This week,
SpeakPharma interviews Jackie Labbe, Vice-President,
Sales & Marketing, Phyton Biotech, a global supplier of high-quality active
pharmaceutical ingredients (APIs) made through plant cell fermentation (PCF).
Paclitaxel and docetaxel are both taxanes. The two APIs have historically been derived from Pacific yew trees, and are used in the treatment of cancer. In the interview, Labbe talks about Phyton’s PCF technology, and how its scalability makes it a cost-competitive and sustainable alternative to traditional extraction manufacturing processes.
— What is plant cell fermentation technology? How do you use it to make biotech APIs? And how is this technology cost-competitive?
Plant cell fermentation (PCF) technology is the ability to use
plant cells to make active chemical compounds that are typically extracted from
plant biomass. Phyton uses this technology to produce various active pharmaceutical ingredients (APIs), while assuring a sustainable supply chain that does not depend on variations in climatic conditions, and also doesn’t lead to an exploitation of precious natural resources. The technology is scalable, while also being cost-competitive.
Using our PCF
technology, we produce various cancer-fighting molecules like paclitaxel and docetaxel. Recently, we also entered into
partnerships to develop various other compounds to ensure a sustainable supply
of many new chemical entities.
Since PCF technology is scalable, Phyton is able to
expand production as and when required. This way, it is able to take advantage
of economies of scale when our demand increases.
The scalability of
the PCF technology, along with its lack of dependence on the natural plant raw
materials, makes it a cost-competitive alternative to traditional extraction
manufacturing processes.
— How has PCF helped overcome the supply chain challenges of taxanes and other natural products?
Over the years, the
growing demand for taxane APIs created significant pressure on the yew trees
from which a key building block of these APIs had historically been
derived. The over-exploitation of
natural resources got to a point where trade of the Himalayan yew species was
severely restricted.
Phyton Biotech developed and applies sustainable and “green” chemistry manufacturing solutions for phytochemicals using PCF, which now serve the pharmaceutical as well as the traditional Chinese medicine (TCM), cosmetic, agricultural and food ingredient industries.
By utilizing our revolutionary PCF platform,
we are able to offer a time, risk, and cost-balanced path to commercially
viable production processes.
With certified GMP
facilities in Germany and Canada, Phyton combines highly developed technology
and quality that meets the needs of its global customers.
We have a successful
track record of developing and implementing innovative contract development
solutions for clients around the world.
Since Phyton has a
yew tree cell bank, the company has complete control over the key starting
ingredient. This allows Phyton to function independent of cost
fluctuations that may be attributed to starting ingredients used in traditional
paclitaxel manufacturing process. The same principle applies to other natural
products developed via PCF.
— Tell us a little about the history of taxanes.
The history of
taxanes dates back to 1962, when a bark from the Pacific yew tree (Taxus
brevifolia), was collected as part of the US National Cancer Institute (NCI)
natural products screening program.
Samples derived from
this bark showed cytotoxic effects and it was not until 1977, when the NCI was
able to confirm anti-tumor activity in mouse models. The active molecule was
paclitaxel. It later became available under the brand name Taxol.
Subsequent research
has shown that taxanes worked in a completely different way from other
cytotoxic drugs.
Paclitaxel is now included on the World Health Organization’s Model List of Essential Medicines.
While initial commercial production of paclitaxel was achieved through direct extraction from the Pacific Yew, over time it became possible to manufacture the API using a precursor of paclitaxel, 10-deacetyl baccatin III, which was more widely available. In December 1992, the FDA approved Taxol for the treatment of ovarian cancer.
— What are some of the regulatory challenges you face? And how are you able to comply with the regulatory standards and GMPs?
Our paclitaxel is
produced according to good manufacturing practices (GMPs) from the moment we remove a vial
containing plant cells from the cryobank for production.
GMP is continued all
the way through the fermentation and purification process, and until it is
shipped to our customers as a finished API. Both our paclitaxel and
docetaxel are produced according to the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP)
and our manufacturing facilities have been inspected and approved by all the
leading global health authorities.
Our APIs are also
supported with Drug Master Files and Certificates of Suitability and we have
successfully demonstrated to regulators the consistently high quality of our
products.
— What are your future plans? How do you plan to take the PCF technology forward?
Our aim is to expand
the number of products produced by applying our plant cell fermentation to
products in niche markets across pharmaceutical, traditional herbal medicines, food
and nutrition and cosmetics.
— In a world where sustainable supply of drugs is a big challenge, how can PCF help?
Excellent question.
As you are aware, we are the global leaders in
specialty fermentation, with the knowhow, expertise, and infrastructure to
develop, scale up, and commercially manufacture phytochemicals and recombinant
proteins via plant cell fermentation.
PCF is definitely
one of the ways to produce some drugs sustainably because the source of the
active ingredient is produced independent of plant biomass.
As I mentioned before, PCF is scalable, so our entire production can be scaled up or down as needed with very minimal effort. This characteristic of our PCF technology makes us have a minimal environmental footprint while ensuring a sustainable supply of drugs that are cost-competitive.
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