Part­ner with the right bio­an­a­lyt­ics firm at start-up to de-risk drug de­vel­op­ment

One of the most im­por­tant drug de­vel­op­ment start-up de­ci­sions is find­ing a cen­tral­ly lo­cat­ed bio­an­a­lyt­i­cal lab­o­ra­to­ry that can sup­port clin­i­cal re­search across all the study lo­ca­tions, and through pre-clin­i­cal then po­ten­tial­ly for all Phas­es.

Qual­i­ty con­trol and con­sis­ten­cy of sam­ple man­age­ment and analy­sis from ear­ly Phase on­wards can make a re­al dif­fer­ence to qual­i­ty of da­ta and fi­nal out­comes.

Se­lect­ing a lab that can work across time zones and col­lab­o­rate close­ly with the CRO and spon­sor with reg­u­lar re­port­ing and 24×7 avail­abil­i­ty can save valu­able time and en­sure full com­pli­ance with sites across Asia, Aus­tralia, USA, EU and East­ern Eu­rope.

Hav­ing the right bio­an­a­lyt­ics part­ner that can de­liv­er con­sis­ten­cy is a key to suc­cess­ful clin­i­cal re­search, even if the CRO and site lo­ca­tions change through­out the clin­i­cal phas­es.

The on­ly FDA In­spect­ed Lab

Aus­tralia-based Ag­ilex Bi­o­labs, the on­ly FDA-in­spect­ed lab in the Asia re­gion, is a glob­al­ly fo­cussed fa­cil­i­ty that spe­cialis­es in ear­ly Phase stud­ies and sup­ports spon­sors through the full drug de­vel­op­ment process.

Ag­ilex Bi­o­labs has seen rapid growth of more than 40% over the past 2 years as spon­sors and CROs recog­nise the cal­i­bre of Aus­tralian sci­en­tists, and Ag­ilex Bi­o­labs’ track-record of 300 ear­ly phase clin­i­cal tri­als.

Ag­ilex Bi­o­labs has just cel­e­brat­ed its first year as a sep­a­rate com­pa­ny, hav­ing evolved from par­ent com­pa­ny CPR Phar­ma Ser­vices.

Ja­son Valen­tine, CEO, Ag­ilex Bi­o­labs

CEO Ja­son Valen­tine said in our 20 years of per­form­ing reg­u­lat­ed bio­analy­sis of small and large mol­e­cules, we have ac­cel­er­at­ed hun­dreds of pre­clin­i­cal and clin­i­cal tri­als around the world.

The com­pa­ny, po­si­tioned in the same time-zone as most of Asia and work­ing overnight while the USA sleeps, is able to de­liv­er re­al ad­van­tages in speed and sup­port.

More than 60 per­cent of the Ag­ilex Bi­o­labs client base is from the U.S, while 30% is from the Asia re­gion.

Valen­tine said many clients come to Aus­tralia for their ear­ly phase tri­als be­cause of the qual­i­ty of re­search and the Gov­ern­ment R&D re­bate of up to 43.5%.

“With over ten years of ex­pe­ri­ence, our sci­en­tists are ca­pa­ble of de­vel­op­ing and val­i­dat­ing the most com­plex as­says for pre­clin­i­cal and clin­i­cal pro­grams.”

“Then clients stay with us through the lat­er clin­i­cal Phas­es be­cause we can sup­port their stud­ies glob­al­ly.”

Ju­lia Jones, VP Busi­ness De­vel­op­ment

“Ag­ilex Bi­o­labs is the lead­ing bio­an­a­lyt­ics lab in the re­gion so we are a nat­ur­al choice.”

“Our 65 per­son ex­pe­ri­enced sci­en­tif­ic team is rapid­ly scaled for speed across mul­ti­ple time-zones.”

