Processing equipment

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.

Eisai enters strategic API supply deal with Nich-Iko

29-Mar-2018 By Dan Stanton

The active ingredient for Nichi-Iko’s diabetic neuropathy drug will be the first of a number of APIs to be supplied from Eisai’s facility in Vizag, India.

Romaco launches wax and fat coating hot melt machine

27-Mar-2018 By Staff Reporter

Romaco Group has launched a machine for coating pharmaceutical products with hot fats and wax it says can reduce hot melt processing times by 85%.

Blockchain for pharma: DHL, Imperial and Authentag embrace ledger tech

22-Mar-2018 By Flora Southey

Three contract services firms have launched separate Blockchain-based initiatives, in a bid to increase pharmaceutical supply chain security.

Contamination risk from vermin lands Indian API firm with US warning

21-Mar-2018 By Dan Stanton

Inspectors observed birds and insects inside an API facility run by Malladi Drugs & Pharmaceuticals, according to a US FDA warning letter.

Sterling taps Nanologica tech for peptide purification

20-Mar-2018 By Flora Southey

Sterling Pharma Solutions says it will boost its chromatography services with Nanologica’s silica particles production technology.

Thermo Fisher plans operations reshuffle and 170 job cuts in UK

20-Mar-2018 By Flora Southey

Thermo Fisher Scientific says its proposal to move manufacturing and R&D operations from Ashford, Kent to existing sites in Mexico, China and Denmark was a “very difficult decision.”

Dr Reddy's receives FDA 483 at Indian API plant

19-Mar-2018 By Dan Stanton

The US FDA has issued a Form 483 with four observations to an API facility in Hyderabad, India run by Dr Reddy’s Laboratories.

Recipharm boosts sterile injectables capabilities in France

19-Mar-2018 By Flora Southey

CDMO Recipharm has added an eighth Blow-Fill-Seal filling and packaging line to its Kayserberg, France facility, to increase sterile liquid services.

Dutch API maker bought by CDMO to boost development offering

15-Mar-2018 By Flora Southey

CDMO Ardena has purchased active pharmaceutical ingredient and nanomedicine maker ChemConnection, as part of an acquisition strategy focused on development services.

Upperton upping spray-dry production in $2m relocation

15-Mar-2018 By Staff Reporter

Spray-drying service provider Upperton Pharma Solutions has expaned to offer GMP manufacturing for early-stage clinical trials.

What to expect at DCAT Week 2018

13-Mar-2018 By Melissa Fassbender

This year’s DCAT Week will focus on innovation in the pharmaceutical industry, with two new Executive Insights programs.

Update

PE-backed CMO expands syringe filling capabilities

06-Mar-2018 By Melissa Fassbender

Grand River Aseptic Manufacturing (GRAM) has purchased a new syringe filler to help meet "the rising demand" for parenteral development and manufacturing services.

Latest GMP crackdown leaving ‘naive’ cosmetic firms with FDA warnings

06-Mar-2018 By Dan Stanton

Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.

Aurobindo injectables plant receives Form 483 with nine observations

05-Mar-2018 By Dan Stanton

The US FDA has issued a Form 483 to a manufacturing plant in Hyderabad, India but Aurobindo says none of the observations relate to data integrity.

The Beast from the East takes on Ireland: Takeda and Jazz temporarily shut sites

01-Mar-2018 By Flora Southey

A clash between Storm Emma and Arctic temperatures over Ireland has forced the closure of two Takeda sites in Dublin, and Jazz Pharmaceuticals’ Athlone facility.

WuXi STA to make oligonucleotides for Regulus

01-Mar-2018 By Staff Reporter

Regulus Therapeutics has entered into an oligonucleotide synthesis collaboration with STA Pharmaceuticals for research and mid-scale non-GMP/cGMP manufacturing.

AkzoNobel targets peptide makers with expanded Kromasil offering

28-Feb-2018 By Flora Southey

AkzoNobel Specialty Chemicals has boosted its Kromasil capacity, used to facilitate the separation of compounds in drug development.

AMRI expanding testing services in EU as European client base grows

28-Feb-2018 By Melissa Fassbender

AMRI is expanding its container closure integrity testing (CCIT) services in the European Union (EU), with further services to be added later in 2018.

Fujifilm building $37m facility to support liposome drugs

27-Feb-2018 By Dan Stanton

Toyama Chemical’s facility will support trials of lipsome drugs produced using technologies cultured through Fujifilm’s photographic film business.

Pfizer’s McPherson site: Recalls and repeat observations

26-Feb-2018 By Flora Southey & Dan Stanton

The detection of cracks of the surface of glass vials has prompted a voluntary recall of Labetalol Hydrochloride Injection made at Pfizer’s troubled McPherson, Kansas facility.

Lonza ups HPAPI encapsulation capacity in Florida

22-Feb-2018 By Staff Reporter

Lonza has increased its encapsulation capacity and invested in highly potent active pharmaceutical ingredient (HPAPI) services at a facility in Tampa, Florida.

West Pharma to merge manufacturing and exit sites in network shake-up

21-Feb-2018 By Flora Southey

A network reshuffle will see West Pharma consolidate manufacturing and close some facilities to “streamline” its plant network.

Biocon says FDA 483 at Malaysian plant not due to non-compliance

21-Feb-2018 By Dan Stanton

A US FDA pre-approval inspection of Biocon’s insulin manufacturing facility in Malaysia has resulted in a Form 483 with six observations.

USV receives FDA close-out at Indian plant

20-Feb-2018 By Staff Reporter

The US FDA has lifted a warning at an Indian oral solid dose manufacturing facility run by USV Private Limited.

ImmunoGen closing MA plant: 20 jobs to go, $20m in savings

15-Feb-2018 By Staff Reporter

ImmunoGen says it is shifting drug conjugate manufacturing and quality testing to an outsourcing model and will close its Norwood facility.

Generics, mergers and Teva’s woes: Agilent talks pharma opportunities

15-Feb-2018 By Dan Stanton

Agilent Technologies says changes in the industry this year will present opportunities for continued growth in its pharma processing equipment and consumables business.

Remediation and modernisation plans: Bayer responds to FDA warning

14-Feb-2018 By Dan Stanton

Bayer expects some temporary supply limitations affecting its mature product portfolio as it addresses GMP issues raised in a US FDA warning.

MSD repurposing dormant Irish site and hiring 350 to support Keytruda

14-Feb-2018 By Dan Stanton

Merck Sharp & Dohme (MSD) plans to build a biologics facility at a former small molecule manufacturing site in Swords, Ireland, which it closed last year.

US FDA slams Bayer for ‘inadequate cleaning' and 'discarded records’

13-Feb-2018 By Dan Stanton

Bayer has received a US FDA warning letter at its finished pharmaceutical facility in Leverkusen, Germany.