Processing equipment

Pfizer signs $425m mRNA flu vaccine agreement with BioNTech

20-Aug-2018 By Maggie Lynch

BioNTech signed a collaboration agreement with Pfizer to conduct joint research on a mRNA-based flu vaccine.

Catalent completes Juniper merger to ‘expand and strengthen’ oral dose manufacturing

14-Aug-2018 By Flora Southey

Juniper Pharmaceuticals will become a wholly owned subsidiary of Catalent Pharma Solutions today, says the CDMO.

Mylan aims to ‘reduce complexity’ at Form 483-hit plant

13-Aug-2018 By Ben Hargreaves

In a second quarter call with investors, president of Mylan, Rajiv Malik, stated the company has undertaken a restructuring and remediation plan at its Morgantown, West Virginia plant.

Korea round-up: Janssen exits plant, Bayer transfers manufacturing

08-Aug-2018 By Flora Southey

Janssen has confirmed plans to close a supply chain facility in HyangNam, while Bayer is transferring manufacturing operations from Ansung, South Korea, to Berlin, Germany.

Fukoshima-based API maker receives US FDA warning over unreported data

02-Aug-2018 By Flora Southey

Unreported electronic data and a lack of review criteria and methodology were cited in the US FDA warning letter.

GSK closes Bangladesh manufacturing plant, sheds 1,000 workers

31-Jul-2018 By Maggie Lynch

GSK is shutting down its Bangladesh manufacturing plant in an effort to streamline its emerging market operations, laying off 1,000 employees in the process.

ACG becomes India’s first in-house packaging provider for oral solid meds

26-Jul-2018 By Ben Hargreaves

ACG has expanded its capabilities by completing its work on a lamination facility to be able to complete all packaging requirements for solid oral medication in-house.

Cobra, Pfizer, GE Healthcare safe in Sweden fires

25-Jul-2018 By Flora Southey

The dozens of ‘devastating, unprecedented and dangerous’ forest fires raging across Sweden are far from manufacturing and industrial centres, says Swedish Association of the Pharmaceutical Industry.

Cambrex enters finished dosage market with $425m Halo Pharma acquisition

23-Jul-2018 By Flora Southey

API maker Cambrex Corporation will add drug development and finished dosage capabilities to its network with the acquisition of CDMO Halo Pharma.

Novartis seeks out-licensing partners as it exits antibiotics R&D

17-Jul-2018 By Flora Southey

Novartis says it will discontinue antibacterial and antiviral research to free-up resources for core focus areas.

Wasdell gets serialisation-ready ahead of EU and US deadlines

13-Jul-2018 By Staff Reporter

Wasdell Group has launched a serialisation service, with optional three-tier aggregation, ahead of EU and US implementation deadlines.

Sanofi halts manufacturing amid pollution claims at French plant

12-Jul-2018 By Flora Southey

Sanofi has suspended production at a French manufacturing facility it says released solvents into the atmosphere.

PA to NJ: Teva accepts $40m tax savings to relocate US HQ

09-Jul-2018 By Flora Southey

Teva says relocating US headquarters from Pennsylvania to New Jersey is part of its “significant restructuring plan.”

NEWS IN BRIEF

ChargePoint reports 399% growth in China

04-Jul-2018 By Flora Southey

After announcing expansion plans across the Americas, ChargePoint says it is growing its presence in Asia.

Catalent eyes early-phase work with $133m Juniper acquisition

03-Jul-2018 By Melissa Fassbender

Catalent is set to acquire Juniper Pharmaceuticals in a $133m deal, which will provide the CDMO with a new European hub and the ability to win a larger share of early-phase development programs says exec.

NEWS IN BRIEF

Orion signs VagiVital commercial supply deal, oversees tech transfer

21-Jun-2018 By Flora Southey

Orion Contract Manufacturing will make, package, and supply Peptonic Medical’s over-the-counter VagiVital product, which is set to launch later this year.

Adents launches NovaTrack: 'Blockchain will help secure certain parts of track and trace'

20-Jun-2018 By Flora Southey

Adents has combined artificial intelligence and Microsoft Blockchain-based technology to help secure and analyse transactions across the supply chain.

