Novasep signs €4.7m biomanufacturing deal with biotech

By Zachary Brennan

- Last updated on GMT

Here's a look at one of Novasep's fermentors.
Here's a look at one of Novasep's fermentors.

Related tags Gene therapy Virus Biotechnology

Novasep has signed a €4.7m ($5.4m) agreement with Celladon, a clinical-stage biotechnology company, to prepare to supply the drug substance for the heart failure treatment Mydicar.

The deal covers scale-up and pre-validation studies and also includes the facility enhancement engineering Novasep will make at its Seneffe, Belgium, bioproduction plant to enable it to bring Mydicar into commercial production.

Mydicar is currently undergoing several clinical phases, including a phase IIb study in the US.

With this agreement, Novasep will support Celladon’s plans to produce Mydicar on accelerated timelines​,” said Alain Lamproye, president of Novasep Biopharma. “We are leveraging over ten years’ experience in developing and manufacturing viruses and viral vector products to enable Celladon to meet its goal of bringing MYDICAR to the market as soon as possible. We consider this contract a reward for our strategy of developing custom manufacturing capabilities for novel virus and viral vector based therapies​.”
In addition, Novasep and Celladon have agreed to negotiate further terms for a commercial supply agreement until December 31, 2018. This is subject to the early termination of certain specified Mydicar regulatory and development outcomes, with extension options until 2020.
Mydicar is a genetically-targeted enzyme replacement therapy for advanced heart failure based on AAV/SERCA2a, an Adeno-Associated Virus (AAV).

The deal to manufacture Mydicar follows the company’s decision to invest in ADC manufacturing​ at a French plant, as well as to reach double-digit growth​ last year.

Related news

Show more

Related products

show more

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Addressing Challenges with Clinical In-Use Testing

Addressing Challenges with Clinical In-Use Testing

Content provided by Lonza | 12-Oct-2023 | White Paper

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

Related suppliers

Follow us


View more