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Biotrinity 2016

UK fully supportive of complex pharma manufacturing, George Freeman MP

28-Apr-2016 - Precision pharmaceutical manufacturing is crucial to the UK’s economy, according to life science minister George Freeman MP.

Live from Interphex: VR, processing tech and manufacturing innovation

27-Apr-2016 -   [View the story "Live from Interphex 2016" on Storify]

Dispatches from Interphex

Fette Compacting unveils first capsule filling machine at Interphex

27-Apr-2016 - Fette Compacting has unveiled its first capsule filling machine, which is capable of outputting 400,000 capsules per hour – a new record in the industry.

3D printing can save drug manufacturers time and money says UK expert

26-Apr-2016 - 3D printing can make drug production simpler and cheaper according to a UK expert who says using it for commercial production is about “numbering up” not scaling up.

Novartis aims to save $1bn by 2020 with integrated manufacturing plan

26-Apr-2016 - The savings will come from centralising manufacturing services and will complement the firm’s cost-saving business division launched last year.

Exclusive Q&A

Breaking barriers: Can continuous manufacturing prevail despite hurdles?

26-Apr-2016 - Regulations, recruitment and facility refits are holding continuous manufacturing back, but a Rutgers’ associate behind J&J’s recent success believes industry can overcome these hurdles.

Novo Nordisk €100m expansion to add 250 jobs in France

21-Apr-2016 - Novo Nordisk has announced plans to expand an insulin production site in France in the latest investment in its manufacturing network.

Rutgers leading continuous manufacturing guidance efforts

J&J success will spur pharma's shift to continuous manufacturing, Rutgers

21-Apr-2016 - Industry will be encouraged to adopt continuous manufacturing methods following the regulatory success of Janssen’s Prezista, says Rutgers University associate director and Interphex speaker Doug Hausner.

Single-use and Stainless steel: Hybrid technologies the future of drug production says expert

20-Apr-2016 - Single-use is the future but stainless steel bioreactors will always play a role in drug production says an expert, who thinks firms could do worse than consult a CMO before deciding in which technology to invest.

Use of a comparability protocol will aid post-approval CMC changes, US FDA

20-Apr-2016 - The US FDA has published draft revisions to a thirteen-year old CMC guidance it says will increase the flexibility of post-approval changes for drugmakers.

Continuous or not? Janssen cites inventory benefits of new Prezista process

19-Apr-2016 - Janssen says the new US FDA-approved production method for its HIV drug Prezista is more efficient and will help it better control inventory.

News in brief

Alembic Indian plant hit with US FDA Form 483 and four observations

19-Apr-2016 - The US FDA has hit an Indian formulation facility run by Alembic Pharmaceuticals with a Form 483 with four observations.

Braeburn in talks with other states as anti-LGBT law puts $20m NC plant on hold

14-Apr-2016 - Several US states have approached Braeburn Pharmaceuticals after the firm said it was reassessing plans to invest $20m in North Carolina following the passing of ­House Bill 2.

Redx to move HQ and development ops to ex-AstraZeneca site in Cheshire

14-Apr-2016 - Redx Pharma has announced plans to set up a development facility and new headquarters in Alderly Park, Cheshire.

Janssen working on other continuous processes post US FDA OK for Prezista

13-Apr-2016 - Janssen is already working on continuous manufacturing methods for other drugs says Rutgers University which helped develop the new Prezista production process approved by the US FDA.


Will North Carolina 'Bathroom Bill' drive pharma away?

07-Apr-2016 - Anti-LGBT legislation has prompted Braeburn Pharmaceuticals to reassess plans for a $20m facility in North Carolina, but will others in "the nation’s number one state for biomanufacturing" follow suit?

Lilly takes to continuous manufacturing with $40m Irish investment

06-Apr-2016 - Eli Lilly will pump €35m ($40m) into a new facility in Ireland focused on the continuous manufacturing of its APIs.

GE and Zenith collaborate on bioprocessing automation

05-Apr-2016 - GE has teamed up with Zenith Technologies to implement automation across its single-use and modular bioprocessing technologies.

Catalent softgel plant hit with US FDA 483 while client Opko receives CRL

31-Mar-2016 - The US FDA says it will not approve Opko's kidney disease drug Rayaldee until contract manufacturer Catalent fixes problems at its softgel plant in Florida.

Revised water for injection monograph allows use of cheaper and greener alternatives to distillation

31-Mar-2016 - The European Pharmacopeia Commission has adopted a revised monograph that allows a broader range of purification methods to be used for the production of water for injectable pharmaceuticals.

To affinity and beyond: Space age flow cytometry tech could aid cell therapy firms says LeukoDx

29-Mar-2016 - Know-how underpinning the tech astronauts use to detect infections in space could streamline cell therapy manufacturing according to new GE Healthcare partner LeukoDx.

Hitachi Chemical licenses PCT tech and mulls cell therapy JV

23-Mar-2016 - Hitachi Chemical has licensed cell therapy manufacturing technology from PCT in a deal that may see the firms set up a European JV.

Affymetrix rejects Origin offer and backs Thermo Fisher merger

21-Mar-2016 - Affymetrix has rejected a $1.5bn rival bid and said it prefers to merge with Thermo Fisher Scientific.

Hovione to build US plant for Vertex's cystic fibrosis drugs

10-Mar-2016 - Hovione and Vertex Pharma have teamed up to set up a continuous manufacturing facility at the former’s site in New Jersey, US.

Life science becoming ‘growth engine’ following Sigma-Aldrich buy, Merck

10-Mar-2016 - Germany’s Merck expects to achieve cost synergies of €90m ($98m) in 2016 from the integration of Sigma-Aldrich which the firm acquired in November.

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