Tag Archives: Novartis

CDMO Celonic for cell strengthening and gene therapy is working in the growing hub of Novartis | Instant News


Like many CDMOs of late, Celonic from Switzerland aims to make major breakthroughs in cell and gene therapy – and is taking space in Novartis’ burgeoning life science center to take that work to the next level.

Celonic sews a long-term lease for production and office space in the WST-222 building from a prospective Novartis hub in Stein, Switzerland, dubbed Life Science Park Rheintal. The company will use the 91,500 square feet site prepare production capacity for cell and gene therapy, next-generation vaccines, and “innovative biopharmaceuticals”.

Celonic adds up to 20 clean room suites, plus offices and laboratories for process development, method development and quality control for clients from early stage work to market. It will also sign around 250 new employees to staff the sites, which will be ready for production in the second quarter of 2022.

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RELATED: Cognate beefs up cell, gene therapy manufacturer with a new factory in US, EU

The company hopes to offer large-scale manufacturing of so-called advanced therapies – drugs derived from genes, tissues or cells – as early as next year, said CEO Konstantin Matentzoglu in a release.

Outside of Stein, Celonic too build manufacturing facilities for gene vectors and cell therapy at its location in Basel, Switzerland, according to the company’s website. The plant will eventually be equipped to handle process development and optimization through to initial commercialization, as well as clinical production.

Celonic joins the Novartis site with 2,000 staff from three pharmaceutical and biotech companies working in research, development and production.

Novartis in February revealed his plans change its Stein production site is a garden of life sciences, with an emphasis on the production of cell and gene therapy. Between 2020 and 2021, the company has invested more than 200 million Swiss francs ($ 218 million) into its locations in Stein and Schweizerhalle.

RELATED: Fujifilm is continuing its CMDO expansion with $ 76 million in funding for the new Boston site

Drugmakers and CDMOs alike have turned to expanding cell and gene therapy production in recent months. Just this week, China-based Pharmaron agreed to pay AbbVie $ 118.7 million for the Allergan Biologics production plant in Liverpool, UK – driving the cell and gene therapy ambitions that began with the purchase of Absorption Systems in November.

Catalent in February said it would pick up Plasmid DNA specialist Delphi Genetics, accelerated plasmid production at the company’s Rockville, Maryland site. Meanwhile, Bristol Myers Squibb, which has just secured its Breyanzi approval, is building a 244,000-square-foot cell therapy site on an 89-acre campus in Devens, Massachusetts – and those are just a few of the most recent examples.

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Novartis will help manufacture Pfizer’s COVID-19 vaccine | Instant News


Novartis has agreed to help manufacture a COVID-19 vaccine jointly developed by Pfizer and BioNTech to support the vaccine supply chain, the Swiss drugmaker. announced January 29th.

Using its manufacturing facility in Stein, Switzerland, Novartis will fill the vial with bulk messenger RNA (the active ingredient of the vaccine) and ship it to BioNTech. The amount has not been disclosed, as the deal reached a final agreement.

Novartis plans to start production in the second quarter of 2021, with initial deliveries slated for the third quarter.

Steffen Lang, Novartis’ head of technical operations, said in a news release that the drugmaker is committed to using its manufacturing capabilities to help end the pandemic and expects this agreement “to be the first of a number of such agreements.”

The announcement comes two days after French pharmaceutical giant Sanofi announced his plans to produce more than 125 million doses of the vaccine developed by Pfizer and BioNTech.

More articles on pharmacy:
Executives from the Cleveland Clinic, Baystate Health share the challenges facing their vaccine program
Antibody drug Eli Lilly COVID-19 reduces hospitalization, risk of death, trials
J&J says its COVID-19 vaccine is 66% effective

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Swiss giant Novartis will assist in the Pfizer / BioNTech vaccine | Instant News


GENEVA

Pharmaceutical giant Novartis said on Friday that it had signed a preliminary agreement to help produce a Pfizer / BioNTech vaccine against COVID-19 in Switzerland as drugmakers struggle to keep up with demand for injections.

“Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredients from BioNTech and fill them into bottles. [….] for shipping back to BioNTech for distribution to healthcare system customers worldwide, “the company said in a statement.

The agreement involves a rare collaboration among pharmaceutical competitors to create the first two-dose vaccine recognized for emergency use by the World Health Organization (WHO).

The developments come as the big pharmaceuticals have come under fire for not meeting some expectations about a vaccine in the fight against a pandemic that has created tensions involving communities, drug companies and governments.

Under the final agreement, Novartis plans to start production in the second quarter of this year at its aseptic plant in Stein, Switzerland.

The first deliveries of the finished vaccine are expected to be made in the third quarter of this year.

“Novartis has mobilized in various fields to support the global pandemic response,” said Steffen Lang, head of Novartis Technical Operations.

“We are committed to enhancing our manufacturing capabilities to help support the worldwide supply of COVID-19 vaccines and therapies. We hope this will be the first of a number of such agreements.”

On Thursday, Hans Kluge, WHO’s regional director for Europe, said rising expectations for science and vaccine development are causing tension in the community as cases and deaths swell.

“The rising expectations of science and vaccine development, production and fair distribution cannot be met as quickly as we would like,” said Kluge, saying the public felt the end of the pandemic was in sight with vaccines.

At the same time, he said, a population “called upon to abide by restrictive measures in the face of new threats is causing tension, anxiety, exhaustion and confusion.”

Novartis said around 50 state health watchdogs had approved the Pfizer / BioNTech COVID-19 vaccine.

These include Switzerland and EU member states, while the vaccine has received authorization for emergency use in the UK, US, Canada and Hong Kong.


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Brazil approves Sinovac for immediate launch | Instant News


Brazil recently approved the CoronaVac vaccine produced by Beijing-based pharmaceutical company Sinovac, allowing the largest country in Latin America to start its immunization program.

In a recently concluded clinical trial involving 12,476 healthcare workers in Brazil, CoronaVac demonstrated 100% protection against severe COVID-19 and hospitalization. This trial is currently the only publicly available Phase 3 clinical trial involving the COVID-19 vaccine. The participants are all medical staff deployed in the hospital. Therefore, it provides a practical indication of the ability of this vaccine to protect key medical personnel. Chile has also approved CoronaVac’s emergency use approval. Sinovac has signed agreements with at least eight countries (including Turkey, Singapore, Indonesia, Thailand, Philippines, Malaysia, Chile and Brazil). In the Philippines, CoronaVac recently received approval from a single joint research ethics committee of the Philippine Food and Drug Administration and the Ministry of Health to conduct clinical trials. The study, sponsored and funded by IP Biotech, Inc., will be a randomized, double-blind, placebo-controlled clinical trial for volunteers aged 60 to 80.

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