Fill-Finish & Packaging

update

The age of phage? World first cGMP certification for phage therapy plant

03-Jun-2015 By Gareth Macdonald

AmpliPhi Biosciences’ phage-based antibacterial therapies plant in Ljubljana has been deemed to meet manufacturing standards by Slovenian regulators.

Novartis to assess biologics with micro-sugar-needle delivery tech

27-May-2015 By Dan Stanton

Novartis has partnered with Google-backed Rani Therapeutics to assess an oral platform which delivers biologics through the intestinal wall using needles made of sugar.

AstraZeneca eyes up flexible single-use tech at $285m Swedish biologics plant

19-May-2015 By Dan Stanton

Single-use technologies will ensure flexibility at a $285m (€255m) biologics plant being constructed in Sweden, says AstraZeneca.

Alexion growing biologics network through €450m Irish plant

13-May-2015 By Dan Stanton

Alexion will expand its manufacturing network with a €450m ($507m) biologics facility in Ireland, a week after entering an $8.4bn agreement to acquire Synageva.

Lilly builds drug delivery and device R&D site

12-May-2015 By Fiona BARRY

Eli Lilly is building a drug delivery and device innovation centre in Cambridge, Massachusetts.

Celgene in $450m deal to commercialise MedImmune's anti-PD-L1 candidate

28-Apr-2015 By Dan Stanton

AstraZeneca has inked a development and commercialisation deal with Celgene for its haematology programmed cell death ligand 1 (PD-L1) candidate, MEDI4736.

Sigma-Aldrich opens doors to latest Singapore biopharma investment

22-Apr-2015 By Dan Stanton

Sigma-Aldrich has opened a cell culture Technical Center in Singapore and plans to expand further in the city-state with a cGMP distribution site.

CMOs earn €8.4m in EU grants to help scale-up manufacturing of thermo-stable vaccines

20-Apr-2015 By Zachary Brennan

A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.

Dispatches from BPI 2015

Sartorius' new cell harvesting tech uses brewing sector filtration knowhow

15-Apr-2015 By Dan Stanton

Sartorius has launched a cell harvesting technology, the first to incorporate diatomaceous earth filtration more commonly associated with the brewing industry.

EMA: TTIP and inspection databases a way of improving global manufacturing standards

31-Mar-2015 By Gareth Macdonald

Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.

US FDA rejects Amgen bid to force biosims firms to share info before review

27-Mar-2015 By Gareth Macdonald

Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.

Genentech plans $125m expansion of Oregon manufacturing facility

27-Mar-2015 By Zachary Brennan

Genentech will invest more than $125m to expand its fill/finish facility in Hillsboro, Oregon. 

Orgenesis buys cell therapy CMO to cut manufacturing costs and diversify revenue stream

11-Mar-2015 By Gareth Macdonald

Orgenesis has bought Masthercell SA to take control of production of its Type 1 diabetes cell therapy candidate ahead of clinical trials.

Anthrax vaccine stability data delivers contract extension for Glide Technologies

09-Mar-2015 By Gareth Macdonald

US desire for an alternative to the current multi-shot anthrax vaccine is a boon for delivery systems firm Glide Technologies, which had its contract extended by Pfenex this week.

Production of wart drug with anti Ebola potential set to restart in New Jersey

05-Mar-2015 By Gareth Macdonald

Hemispherx will make a candidate Ebola treatment being trialled by the US military at its revamped plant in New Jersey.

Celltrion explains two-brand Remicade biosimilar strategy

24-Feb-2015 By Gareth Macdonald

Celltrion says the two-brand strategy for its Remicade biosimilar will help it cater for local needs and cultural differences.

Repligen finishes plant expansion and forecasts higher tech revenues in 2015

13-Feb-2015 By Gareth Macdonald

Repligen has finished an expansion at its US filtration system facility eight months after bolstering its offering in this area by buying a platform from Refine Technology.

