Fill-Finish & Packaging

Roche accused of charging too much for Herceptin in South Africa

13-Jun-2017 By Gareth Macdonald

Roche has been accused of charging too much for its breast cancer drug trastuzumab by South African competition authorities.

Update - BioMarin to hire 50 people at Shanbally

US FDA clears BioMarin to make $380,000-a year Vimizim in Ireland

12-Jun-2017 By Gareth Macdonald

The US FDA has cleared BioMarin Pharmaceutical Inc. to make the enzyme replacement drug Vimizim (elosulfase alfa) at its plant in Cork, Ireland.

Takeda breaks ground on $45m Ninlaro plant in Ireland

06-Jun-2017 By Staff Reporter

Takeda has begun construction of an Irish facility to support production of its orally delivered blood cancer peptide Ninlaro (ixazomib).

Merck & Co. €280m spend in latest commitment to Irish biomanufacturing

31-May-2017 By Dan Stanton

Global demand for its biologics and vaccines has driven expansion plans and 300 jobs across two Irish facilities says MSD.

Second time the charm for Pfizer’s Epogen biosimilar in US

30-May-2017 By Dan Stanton

An advisory committee has recommended approval of Retacrit in the US after Pfizer addressed manufacturing and clinical concerns from its first submission in 2015.

LSNE tapped for drug substance manufacturing, fill/finish services

25-May-2017 By Melissa Fassbender

LSNE Contract Manufacturing has signed a manufacturing supply agreement with Selecta Biosciences, Inc. through which the CDMO will advance Selecta’s lead candidate, SEL-212.

BPI Europe 2017

Cost-cutting oral vaccine tech will make Vaxart less reliant on CMO

04-May-2017 By Dan Stanton

Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.

Wearable drug delivery tech firm Unilife files for Chapter 11 bankruptcy

20-Apr-2017 By Gareth Macdonald

Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.

Cobra to boost gene therapy and CAR-T capacity through £15m investment

18-Apr-2017 By Gareth Macdonald

Cobra Biologics has said it will spend £15m ($19m) to increase gene therapy production capacity, citing customer demand and market opportunities.

GE aiming to be cell therapy production services one-stop-shop

12-Apr-2017 By Dan Stanton

GE Healthcare has acquired cryopreservation technology firm Asymptote and says more investments are likely as it builds an “end-to-end ecosystem” for cellular therapy production services.

Automation acquisitions 'capture the future of streamline production,' expert

12-Apr-2017 By Dan Stanton

There is a growing trend among vendors to integrate automation technologies into their offerings says a bioprocessing expert, as GE Healthcare invests in its partner Zenith.

Permira to buy Lyophilization Services of New England

28-Mar-2017 By Gareth Macdonald

Private equity fund Permira has announced its intention to buy freeze drying firm Lyophilization Services of New England Inc (LSNE) 

Lilly: Tax reforms would release $150m to further support US manufacturing

27-Mar-2017 By Dan Stanton

Eli Lilly will invest $850m in its US operations this year but warns the country’s antiquated tax system leaves the firm at a competitive disadvantage.

Patheon: Biologics seeds to bloom in 2018 as products shift to commercial

17-Mar-2017 By Dan Stanton

Patheon says it expects to see a surge in biologics revenue in 2018 as products shift from development stage to commercial.

Russia approves first ever biosimilar of Serono’s MS drug Rebif

03-Mar-2017 By Dani Bancroft

Russia’s Ministry of Health has awarded Biocad marketing authorisation for a biosimilar version of EMD Serono’s Multiple sclerosis drug Rebif (interferon beta-1a).

Ohr Pharmaceutical Inc. shuts sustained release tech lab

23-Feb-2017 By Gareth Macdonald

Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.

CellGenix GmbH starts work on cell therapy regent facility expansion

21-Feb-2017 By Gareth Macdonald

CellGenix GmbH has started expanding its cell and gene therapy reagents facility in Freiburg, Germany citing the progression of customer projects into clinical development and commercial launch.

