Processing equipment

GEA and Siemens team on continuous processing tech

17-Jan-2017 By Gareth Macdonald

Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.

Aerie to build manufacturing facility in Ireland

11-Jan-2017 By Dani Bancroft

Aerie Pharmaceuticals Inc will lease a 30,000 sq ft manufacturing facility in Ireland to commercialise its eye-drop product for Glaucoma after delays at a third party CMO.

T-ray technique faster for tablet quality and structure testing say researchers

11-Jan-2017 By Gareth Macdonald

High frequency radiation can be used to test tablet quality and structural characteristics on the production line according to scientists planning to develop low cost THz sensors.

US DEA finalises controlled substance and equipment revisions

09-Jan-2017 By Dan Stanton

Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.

CytoBioscience buys formulation safety tech company in Alabama for millions

22-Dec-2016 By Staff Reporter

Cytobioscience Inc, has acquired Soluble Therapeutics Inc to expand its high throughput formulation screening capabilities.

DuPont gets Gates grant for protein drug production platform

20-Dec-2016 By Gareth Macdonald

DuPont has joined a Gates Foundation backed effort to develop low cost production methods for therapeutic proteins.

Cipla to make drugs in Iran in deal with Ahran Tejarat

15-Dec-2016 By Gareth Macdonald

Cipla Ltd has formed a joint venture with Ahran Tejarat Company to manufacture and sell drugs in Iran.

GSK extends single-use purification tech R&D deal with Puridify

06-Dec-2016 By Dan Stanton

The development partnership has been extended as GlaxoSmithKline looks to make clinical trial scale batches using Puridify’s Protein A alternative to packed bed chromatography columns.

Takeda to build €40m Irish plant for global Ninlaro API supply

05-Dec-2016 By Dan Stanton

Takeda will build a high containment production facility at its site in Dublin, Ireland to support the manufacturing of its oncology product Ninlaro (ixazomib).

Operator silence rings alarm bells during audits, say FDA and WHO experts

01-Dec-2016 By Dan Stanton

Full transparency and open conversation with operators will lead to more successful facility audits, say regulatory experts.

Takeda building Dengue fever vaccine plant

01-Dec-2016 By Gareth Macdonald

Takeda has started work on a vaccine plant to make its candidate Dengue fever virus vaccine, TAK-003.

Spain's Idifarma adds capsule filling to service offerings

01-Dec-2016 By Dan Stanton

Idifarma has invested over €300,000 in its facility in Spain in order to offer its customers automated capsule filling for commercial batches.

update

ICH completes draft Q11 implementation Q&A; welcomes ANVISA and MFDS

29-Nov-2016 By Gareth Macdonald

The ICH has put together a draft Q&A document to clarify Q11 guidelines on drug active ingredient production.

Catalent adding OTC capsule maker Accucaps to global softgel network

28-Nov-2016 By Dan Stanton

Catalent will add two Canadian manufacturing facilities to its softgel network through the acquisition of Accucaps.

Pfizer axes parts of $425m Irish expansion after dropping PCSK9 inhibitor

28-Nov-2016 By Dan Stanton

Plans to build a five-story biomanufacturing plant in Ireland could be shelved following the clinical failure of Pfizer's proposed cholesterol-lowering candidate bococizumab.

Sanofi Pasteur confirms plant problems prompted TheraCys decision

22-Nov-2016 By Gareth Macdonald

Sanofi Pasteur has confirmed the decision to stop making the bladder cancer drug TheraCys was prompted by long running problems at the Toronto manufacturing plant where it is made.

AAPS 2016

Continuous and aseptic innovations top FDA list of emerging tech requests

21-Nov-2016 By Dan Stanton

Continuous manufacturing and sterile production innovations have dominated requests to participate in the US FDA’s Emerging Technology programme, the Agency says.

Both small and large CMOs to benefit from pharma capacity and agility demands

21-Nov-2016 By Dan Stanton

Larger CMOs are likely to be better for commercial manufacturing but small players offer niche services and agility for lower volumes, say Symbiosis and Idifarma.

DISPATCHES FROM AAPS 2016

Pfizer and FDA: Expedited regulatory pathways ignore manufacturing burdens

15-Nov-2016 By Dan Stanton

The flexibility of clinical development for products on designated accelerated pathways is leading to at-risk investments in commercial manufacturing, say Pfizer and the FDA.

