Experic: Ser­vice for clin­ical studies

Since the begin­ning of 2019, the newly founded US com­pany Experic has been offering con­tract ser­vices for the man­u­fac­turing, pack­aging, labeling and global logis­tics of clin­ical trial mate­rials and spe­cialty com­mer­cial sup­plies. Experic is focused on the small, mid­size, and spe­cialty phar­ma­ceu­tical cus­tomer looking for an expe­ri­enced partner and a high level of per­son­al­ized service.

The pro­duc­tion of clin­ical trial mate­rials can present a real chal­lenge, espe­cially for small phar­ma­ceu­tical com­pa­nies, niche providers and start-ups: Small batch sizes must be pro­duced under strict GMP guide­lines (depending on the trial phase, between 10 and 10,000+ patients par­tic­i­pate in the studies).

Having the right equip­ment tech­nology is another key com­po­nent when it comes to suc­cess­fully pro­ducing clin­ical trial sup­plies. How­ever, invest­ment in the appro­priate equip­ment at the clin­ical trial phase can be cost pro­hib­i­tive for many small phar­ma­ceu­tical com­pa­nies. A poten­tial solu­tion is to find a con­tract ser­vice provider who can offer the right equip­ment tech­nology, under­stands the impor­tance of a scal­able process, and can cater to the needs of small and spe­cialty phar­ma­ceu­tical clients.

“The Harro Höfliger prin­ciple is based on com­pre­hen­sive man­u­fac­turing processes from the lab­o­ra­tory to pro­duc­tion scale.“ Dr. Justin Lacombe, Director Phar­ma­ceu­tical Devel­op­ment at Experic

Unfor­tu­nately, given the number of mergers and acqui­si­tions in this field over the past few years there are fewer alter­na­tives to choose from and it has become more chal­lenging for this seg­ment of phar­ma­ceu­tical com­pa­nies to find the right partner.Experic, a US based com­pany started to address this problem in early 2019. As a partner for smaller com­pa­nies, ­Experic man­u­fac­tures and pack­ages clin­ical trial mate­rials and spe­cialty com­mer­cial sup­plies on the customer’s behalf. Equipped with state-of-the-art dosing machines from Harro Höfliger and a blister machine from Uhlmann, Experic covers the entire spec­trum of cap­sule and blister filling.

“The Harro Höfliger prin­ciple is based on com­pre­hen­sive man­u­fac­turing processes from the lab­o­ra­tory to pro­duc­tion scale,” explains Dr. Justin Lacombe, Director Phar­ma­ceu­tical Devel­op­ment at Experic. “Fol­lowing pos­i­tive clin­ical results using drug prod­ucts made on pilot-scale equip­ment, product and man­u­fac­turing process know-how can be seam­lessly trans­ferred to Harro Höfliger pro­duc­tion sys­tems with the same under­lying tech­nolo­gies. The com­bi­na­tion of a con­sis­tent single source and crit­ical tech­nology reduces the risk of having to modify the process at a later stage, saving time and, of course, money.”

The clin­ical trial phases

Plans for the for­ma­tion of Experic date back to 2015. During this early phase, Harro Höfliger was already involved in the project and later became an investor. “With Experic, we see a huge poten­tial for our US cus­tomers,” says Peter Brun, Team Leader Pharma Ser­vices at Harro Höfliger. “The facility closes an impor­tant gap in the pro­duc­tion and the pri­mary and sec­ondary pack­aging of small series of phar­ma­ceu­ti­cals in the US. More­over, it serves as a high-tech show­room where cus­tomers can expe­ri­ence our tech­nology live.”

The com­pre­hen­sive ser­vice offering not only includes pro­duc­tion, but also a GMP ware­house, DEA vault and world­wide dis­tri­b­u­tion of clin­ical trial mate­rials. “With Experic, start-ups and smaller phar­ma­ceu­tical enter­prises gain an expe­rienced partner who can guide them with pro­fes­sional exper­tise during clin­ical studies all the way to product approval,“ explains Thomas Weller, CEO at Harro Höfliger.

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Photo: Experic