Biocon's second fill/finish line at Bangalore site to come online later this year

Mylan and Biocon Neulasta biosimilar to go under US FDA scrutiny

17-Feb-2017 By Dan Stanton

Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.

Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia

10-Feb-2017 By Gareth Macdonald

Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.

Sanofi awaits FDA inspection of fill/finish plant before Q1 Kevzara resubmission

09-Feb-2017 By Dan Stanton

Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.

Roche: 'Largest biomanufacturing capacity across the industry' to get bigger

07-Feb-2017 By Dan Stanton

Roche says it will continue to expand its biologics manufacturing capacity while reducing its small molecule network.

Saudi CDMO’s fill/finish plant to offer Big Biopharma access to local benefits

01-Feb-2017 By Dan Stanton

Saudi Biotech Manufacturing has selected Swedish engineering firm KeyPlants to design and build a fill/finish plant for biological APIs.

Amatsigroup buys French Pyrofree manufacturing specialist Disposable-Lab

23-Jan-2017 By Dani Bancroft

Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.

Cell preservation prosperity: BioLife and Cryoport up on personalised meds

20-Jan-2017 By Dan Stanton

With increased interest in cell and gene therapies, BioLife Solutons has reported a 28% year-on-year growth in sales of biopreservation media, while Cryoport has struck another logistics deal.

Biopharma survey: Shortage of bioprocessing talent key threat to sector

20-Jan-2017 By Dan Stanton

Industry is struggling to find and develop skilled bioprocessing workers according to respondents to NIBRT’s biopharma trends survey.

Amgen teams with Immatics on cancer immunotherapies

11-Jan-2017 By Gareth Macdonald

Amgen will manufacture, trial and sell cancer immunotherapies developed in collaboration with Immatics Biotechnologies GmbH under an agreement announced this week.

OTCQB: PMCB

Cell-in-a-Box: PharmaCyte seeks FDA advice for inoperable cancer trial

06-Jan-2017 By Dani Bancroft

PharmaCyte has announced a pre-application meeting with the US FDA, to advise on their investigational new drug (IND) filing for a clinical trial its live cell encapsulation therapy.

COLD CHAIN

Cryoport to deliver Gradalis autologus immuno-oncology therapies across US

05-Jan-2017 By Dani Bancroft

Cryoport’s network of cold chain logistics will support the delivery of Gradalis Inc’s autologous cell therapy to various cancer trial sites across the US.

US FDA delays Ocrevus decision date asking Roche for more manufacturing data

23-Dec-2016 By Gareth Macdonald

The US FDA has pushed back the review date Roche’s Ocrevus (ocrelizumab) after asking for more data on processes used to manufacture the candidate MS treatment.

Cook and Asymptote to launch water-free automated cell thawing tech

30-Nov-2016 By Dan Stanton

An automated system co-developed with Cook Regenetec offers a more controlled and repeatable method of thawing cell and gene therapies than traditional techniques, says Asymptote.

Kymab secures $100m and two new Chinese backers

25-Nov-2016 By Gareth Macdonald

Antibody developer Kymab has secured $100m from existing backers and new China-based investors Hepalink and ORI Healthcare Fund.

Cold chain challenges evolving with industry, Cryoport

23-Nov-2016 By Melissa Fassbender

While the temperature is dropping outside, keeping clinical trial therapeutics and biospecimens at the right temperature during transportation is a challenge year-round.

Lyophilised biologic reconstitution IP up for grabs after XstalBio folds

22-Nov-2016 By Staff Reporter

A technology developed to reduce time and increase safety when reconstituting lyophilised biologics has been put for up for sale after XstalBio's insolvency.

One down, five to go: Autolus takes space at UK cell & gene therapy centre

22-Nov-2016 By Dan Stanton

T-cell immunotherapy firm Autolus has become the first tenant at the Cell and Gene Therapy (CGT) Catapult manufacturing facility in the UK.