Recipharm buys Sanofi CMO site in UK, signs long-term supply deal

18-Jun-2018 By Flora Southey

Sanofi is handing off its Holmes Chapel facility and all existing contract manufacturing agreements to CDMO Recipharm.

WuXi STA: China approves first CMO-made new drug

14-Jun-2018 By Flora Southey

The first candidate made in accordance with China’s Marketing Authorisation Holder pilot programme has received new drug application approval.

NEWS IN BRIEF

Alcami supporting commercial supply of Flexion’s first FDA-approved product

13-Jun-2018 By Melissa Fassbender

Alcami began work on Flexion Therapeutics's ZILRETTA in the fall of 2014 and today announced that it will further support commercial supply of the product, which is approved for the treatment of OA-related knee pain.

FUTURELINK 2018

Serialisation legislation could improve recall process for drugmakers, says exec

13-Jun-2018 By Flora Southey

Impending EU serialisation regulations could enhance drug recall procedures for pharmaceutical companies, says executive.

Cambrex expands in Italy and Sweden: New hires, labs to be ready in 2019

13-Jun-2018 By Melissa Fassbender

Cambrex’s news that it will be constructing a research and development laboratory at its Italy-based site follows on the heels of its recently announced plans to begin a $5m expansion in Sweden.

FUTURELINK 2018

Blockchain the perfect fit for digital supply chain? Industry not convinced

11-Jun-2018 By Flora Southey

Blockchain is gaining momentum in the pharmaceutical industry, but consultant Pasi Kemppainen says he would be “cautious” to implement the technology across the entire digital supply chain.

Emergent initiates $50m expansion, expects to hire 60

07-Jun-2018 By Melissa Fassbender

Emergent BioSolutions has initiated a $50m multi-year expansion at the company’s Baltimore, MD-based fill/finish facility.

Six-month serialization countdown in US: Think strategy and lead times, says CPO

04-Jun-2018 By Flora Southey

Drugmakers should allow time to test packaging and implement changes if needed, before the November DSCSA deadline, says contract packaging organization.

Recalled oral contraceptive packaged at Sharp Packaging Solutions, says Allergan

29-May-2018 By Flora Southey

Placebo capsules packaged out of order in Allergan’s Taytulla oral contraceptive blister pack have prompted a voluntary recall in the US.

Avara to buy Novartis site, signs sterile injectables supply deal

29-May-2018 By Flora Southey

Avara Pharmaceutical Services has agreed to buy Novartis’ sterile manufacturing facility and development centre in Quebec, Canada.

Researchers target rapid changes to downstream continuous manufacturing

29-May-2018 By Nick Taylor

Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.

Q&A

Pharma needs to understand the ‘agile’ and ‘nimble’ start-up mindset, says editor

28-May-2018 By Flora Southey

Pharmaceutical companies could learn from the start-up methodology when adopting next-gen technologies, says founding editor-in-chief of WIRED Magazine UK.

INTERPHEX 2018

Continuous manufacturing: Lower API volumes reduce development costs, says exec

24-May-2018 By Flora Southey

Continuous manufacturing can help drugmakers save on development costs by reducing API waste, says Trek Therapeutics’ Kevin Bittorf.

NEWS IN BRIEF

Canadian CDMO adds spray drying to support ‘poorly soluble drugs’

22-May-2018 By Flora Southey

Genvion has invested approximately $1.5m in spray drying and coating technology for solid dosage forms at its manufacturing facility in Canada.

Experts warn: If Europe doesn’t innovate, it will lose manufacturing to pharmerging countries

16-May-2018 By Flora Southey

An Irish-led initiative will advocate for regulatory change to secure and sustain the pharmaceutical manufacturing sector in Europe.

US FDA warning: Contamination risk at CDMO in North Carolina

16-May-2018 By Flora Southey

The US FDA has issued a warning letter to CDMO Ei LLC stating that topical drugs and pesticides are being made in the same building and with shared equipment.

Ardena continues M&A strategy with CMO buy

14-May-2018 By Flora Southey

CDMO Ardena has added drug product capabilities with the purchase of active pharmaceutical ingredient and excipient-focused Syntagon.

