Processing equipment

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.

Site closure, staff cuts: Arbutus reshuffles in Vancouver

13-Feb-2018 By Flora Southey

Arbutus Biopharma Corporation is cutting operations but says it remains committed to developing its messenger RNA drug delivery technology.

Novo Nordisk: Demand drives another equipment boost in Clayton, US

07-Feb-2018 By Flora Southey

Novo Nordisk is planning a $65m (€53m) production capacity expansion at its finished product site in North Carolina, to meet demand for diabetes and obesity medicines.

Nordic project takes ‘manufacturing-on-demand’ approach to future drugs

07-Feb-2018 By Dan Stanton

Nordic Universities will investigate 3D printing, electrospraying, and microfluidics in an industry supported collaboration aimed at revolutionising production in an age of personalised medicine.

AstraZeneca aims for ZS Pharma kidney drug approvals in H1 2018

06-Feb-2018 By Dan Stanton

AstraZeneca says its hyperkalaemia candidate ZS-9 is back on track for approval after manufacturing issues at its Texas facility resulted in regulatory delays.

IDA Ireland says Alkermes job cuts ‘regrettable but understandable’

06-Feb-2018 By Flora Southey

A portfolio shake-up will result in staff lay-offs at Alkermes’ manufacturing facility in Ireland, says the firm.

Celltrion slammed with US FDA warning at biosimilar site

02-Feb-2018 By Dan Stanton

Celltrion says supply of Pfizer’s Inflectra is secure, despite receiving a US FDA warning letter at its biosimilar production plant in Korea.

Marchesini Group invests in serialisation software and 3D printing

01-Feb-2018 By Dan Stanton

Pharma packaging firm Marchesini Group has acquired 48% of its serialisation software partner SEA Vision and forged a long-term agreement worth €125m.

FDA upgrades Kansas plant but Hospira’s legacy continues to haunt Pfizer

31-Jan-2018 By Dan Stanton

The US FDA has upgraded the status of Pfizer’s McPherson manufacturing, hit with a warning letter last year.

Intas puts the fizz back into ex-Sanofi plant with generic effervescents

31-Jan-2018 By Flora Southey

Intas Pharmaceuticals says it ‘worked hard’ over two years to bring an ex-Sanofi manufacturing facility back into production in Newcastle, UK.

Hovione adds inhalation product development tech at former Generis site

30-Jan-2018 By Staff Reporter

Hovione has bolstered its encapsulation for inhaled products technology capabilities at its site in Portugal.

Amneal expands NY site ahead of Impax merger

30-Jan-2018 By Flora Southey

Amneal Pharmaceuticals expects to bring production of some Impax Laboratories’ drugs in-house through a 100,000 sq. ft. expansion at its site in New York state.

Meissner expands aseptic fill/finish range through PDC acquisition

18-Jan-2018 By Staff Reporter

Meissner Filtration Products has bolstered its automated filling offerings through the acquisition of PDC Aseptic Filling Systems.

Telix sets up subsidiary to make and trial radio-labelled meds in Japan

17-Jan-2018 By Gareth Macdonald

Radiopharmaceuticals firm Telix Pharmaceuticals Limited has established a subsidiary in Japan to support clinical development and manufacturing activities.

Eisai ups capacity for Alzheimer’s disease pills and PPIs in China

11-Jan-2018 By Gareth Macdonald

Eisai Co Ltd has completed construction of an oral solid dose form manufacturing facility in Suzhou, China.

Aslan to make Array's small molecule cancer drug varlitinib under new licensing deal

08-Jan-2018 By Gareth Macdonald

Aslan Pharmaceuticals Pte Ltd has licensed manufacturing and sales rights to Array BioPharma’s candidate small molecule pan-HER inhibitor varlitinib.

MilliporeSigma and bluebird bio ink multi-year viral vector deal

03-Jan-2018 By Flora Southey

Bluebird Bio has hired MilliporeSigma to supply lentiviral vectors for the development of gene therapies.

