Cevec: Single cell line tech to move protein expression rapidly to market
Rainer Lichtenberger is touching down in Barcelona for BIO-Europe Spring after a year spent circling the globe meeting potential partners and closing agreements for Cevec Pharmaceuticals. And he is looking for more business.
Rainer Lichtenberger, Cevec Pharmaceuticals
“Time to market means everything for pharma companies, so when we said we could reduce the process by six months, that got a lot of attention,” said Dr Lichtenberger, the CEO at Cevec.
So far the company has announced two agreements and, according to world traveler Lichtenberger, “there are many, many licensing discussions going on at this moment, which we can not speak about for publication, of course.”
Eliminating the need to switch cell lines between drug discovery and drug production also promises to save millions of dollars in development costs, but this has proven less compelling for customers than increasing the speed-to-market, he said in an interview with partneringNEWS.
This time last year Cevec released CAP-T, a transient human cell line for rapid protein expression in drug discovery and development, as a complement to the existing Cevec amniocyte production (CAP) technology, which is a high yield process for permanent human protein expression used for biopharmaceutical production.
In other words, both researchers and drug developers working on the same program now can use the same cell line technology from the original research all the way to market-scale production.
“Until Cevec introduced this unique single cell line capability, companies needed to switch cell lines after research to move to a technology capable of meeting the higher volume requirements of production,” explained Lichtenberger.
“They might start producing a few milligrams for clinical testing using hamster cells, for example, and then move to human cell line production for later stage investigations,” he explained. “This switching requires a lot of laborious and lengthy work to rebuild analytical tools and testing methods, to document all of the changes, to repeat tests and validate results. It becomes expensive as well.”
There was an immediate interest by US-based pharma and biotechs, as well as some Asian contract manufacturing groups, he said.
“In the USA we are certainly excited about the rapid acceptance, and are well ahead of our ambitions,” reported Lichtenberger. “In Europe we are pleased with our progress, though it is a little below where we hoped to be at this time.”
“And in Asia, where we expected a slow uptake, I would say we are surprised by the successes and we are ahead of our targets,” he claimed. “In Asia there is a broad range of cultures, traditions and attitudes that can be quite conservative in some nations while in others, such as Singapore, Taiwan or Malaysia where we already have clients, we have found them open and accepting of this novel technology.”
European companies tend to be more conservative when it comes to new biological techniques, he added “which is quite a paradox considering the respective regulatory authorities have the opposite positions.”
“Yet Europe is decidedly our home turf, and our participation at BIO-Europe Spring is an important part of our efforts this year to move forward,” he said.
“We are targeting early stage development and later stage drug discovery among three types of potential partners,” he said.
“For biotech companies developing or discovering new molecular targets we have a the CAP-T technology that is an essential tool to express the proteins they are investigating. For larger pharmaceuticals, we have the CAP platform capable of high volume cell line production. And, finally, there is a strong interest among CMOs seeking versatile and effective cell line production for their client’s proteins,” he commented.
Lichtenberger said he is not seeking meetings with investors, having closed a financing round in October 2009 for EUR 4.5 million.
“For our core business we do not need additional financing, we need sales,” he confirmed.
“The most interesting projects for us at this moment are those that will lead to late stage production licenses because we helped a company to develop a successful product using Cevec cell lines,” he said.
The only challenge for Cevec is arriving later to the market with its original CAP technology than hoped, due to a four-year dispute with Crucell NV surrounding that company’s PER.C6 cell line used as a human expression system.
“We are now totally free of any claims on our intellectual property,” said Lichtenberger.
“Up until the last lawsuit was decided in mid-2008, it was extremely difficult to sign a contract with anyone because there was a cloud over our heads and a customer could not be 100 percent confident about our offer,” he said.
“Today we enjoy amicable relations with Crucell,” he added. “We are certainly competitive in the market, but we speak regularly, and there is no longer any issue about the IP.”
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