NEWS IN BRIEF

Dutch CPO expansion to ‘futureproof’ blistering lines

14-May-2018 By Flora Southey

A predicted increase of complex molecule production and last-minute packaging requirements is behind Tjoapack’s latest investment in the Netherlands.

Codexis outfits CDMO with biocatalyst tech in new partnership model

03-May-2018 By Melissa Fassbender

Codexis is setting up Porton Pharma Solutions with its biocatalyst technology as part of a strategic collaboration aimed at liberating potential cost reductions of up to 20%, says CEO.

US FDA warns Mexican OTC maker: Misbranded drugs, lost data, unsuitable water

02-May-2018 By Flora Southey

The US FDA has issued a warning letter to Mexican drugmaker Degasa SA. de C.V for violating good manufacturing practice (GMP) regulations for finished pharmaceuticals.

Serialization for Small Pharma: TraceLink targets low volumes and simple supply chains

26-Apr-2018 By Flora Southey

TraceLink has launched a serialisation offering for companies with simple supply chains and limited target markets.

Mayne Pharma opens $80m facility, expands CDMO offering

19-Apr-2018 By Melissa Fassbender

Mayne Pharma has opened a new 126,000-square-foot oral solid-dose manufacturing facility to meet demand driven by new product launches – and new revenue stream from its CDMO business.

ADENTS SERIALIZATION SUMMIT

Industry 4.0 led by the EU, US, and China, says tech expert

19-Apr-2018 By Flora Southey

The fourth industrial revolution is here, and some countries are embracing digitisation and advanced manufacturing techniques faster than others, says Siemens exec.

Falsified Medicines Directive: Assess CMO relationships now or pay the price later

12-Apr-2018 By Dan Stanton

Pharma must brace itself for production scheduling clashes and cost challenges ahead of next year’s Falsified Medicines Directive (FMD) says PharmSource.

ADENTS SERIALIZATION SUMMIT

Selling serialization data could help recuperate costs, says Medicines for Europe exec

12-Apr-2018 By Flora Southey

Selling information from Europe’s national data repositories could help recover serialisation costs, says Medicines for Europe’s Johan Verhaeghe.

Making the switch: L.B. Bohle talks longterm benefits of continuous manufacturing

10-Apr-2018 By Flora Southey

Having the right company mindset is key when switching from batch manufacturing to the continuous method, says equipment vendor L.B. Bohle.

Freeze-dry inspection tech to lower process costs, says Antares Vision

10-Apr-2018 By Flora Southey

Antares Vision will launch its LYO-Check technology in North America, designed to inspect freeze-dried products for the pharmaceutical industry.

Novartis upping presence in gene therapies through $8.7bn AveXis buy

10-Apr-2018 By Staff Reporter

Novartis will add an AAV9 gene delivery platform and manufacturing facility through the $8.7bn (€7bn) acquisition of AveXis.

Talk and tech: CMOs taking a stand at Interphex

10-Apr-2018 By Staff Reporter

The contract manufacturing industry will be represented at this year’s Interphex through a dedicated pavilion sponsored by advocacy group PBOA.

Twist Bioscience secures $50m to advance DNA Synthesis Platform

03-Apr-2018 By Melissa Fassbender

The synthetic DNA provider Twist Bioscience Corporation has completed a private placement of $50m to advance its proprietary, silicon-based DNA Synthesis Platform.

Ongoing regulatory issues helps downgrade Wockhardt’s ratings

03-Apr-2018 By Dan Stanton

India Ratings has downgraded Wockhardt partly on the back of ongoing remediation at seven manufacturing facilities.

Hanmi invests in ‘smart plant’ to boost CDMO biz

29-Mar-2018 By Staff Reporter

South Korean firm Hanmi Pharmaceutical has invested 150bn won ($140.7m) in a manufacturing ‘smart plant’ to increase its contract services.

Consortium looks to make bacteria for anti-inflammatory drug delivery to the gut

29-Mar-2018 By Dan Stanton

Porton Biopharma will look to develop GMP manufacturing capabilities for Clostridia bacteria as part of a UK collaboration developing aimed at developing microbiome targeted therapeutics.