MENA Region with Saudi J-V

27-May-2013 - Pharmaniaga Berhad has set up a joint venture to manufacture pharmaceuticals in Saudi Arabia citing opportunity growth in the region as a major catalyst.

Bioartificial Liver Project Looks to Disposable Bioreactors for Large Scale Cultures

22-May-2013 - 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.

Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing

21-May-2013 - 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.

News in brief

Hikma is Latest Firm to Stop Drugs Being Sold for Lethal Injections

20-May-2013 - Hikma has become the latest injectable manufacturer to take measures to stop its drugs being used in lethal injections.

Janssen's Manufacturing Problems May Lead to Criminal Charges in Korea

20-May-2013 - Though Janssen Korea says it is confident it will resolve its manufacturing issues, product recall and suspensions could be followed by lawsuits and imprisonment.

Dispatches from Interphex

EMD Millipore Talks New Single-Use Chromatography Tech

20-May-2013 - EMD Millipore says its new chromatography tech can help manufacturers avoid compromising their processes when switching from multi-use to single use

Pfizer Puts Lipitor Site Up For Sale as Patent Expiration Causes Over-Capacity

16-May-2013 - Lower sales of off-patent former blockbuster Lipitor have prompted Pfizer to try and sell off its third Irish API plant in as many years. 

ATMI: Single-Use Could Replace Multi-Use, as Potency Increases
DISPATCHES FROM INTERPHEX

ATMI: Single-Use Could Replace Multi-Use, as Potency Increases

15-May-2013 - Single-use is set to dominate biopharma processing as products become more potent resulting in smaller volumes, according to ATMI.

Another US Plant Closure in Cost-Saving Plan as Teva Eyes Head 'East'

07-May-2013 - Teva will close a second US plant and shift manufacture to more cost effective facilities as part of its company-wide restructuring programme.

Novartis to Cut 300 Jobs in OTC Plant Restructuring After Form 483

06-May-2013 - 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.

News in brief

Novo Nordisk $69m Plant Conversion For New Diabetes Drug

06-May-2013 - 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.

LIVE FROM INTERPHEX

Customers to Save up to 65% as ASI and Chromatan Pen Single-Use Deal

30-Apr-2013 - 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.

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

30-Apr-2013 - 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.

Spotlight

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients
Dispatches from Excipient Fest in Baltimore - UPDATE

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients

As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and...

China Looks to Tighten Excipient Regulations with Limited Resources
Dispatches from Excipient Fest in Baltimore

China Looks to Tighten Excipient Regulations with Limited Resources

China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have...

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax...

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020...