Im­munol­o­gy ex­pan­sion at Ag­ilex Bi­o­labs

Im­munol­o­gy is a broad area of sci­ence that in­ter­sects mul­ti­ple ther­a­peu­tic ar­eas of emerg­ing im­por­tance in Asia. Build­ing on its strong im­munoas­say team, Ag­ilex is ex­pand­ing its suite of ser­vices to in­clude im­muno­log­i­cal as­sess­ments to in­ves­ti­gate the po­ten­tial im­pact of the drug on the im­mune sys­tem. Ser­vices will in­clude im­munophe­no­typ­ing and re­cep­tor oc­cu­pan­cy as­says by flow cy­tom­e­try, bio­mark­er as­sess­ments with Lu­minex and Mesoscale and cell-based as­says for mode of ac­tion, im­muno­genic­i­ty and cy­tokine re­lease, to as­sist clients bet­ter un­der­stand the mech­a­nisms be­hind their drugs and ful­ly eval­u­ate the ef­fects of test com­pounds.

Sci­en­tif­ic lead­ers

Ag­ilex Bi­o­labs taps the best of Aus­tralia and around the world hav­ing re­cent­ly pro­gressed visa ap­provals for an­a­lysts and spe­cial­ists from as far as the UK.

The Ag­ilex Bi­o­labs In­tern­ship en­cour­ages PhD stu­dents to learn about the com­pa­ny and share the lat­est knowl­edge – which al­so means the com­pa­ny is first in line to re­cruit the best once they grad­u­ate.

The Tech­nol­o­gy

The com­pa­ny’s boasts the lat­est tech­nol­o­gy in­clud­ing the Sci­ex 4000 LC-MS/MS, Sci­ex QTRAP 5500 LC-MS/MS, Spec­tra­Max Plate Read­er, Mesoscale Dis­cov­ery Sys­tem (MSD) and Gy­ro­lab xPlore that de­liv­er the most ac­cu­rate da­ta for clin­i­cal tri­als.

Plat­forms – LC-MS/MS Bio­analy­sis

Ag­ilex Bi­o­labs con­ducts high per­for­mance, reg­u­lat­ed bio­analy­sis by liq­uid chro­matog­ra­phy tan­dem mass spec­trom­e­try (LC-MS/MS) analy­sis of small mol­e­cules, pep­tides and pro­teins.

Our ded­i­cat­ed LC-MS/MS team of ex­perts av­er­ages over 15 years of ex­pe­ri­ence each. Our ar­eas of ex­per­tise in­clude: new chem­i­cal en­ti­ties (NCEs), sug­ars, nu­cleotides, enan­tiomers, steroids, pro­drugs, pep­tides, im­muno­sup­pres­sants, nanopar­ti­cles, neu­ro­trans­mit­ters, oligonu­cleotides and poly­mer­ic mix­tures. Learn more.

Im­munoas­say bio­analy­sis

Ag­ilex Bi­o­labs are recog­nised in­dus­try lead­ers in high per­for­mance, reg­u­lat­ed im­munoas­say bio­analy­sis of large mol­e­cules. Our sci­en­tists have over 10 years ex­pe­ri­ence in de­vel­op­ing and val­i­dat­ing ro­bust com­pli­ant PK, PD and Im­muno­genic­i­ty as­says to sup­port pre­clin­i­cal and clin­i­cal pro­grams. Learn more.

Bio­mark­er as­says

Ag­ilex Bi­o­labs iden­ti­fies the best as­say method­ol­o­gy to meet the clin­i­cal and reg­u­la­to­ry needs for each project, for each client.

When you part­ner with us, we can sup­port your drug de­vel­op­ment with ei­ther our ex­ist­ing Bio­mark­er menu or de­vel­op and val­i­date a suit­able as­say for your par­tic­u­lar re­quire­ments.

Ag­ilex Bi­o­labs has an ever-grow­ing menu of bio­mark­er as­says, in­clud­ing more than 300 val­i­dat­ed as­says.
Learn more.

Con­tact the team at Ag­ilex Bi­o­labs.

Or meet us at up­com­ing con­fer­ences in­clud­ing Biotech Show­case and OCT Cal­i­for­nia – West Coast.