Florida Biologix wins ASC-101 contract

By Gareth Macdonald

- Last updated on GMT

Related tags Pharmaceutical industry Pharmacology

US CMO Florida Biologix (FB) says its new contract with America Stem Cell (ASC) shows that demand for trial-phase biologics manufacturing is starting to recover.

Under the deal FB will undertake process and assay development, as well as manufacture of ACS’ candidate engrafment enhancer ASC-101 at its good manufacturing practices (GMP) accredited facility in Alachua, Florida.

FB spokesperson Chris Aytug told Outsourcing-Pharma that: “This work involves production of [the] enzyme in a serum-free suspension CHO culture. The development involves scale-up and improving feeding strategies for batch culture as well as developing downstream processes and release assays.”

She explained that ASC has asked for “gram quantities​” of the drug for upcoming Phase I clinical trials, adding that: “This is well within our capacity, which tops out at 400L in a disposable stirred-tank bioreactor.”

Demand picking up

Aytug went on to say that demand for this type of manufacturing is increasing after the initial shock of the global economic downturn and its impact on pharmaceutical industry spending.

Things were slow but are picking up now. We see an increasing demand for reasonably priced Phase I/II development and manufacturing, which has supported our decision to increase our cell culture capacity.”

The Floridian firm, which was set up in 2006 as an operating unit of the Center of Excellence for Regenerative Health Biotechnology (CERHB), recently expanded production capacity at its 23,000 sq ft facility.

Pharma funding drives biologics growth

Aytug also predicted that drug industry demand for contract biologics work will benefit those contract manufacturing organisations (CMO) that are flexible enough to help clients develop and execute the best process for their stage of development.

We believe that the increase in development of biologic therapeutics, both gene/cell and protein based, will continue.

The most significant factors driving this demand are the positive results and favorable safety profiles associated with many protein therapeutics currently under development and the increasing numbers of large pharmaceutical companies helping to fund these programs​.”

Related news

Related products

show more

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Related suppliers

Follow us


View more