Breaking News on Biopharmaceutical Development & Manufacturing


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Gone to the dogs? Shire sells vaccine plant to Merck Animal Health

23-Aug-2017 - Shire has sold the former Baxalta vaccine facility in Austria to Merck Animal Health for an undisclosed fee.

Gilead ups capacity with Cali manufacturing facility

18-Aug-2017 - Biopharmaceutical firm Gilead Sciences has opened a facility in La Verne, California, US, which it says will boost manufacturing volumes.

Bioproduction bottlenecks increasing due to staff shortages, says report

16-Aug-2017 - A shortage in expertise is causing bottlenecks in the biomanufacturing space with around half of drugmakers struggling to fill processing positions, an industry report finds.

Reprocell grows cell and tissue-based services in Scotland

11-Aug-2017 - Human tissue-focused products and services firm Reprocell Europe has opened headquarters in Glasgow, Scotland, which it says will boost business and create jobs.

Avara agrees to buy ex-Hospira plant in Italy from Pfizer

10-Aug-2017 - Avara Pharmaceutical Services has agreed to buy Pfizer Inc. sterile drug manufacturing facility in Liscate, Italy.


Pfizer chooses Sanford, North Carolina site for $100m gene therapy plant

09-Aug-2017 - Pfizer has chosen a site in Sanford, North Carolina for a gene therapy production plant, just 40 miles from its recent acquisition Bamboo Therapeutics Inc.

US FDA clarifies what constitutes 'minor' change to biologic production process

09-Aug-2017 - The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week.


Hep B vaccine supply issues at Merck & Co and GSK prompt UK to prioritize access

08-Aug-2017 - Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK.

US FDA finds faults at Biocon plant slammed by French regulators in July

07-Aug-2017 - The US FDA has issued Biocon with a Form 483 detailing problems inspectors identified at a plant in Bangalore, India.

Kite assesses EU manufacturing options as it submits CAR-T therapy for review

04-Aug-2017 - Kite Pharma has submitted the first CAR-T candidate axicabtagene ciloleucel to the EMA for review and says it is evaluating manufacturing options in Europe.

Celltrion Healthcare $890m IPO to up biosimilar inventory and broaden portfolio

04-Aug-2017 - Celltrion Healthcare will purchase more biosimilars from biomanufacturing partner Celltrion Inc. and expand its distribution network after raising one trillion Won ($888m) in an IPO.


Modular single-use facilities rebalance Biopharma’s capacity scales

02-Aug-2017 - Modular facilities and single-use systems are fast becoming a standard part of the bioproduction infrastructure as industry looks to mitigate future capacity constraints.

Seattle Genetics gains first production site through $43m BMS plant buy

02-Aug-2017 - Seattle Genetics paid Bristol-Myers Squibb $17.8m for the biomanufacturing site and says it will spend a further $25.5m on equipment and improvements to support antibody production.

Biotest relocates Florida plasma center, ups workforce

01-Aug-2017 - Biotest Pharmaceuticals Corporation has relocated its Plasma Center in Pembroke Pines, Florida, US.

Lonza envisions five new plants at Visp for modular manufacturing biz

28-Jul-2017 - Lonza has started work on a facility to house its new modular tech-based biomanufacturing service at its site in Visp, Switzerland.

Novartis preps production platform for alternative to Lucentis

26-Jul-2017 - Novartis has scaled up manufacturing of wet age-related macular degeneration (AMD) monoclonal antibody RTH258 ahead of a potential regulatory submission next year.

Sartorius takes €10m hit on media sales due to Lonza's regulatory woes

26-Jul-2017 - Supply chain issues stemming from an FDA warning letter at a facility run by its partner Lonza have dampened Sartorius Stedim Biotech’s first half 2017 results.

Lonza sets CHF7.5bn 2022 sales target citing pharma drivers

26-Jul-2017 - Lonza Group AG has predicted it will generate annual revenue of CHF7.5bn ($7.9bn) by 2022, citing recent acquisition Capsugel and its new Visp-based Ibex manufacturing service as drivers.

Exclusive interview with CEO TH Kim

Samsung Biologics: Reducing COGS could double mammalian CMO use to 50%

25-Jul-2017 - Samsung Biologics wants Big Pharma to up biomanufacturing outsourcing and says lessons learned from the semiconductor industry will give it the advantage in the CMO space.

Boehringer Ingelheim expands in California, adds 300 jobs

25-Jul-2017 - Boehringer Ingelheim has announced a $217m (€186m) expansion and upgrade to its manufacturing facility in Fremont, California, US.

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