Recipharm to pay INR2.8bn for remaining stake in injectables firm Nitin Lifesciences

02-Jan-2018 By Gareth Macdonald

Recipham has agreed to pay the founders of Nitin Lifescience Limited INR2.8bn ($44m) for the remaining 26% stake they own in the India-based drug manufacturer.

News in brief

Colorcon and Applied DNA Sciences sign tech MOU

20-Dec-2017 By Staff reporter

Colorcon Inc. and Applied DNA Sciences Inc. have teamed up to commercialize an on-dose traceability platform they say will help combat counterfeits.

TxCell set to transfer production process for candidate organ rejection cell therapy to CMO

19-Dec-2017 By Gareth Macdonald

TxCell SA has developed the production process for it range of CAR-Treg based therapies and is preparing to transfer it to its CMO ahead of first-in-human trials.

3D-printing on trend: Aprecia and Cycle sign orphan drug deal

14-Dec-2017 By Flora Southey

Three-dimensional printing technology is attracting increased attention from the US FDA say Aprecia and Cycle, which have announced a partnership to develop 3D-printed orphan drugs.

US FDA looks to answer industry's 3D printed drug concerns

12-Dec-2017 By Dan Stanton

3D printing offers “a tantalizing step toward changing the manufacturing processes” for personalised medicines says a US FDA scientist.

Tjoapack ups bottling capacity to feed pharma's packaging needs

05-Dec-2017 By Dan Stanton

Tjoapack has tripled its bottle packing capacity as increased legislative complexity, ageing populations and pricing pressures drive demand for outsourced packaging solutions.

News in Brief

US FDA inspection lands Glenmark with 483 with seven observations

28-Nov-2017 By Dan Stanton

Glenmark has received a US FDA Form 483 with seven observations at its Baddi finished formulations facility in Baddi, India.

Serial pursuit: Second phase of US track and trace rules begins today

27-Nov-2017 By Dan Stanton

Recipharm says three more of its facilities are equipped and ready for US Drug Supply Chain Security Act (DSCSA) serialisation demands, the deadline for which passes today.

Chinese API plant slammed by US FDA and placed on import alert

27-Nov-2017 By Dan Stanton

The US FDA has issued API manufacturer Hubei Danjiangkou Danao Pharmaceutical a warning citing failures in its quality control unit.

Fresenius Kabi investing $100m and adding 445 jobs in North Carolina

22-Nov-2017 By Dan Stanton

Encouraged by a North Carolina state grant, Fresenius Kabi will expand its prefilled syringes business acquired from Becton, Dickinson and Company in 2016.

Oregon drugmaker feels heat as FDA says to get out the kitchen

21-Nov-2017 By Dan Stanton

The US FDA has slammed Ridge Properties for making drug products using “kitchen utensils and cookware” in a warning letter sent last month.

AbbVie claims strike did not stop operations at Irish plant

15-Nov-2017 By Dan Stanton

Trade union members picketed AbbVie’s bulk tablet facility in Cork yesterday but the firm says operations and supply have not been disrupted.

Recipharm cutting Swedish manufacturing but ‘unlikely’ to sell facilities

13-Nov-2017 By Flora Southey

Recipharm says it will cease manufacturing at sites in Stockholm and Höganäs, citing ‘underperforming operations’ at its package filling and manufacturing-focused sites.

Codexis expects ‘significant revenue’ from Nestlé collaboration

13-Nov-2017 By Dan Stanton

The recently inked development partnership with Nestlé Health Science could net Codexis upwards of $350m.

UPDATE

IMA Life inks Atonarp’s freeze-drying tech

09-Nov-2017 By Flora Southey

IMA Life is boosting its freeze-drying (lyophilisation) and aseptic processing services with Atonarp’s miniaturised mass spectrometry technology.

Lupin receives US FDA warnings at two Indian manufacturing plants

08-Nov-2017 By Dan Stanton

Indian drugmaker Lupin says product supply will not be disrupted at plants in Goa and Indore hit with a combined US FDA warning letter.

Mutual recognition: US to accept GMP inspections from eight EU regulators

02-Nov-2017 By Dan Stanton

The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.