Long manufacturing timeline hampers annual flu vaccine strain selection, experts say

04-Feb-2015 By Zachary Brennan

US government scientists told a House subcommittee on oversight and investigations on Tuesday that the six months production time necessary for flu vaccine manufacturers can create difficulties for health experts selecting the appropriate virus strains...

CMO free? Novo Nordisk investing $760m in homegrown network

03-Feb-2015 By Dan Stanton

Novo Nordisk will invest up to $760m in its manufacturing network in the coming year to support the growth of its insulin portfolio.

US dollar prompts ThermoFisher to predict flat revs in 2015 and move reagents to Lithuania

30-Jan-2015 By Gareth Macdonald

ThermoFisher has forecast flat sales and earnings in 2015, warning that weaker currencies in key markets will offset higher biopharma spending.

Tech that can untangle hard boiled eggs could save biopharma time and money, say researchers

28-Jan-2015 By Gareth Macdonald

Researchers have used shear stress to repair misfolded proteins in an approach that could help biopharmaceutical firms bypass expensive refolding techniques and time-consuming cell line optimization.

Novozymes predicts half-life boost for pharma business, but lets long term rev forecast slide on oil prices

20-Jan-2015 By Gareth Macdonald

Novozymes finished 2014 with higher pharma revenues thanks in part to GSK's adoption of its albumin half-life extension technology, Veltis.

Agilent: Biologics growth presents biggest consumables opportunity

21-Nov-2014 By Dan Stanton

The growth in biologics has given Agilent Technologies a “huge opportunity for services and consumables,” according to the firm’s CEO-Elect.

GE sets up in Istanbul in bid to capture a share of Turkish tech market

14-Nov-2014 By Gareth Macdonald

Turkey’s efforts to increase local biopharmaceutical production have prompted GE Healthcare Life Sciences to set up a biopharmaceutical technology training centre in Istanbul.

Amgen files FDA petition, lawsuit seeking info on Sandoz biosimilar manufacturing

07-Nov-2014 By Zachary Brennan

The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.

Dispatches from AAPS 2014

GSK ‘moves best people’ to keep Ebola vaccine manufacture in-house

07-Nov-2014 By Fiona Barry

GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.

SAFC, Baxter partner to offer ADC contract manufacturing

26-Sep-2014 By Zachary Brennan

SAFC and Baxter’s BioPharma unit are working together to contract manufacture ADCs (antibody drug conjugates) for biopharma companies.

Emergent scales up manufacturing of anthrax vaccine

24-Sep-2014 By Zachary Brennan

Emergent BioSolutions has initiated a non-clinical study to demonstrate it can scale-up production of its anthrax vaccine, BioThrax, without making it less effective.

Ampio shares tumble as albumin-derived trial drug suffers case of the chills

22-Aug-2014 By Dan Stanton

Ampio Biopharmaceuticals will delay the release of Ampion trial data after discovering the drug was damaged by temperature fluctuations during shipment.

BioLife: Freeze media sales to grow as more biologics enter market

08-Aug-2014 By Dan Stanton

Second quarter sales of cryopreservation media grew 14% but BioLife Solutions says it expects revenues to skyrocket as clients’ biologics move out of the clinical stage..

Arecor and CPI team on biologics stability research project

17-Jun-2014 By Gareth Macdonald

Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.

Merck to invest $68m in Italian biopharma production site

23-May-2014 By Zachary Brennan

As part of an effort to meet a rising demand for biopharmaceuticals, Germany-based Merck has agreed to invest about $68m (€50m) in its Italian production site in Bari. 

Survey finds solid base for early phase cell therapy manufacturing in UK

20-May-2014 By Zachary Brennan

The UK manufacturing sector covers all of its bases in terms of the current cell therapy manufacturing requirements and includes “a strong manufacturing base” to bring early phase academic research into the clinic, according to a survey conducted by Cell...

Cytovance to scale up mAb for Selexys’s Phase I trial

16-May-2014 By Fiona BARRY

Cytovance will use both single-use and stainless steel in its monoclonal antibody (mAb) manufacturing deal with Selexys Pharmaceuticals.

