Competitivity of K-Pharma-Bio manufacturing facilities rises

ST Pharm’s oligonucleotide manufacturing plant becomes the first plant in Asia to pass U.S. FDA inspection

Inist ST becomes first to register anticancer drug API manufacturing facility in Korea

Samsung Biologics succeeds in trial manufacture of mRNA drug substance following CMO of finished mRNA product

The competitiveness of K-Pharma/Biomanufacturing facilities are rising.

 

With more and more companies passing inspections by the US FDA (Food and Drug Administration), the institution considered to have the highest standards, the companies that have passed inspections plan to advance into the global market in earnest.

 

Recieves first cGMP certification in Asia for its oligonucleotide manufacturing plant

ST Pharm recently became the first in Asia to receive the US FDA’s Good Manufacturing Practice (cGMP) certification for its oligonucleotide plant.

 

The company received an inspection classification of NAI (No Action Indicated) from FDA’s PAI (pre-approval inspection) of its oligonucleotide factory in Banwol Campus, demonstrating the R&D capability of its facility.

 

With the approval, the company’s oligonucleotide orders are expected to increase.

 

Although ST Pharm had only been exporting drug substances for oligonucleotide treatment used in clinical trials to the US market, the recent FDA cGMP approval will now enable the company to make large-scale exports for commercial use.

 

An ST Pharm official said, “We have 4 more FDA PAIs planned by the first half of next year.

 

This means that FDA approvals of new drugs that ST Pharm supplies drug substances for is imminent.

 

The FDA cGMP approval the company received this time is expected to positively impact the future on-site inspections in plan.” Registered as the first anticancer drug API manufacturing facility in Korea

Inist ST’s Osong plant has also recently been registered as a cGMP anticancer drug API manufacturing facility by the FDA.

 

With the registration, the Osong plant became the first cGMP-certified anticancer API manufacturing facility registered as a highly active noncytotoxic anticancer API specialized manufacturing facility A company official said, “With the news spreading, we are receiving a series of love calls from existing and new customers that aim to advance into the US and other advanced pharmaceutical markets.

 

The FDA certification has reaffirmed our global-level API manufacturing facility and quality control capabilities.” By passing FDA inspections, the pre-investment that had been made by Inist ST is also gaining momentum.

 

In October last year, the company started the construction of a 40 billion won 'Global API synthesis cGMP plant' on the site of the Osong plant site to expand its CMO business.

 

The facility is expected to be completed in October.

 

Succeeds in manufacturing COVID-19 mRNA drug substance in addition to finished product

Samsung Biologics succeeded in trial manufacture of the mRNA drug substance.

 

With the company's success in establishing the mRNA drug substance facility following the successful CMO of Moderna’s finished mRNA product in the 2nd half of last year, the company has now established a one-stop end-to-end mRNA production system.

 

The company signed aCMO partnership with the US company GreenLight Biosciences for the drug substance of GreenLight’s COVID-19 vaccine candidate at the end of last year.

 

For 7 months since then, the company completed technology transfer, scale-up and established its RNA drug substance manufacturing facility in May this year.

 

Samsung Biologics recently succeeded in the first trial manufacture and has finished preparations for the large-scale commercial manufacturing of the mRNA vaccine drug substance.

 

Trial production is a process verification stage that is carried out before full-scale commercial production.

 

The success of the pilot manufacturing is considered as having full capacity at the cGMP level.

 

The second trial production is expected to take place within this month.

 

A market official said, “An increasing number of pharmaceutical and biopharmaceutical companies have passed FDA’s inspections with their differentiated manufacturing facilities.

 

Such facility R&D is now treated as competitive as the company's material R&D.”