Shire to sell Milford facility

Shire expects to be making some Cinryze in-house early next year

31-Oct-2017 By Gareth Macdonald

Shire has said it is on track to start making some Cinryze in-house next year to address supply problems at Dutch contractor Sanquin.

Lonza maintains 2017 target and says US plant and Capsugel integration on track

26-Oct-2017 By Gareth Macdonald

Lonza has reaffirmed its full-year sales and earnings forecast and updated about its US operations and the integration of Capsugel.

update

US FDA rejects Translarna and says additional trial and CMC data is needed

26-Oct-2017 By Gareth Macdonald

The US FDA has rejected the muscular dystrophy candidate Translarna (ataluren), telling PTC Therapeutics more trial data is needed to prove the drug works and asking for additional information about how it is made.

Sartorius Stedim Biotech cuts guidance citing hurricane, destocking and supply problems

25-Oct-2017 By Gareth Macdonald

Sartorius Stedim Biotech (SSB) has cut its full year guidance, citing the negative impact of hurricane Maria, customer destocking and ongoing issues with a cell culture media supplier.

Correction

US FDA issues Akorn with Form 483 for Decatur plant

25-Oct-2017 By Gareth Macdonald

US FDA inspectors have raised concerns about Akorn Inc’s manufacturing facility on Grand Avenue in Decatur, Illinois in a Form 483 made public this month.

Recipharm kits out Lisbon plant in latest stage of serilization tech roll out

23-Oct-2017 By Gareth Macdonald

Recipharm has installed serialization technology at its contract production facility in Lisbon, Portugal citing impending US and EU rules as a driver for the investment.

Rutgers and NJII to set up continuous manufacturing institute

19-Oct-2017 By Gareth Macdonald

The New Jersey Innovation Institute and Rutgers University have teamed up to establish an institute to promote the development of continuous manufacturing technologies for drug production.

Little impact on pharma biz, says hurricane hit J&J

18-Oct-2017 By Dan Stanton

Back-up generators and secondary manufacturing sites limited the supply and financial impact of Hurricane Maria across J&J’s Puerto Rican pharma facilities, the firm says.

Ex-Hurricane Ophelia & Ireland-based manufacturing: Pfizer, Roche & Takeda update

18-Oct-2017 By Flora Southey

Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.

CordenPharma ups Swiss API development services

16-Oct-2017 By Staff Reporter

CordenPharma has invested in its Swiss API development services a week after buying a manufacturing plant from Pfizer.

Nestle licenses Codexis' enzyme platform and protein drugs for $14m

12-Oct-2017 By Gareth Macdonald

Nestle Health Science has licensed a protein engineering platform from Codexis in a $14m deal that includes an option to co-develop a phenylketonuria drug candidate called CDX-6114.

Depomed warns of Nucynta ER delays citing damage to Puerto Rico CMO

11-Oct-2017 By Gareth Macdonald

Depomed Inc. says supplies of the extended release version of Nucynta will be delayed as a result of damage to a Puerto Rico manufacturing plant caused by hurricane Maria.

Avara buys French site: AZ talks what, why and where to next

10-Oct-2017 By Flora Southey

Following the announced sale of AstraZeneca’s solid dose facility to Avara, the former outlines the Reims, France-based sites capabilities, and tells us why it is letting it go.

Biotech Week Boston

Beyond SOPs: Janssen talks tech transfer complexities

09-Oct-2017 By Dan Stanton

Successfully transferring manufacturing tech to a second facility or CMO relies on site readiness and sponsor oversight, says Janssen.

Gilead hands rights to make HIV drug candidate to firms in developing countries

05-Oct-2017 By Gareth Macdonald

Gilead Sciences Inc. has licensed production rights to its candidate HIV drug bictegravir to the Medicines Patent Pool (MPP).

Merck KGaA to spend €35m to replace filling line at Bari facility

04-Oct-2017 By Gareth Macdonald

Merck KGaA will install a new aseptic filling line at its facility in Bari, Italy for multiple sclerosis drugs, fertility treatments and growth hormones.