Novasep eyes Japan's bioprocessing market with chromatography BD contract

18-Nov-2016 By Dan Stanton

Novasep has expanded a partnership with AR Brown to supply its chromatography equipment to Japanese biomanufacturers.

Pfenex: consistently high manufacturing quality key for biosimilar success

15-Nov-2016 By Dan Stanton

Manufacturing quality is key for biosimilar success says Pfenex, as the US FDA continues to increase its regulatory oversight.

Unilife confirms focus on wearables delivery tech for biologics

03-Nov-2016 By Gareth Macdonald

Unilife has confirmed its intention to wind down its prefilled syringe business and focus on wearable technologies used to deliver biopharmaceuticals.

Sanofi and Regeneron mull FDA CRL after fill/finish plant hit with 483

31-Oct-2016 By Dan Stanton

The US FDA has issued a complete response letter for Sanofi and Regeneron’s rheumatoid arthritis candidate sarilumab due to manufacturing deficiencies at a fill/finish plant in France.

Bespak welcomes availability of Cimzia autoinjector on the UK NHS

28-Oct-2016 By Gareth Macdonald

Bespak says the availability of the autoinjector version of UCB’s Cimzia on the UK National Health Service (NHS) is a validation of its delivery technology.

Nordic Nanovector ASA signs second ADC deal in a month

28-Oct-2016 By Gareth Macdonald

Nordic Nanovector ASA and Heidelberg Pharma GmbH will develop antibody drug conjugate (ADC) treatments for leukaemias under a deal agreed this week.

Unilife in talks with customers about planned wind-down of syringe business

27-Oct-2016 By Gareth Macdonald

Unilfe has started discussing the wind-down of its prefilled syringe business with customers after deciding to focus on wearable drug delivery technologies.

China's Tot Biopharm starts work on second plant with eye on ADC market

19-Oct-2016 By Gareth Macdonald

Tot Biopharm has started work on a second monoclonal antibody (mAb) drug production plant at China’s Suzhou Industrial Park.

Samsung Bioepis contracts Catalent to help commercialize Benepali

19-Oct-2016 By Gareth Macdonald

Samsung Bioepis has contracted Catalent to provide fill finish services for its Enbrel (etanercept) biosimilar, Benepali.

FDA approves Protein Sciences quadrivalent flu vaccine

14-Oct-2016 By Dan Stanton

The US FDA has approved a quadrivalent formulation of Protein Sciences’ vaccine, Flublok, produced without eggs or the influenza virus.

AstraZeneca snaps up second Amgen biologics plant in Colorado

11-Oct-2016 By Dan Stanton

AstraZeneca says it will use the acquired plant as a warehouse to support biomanufacturing operations at a nearby facility, previously purchased from Amgen.

Advocacy group criticises EC's plan for stand-alone cell & gene therapy GMP doc

30-Sep-2016 By Dan Stanton

European stand-alone guidelines for the manufacture of Advanced Therapy Medicine Product (ATMP) could lead to disparities in GMP standards, says the Alliance for Regenerative Medicine.

Allergan bolts on optogenetics platform with RetroSense buy

07-Sep-2016 By Phil Taylor

Allergan has added to its fast-growing eye health portfolio by buying gene therapy firm RetroSense Therapeutics for $60m (€53m) upfront.

INFOGRAPHIC

The future of the biopharma industry: emerging markets and biosimilars

07-Sep-2016 By Dan Stanton

China and India are the most important growth markets for biopharmaceutical manufacturers, according to our state of the industry survey.

Vibalogics expands German fill/finish site on back of clinical demand

02-Sep-2016 By Dan Stanton

German CDMO Vibalogics has upped its capabilities 300% citing a lack of worldwide capacity for biologics fill and finish.

Dispatches from Korea

Inside Celltrion: a biosimilar success story built on landfill

30-Aug-2016 By Dan Stanton

Ambition, hard work and a focus on quality has made Celltrion the ‘pioneers of the mAb biosimilar industry,’ the firm told Biopharma-Reporter during a tour of its biomanufacturing site in Songdo, Korea.