Biopharma turns to outsourcing for more common, simple tasks, survey finds

29-Apr-2014 By Zachary Brennan

Biopharma is ramping up the outsourcing of some of the easier tests while tasks such as downstream process development and QbD services are being outsourced less, according to a new survey.

Thermo Fisher: new pumps compatible with all bioprocessing techs

16-Apr-2014 By Gareth MACDONALD

Thermo Fisher has launched a pump technology designed for applications across the bioprocessing production line and usable with "all" bioprocessing tech.

Adaptimmune selects Biolife's freeze media for T-Cell therapy trials

04-Apr-2014 By Dan Stanton

Adaptimmune has selected Biolife’s cryopreservation media for its genetically modified T-cell receptor (TCR) product citing its ability to retain viability and potency.

Janssen and Novozymes: toxic drugs could change from daily to monthly

21-Mar-2014 By Fiona BARRY

Janssen has asked Novozymes Biopharma to help it reduce drug dosage “from daily to every two weeks or monthly” using its half-life extension technology.

DISPATCHES FROM INTERPHEX

To QbD or not to QbD? For biologics it's a must says Cook Pharmica expert

19-Mar-2014 By Dan Stanton

The thorny issue of applying QbD to biopharmaceutical manufacture is a topic of hot debate at Interphex 2014 according to CMO Cook Pharmica.

Start spreading the news, Interphex opens today

18-Mar-2014

When Frank Sinatra sang "If you can make it there, you can make it anywhere" in New York, New York he probably wasn't talking about biopharmaceutical production.

US FDA defers to USP standards in draft guidance on injectable volume excess

18-Mar-2014 By Zachary Brennan

The US FDA says that it “becomes concerned” when excess volume in an injectable vial is greater or less than what the US Pharmacopeia (USP) recommends without proper justification, according to new draft guidance.

Patheon and DSM fully complementary for biologics post-merger, says DPx Exec

14-Mar-2014 By Dan Stanton

Patheon brings fill/finish capabilities to DSM’s biomanufacturing services, President of Biopharma at the recently merged company DPx told Biopharma-Reporter.com in an exclusive interview.

Bayer invests $700m in recombinant Factor VIII manufacturing

12-Mar-2014 By Dan Stanton

Bayer is investing over €500m ($700m) in manufacturing recombinant factor VIII (rFVIII) products citing growing demand for long-term prophylactic treatment rather than ‘on-demand’ haemophilia drugs.

No plans for second Irish plant, says Regeneron

05-Mar-2014 By Dan Stanton

Regeneron has denied it has plans for a fill/finish facility to complement its new $300m (€219m) biomanufacturing plant in Limerick, Ireland.

Demand for plasmid production growing says Cobra Biologics

04-Mar-2014 By Dan Stanton

Cobra Biologics is looking for more scientists with plasmid production skills after BioCancell became the fifth firm in a year to ask the CMO to manufacture a DNA-based gene therapy candidate.

US FDA offers guidance on analytical procedures and methods validation for biologics

21-Feb-2014 By Zachary Brennan

The US FDA has issued draft guidance to help the biopharmaceutical industry assemble information and present data to support its analytical methodologies. 

Fight for Life: new Thermo Fisher acquisition loses out in India

18-Feb-2014 By Gareth Macdonald

Life Technologies has had its efforts to stop an Indian namesake using certain trademarks and web domains thrown out by the Delhi High Court.

Amgen plant hit with US FDA Warning over Enbrel combination product

12-Feb-2014 By Dan Stanton

The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.

GSK: Halt in chicken pox vaccine manufacture to continue into Q2

31-Jan-2014 By Dan Stanton

Shipments of chicken pox vaccines from a troubled Belgian facility should recommence in early Q2 2014, says GSK, though the root cause of the manufacturing issues are still unknown.

Double biologics expansion for CMOs Gallus and Cytovance

31-Jan-2014 By Fiona Barry

Contract manufacturers Cytovance and Gallus have both invested millions of dollars in expanding their biologics-manufacturing facilities.