Thermo provides hot-melt tech to US continuous manufacturing researchers

14-Nov-2016 By Gareth Macdonald

Thermo Fisher Scientific has provided Rutgers’ researchers with hot-melt extrusion tech to support development of continuous manufacturing for drug production.

Hurricane and fire related shutdowns have cost Patheon $15m in lost revenue in Q4

14-Nov-2016 By Dan Stanton

Recent facility closures due to a hurricane and a power outage have cost Patheon around $15m in lost revenues, the firm says.

Slovakian CDMO Saneca ups capabilities after controlled release contract win

10-Nov-2016 By Staff Reporter

Saneca Pharma will invest in its manufacturing site in Slovakia to service a five-year agreement supplying the Menarini Group with controlled release pellets.

Pfizer closing two UK manufacturing plants: 370 jobs at risk

09-Nov-2016 By Dan Stanton

Pfizer has earmarked two sites in the UK for closure, including an ex-Hospira aseptic plant in London it says would need ‘significant investment’ to remain open.

Datwyler injects CHF 100m into US drug delivery component site

03-Nov-2016 By Staff Reporter

Increasing demand for reduced particle loads in pharmaceutical containers has driven Datwyler to build a CHF 100m plant making elastomer components for injectable drug delivery systems.

Recipharm invests €1.2m in Italian small-scale API capabilities

02-Nov-2016 By Dan Stanton

Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.

Agilent developing new applications for mass spectrometry system

01-Nov-2016 By Melissa Fassbender

Agilent Technologies has contracted the original creators of its RapidFire 365 High-throughput Mass Spectrometry System to further develop new applications.

Thermo Fisher confident in gaining share of blossoming Korean market

01-Nov-2016 By Staff Reporter

South Korea is a key opportunity for biopharma services firms says Thermo Fisher, reporting its third quarter which saw it up capabilities in the region.

BASF upping cost of ethanolamines by €100 per tonne in Europe

31-Oct-2016 By Dan Stanton

BASF will increase the European sales prices for its ethanolamines by €100 ($110) per metric ton due to the rising costs of the raw material.

Patheon contracted to make second drug by age-related diseases firm Biophytis

25-Oct-2016 By Gareth Macdonald

Patheon will make a candidate AMD treatment under a contract with French biotech Biophytis.

UK processing training centre to boost pharma manufacturing sector

18-Oct-2016 By Dan Stanton

A newly opened training centre in Leeds, UK will help fulfil demand for skilled workers in the drug production space, says the head of process manufacturing.

Roller compactor bolsters Juniper's granulation capabilities

17-Oct-2016 By Staff Reporter

CDMO Juniper Pharma Services has added a small-scale roller compactor as the latest investment in its enabling technology offerings.

Patheon Q4 likely to suffer from hurricane-related plant closures

17-Oct-2016 By Dan Stanton

Two manufacturing facilities were closed after being hit by Hurricane Matthew earlier this month, according to a Patheon SEC filing.

Danaher set to buy purification consumables firm Phenomenex

12-Oct-2016 By Dan Stanton

Danaher Corporation will further extend its presence in the life sciences space through the acquisition of separations and purification firm Phenomenex.

Merck opens testing plant in latest Korean bioprocessing investment

07-Oct-2016 By Dan Stanton

Germany’s Merck has opened a bioprocessing collaboration centre in Songdo, Incheon - the latest investment supporting the burgeoning Korean biopharma industry.

Dispatches from CPhI

Continuous manufacturing: pharma adoption challenges remain according to CMAC

06-Oct-2016 By Gareth Macdonald

Economics, regulatory inexperience and a lack of technical skills are holding back drug industry adoption of continuous manufacturing says CMAC industrial director, Craig Johnston.

Novo Nordisk: manufacturing jobs safe amid cost-cutting measures

03-Oct-2016 By Dan Stanton

The loss of 1,000 jobs is the latest cost-cutting initiative from Novo Nordisk but no manufacturing positions are at risk, the firm says.

AbbVie API plant opens in Singapore as first part of larger $320m site

29-Sep-2016 By Dan Stanton

AbbVie has opened an oncology and women’s health API plant, part of its planned 120,000m2 small and large molecule manufacturing site in Singapore.

US FDA: Cheng Fong Chemical must do more to investigate complaints

28-Sep-2016 By Gareth Macdonald

Cheng Fong Chemical has addressed problems at its Taoyuan City plant but still needs to identify the source of foreign matter found in its APIs according to the US FDA.

UPDATE

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