METAVAX®


mod­el of duck hepati­tis B virus (45nm)

ARTESMETAVAX® plat­form is designed for the devel­op­ment of high­ly immuno­genic sub­unit vac­cines in human and ani­mal health. It is based on enveloped virus like par­ti­cles (VLP) derived from the recom­bi­nant sur­face anti­gen of the duck hepati­tis B virus (dS) as scaffold.

METAVAX® sup­ports effi­cient expres­sion, fold­ing and pre­sen­ta­tion of the tar­get anti­gen on the sur­face of virus-like par­ti­cles. The result­ing chimeric VLP enhances recog­ni­tion and uptake by anti­gen pre­sent­ing cells and results in a potent immune response against the tar­get anti­gen. Com­bined with ARTES’ yeast expres­sion plat­form Hansenu­la poly­mor­pha, it builds a con­vinc­ing approach for eco­nom­ic pro­duc­tion of safe and effi­ca­cious vaccines.

Adju­vant-free vac­cine can­di­dates address­ing dis­eases like avian and swine flu, malar­ia and HIV have been test­ed in pre­clin­i­cal stud­ies and were found to be safe, gen­er­al­ly well tol­er­at­ed and high­ly immunogenic.

The tech­nol­o­gy plat­form is well estab­lished in dif­fer­ent cus­tomers’ ani­mal vac­cine devel­op­ment projects.



METAVAX® at a glance:

  • well suit­ed for human and vet­eri­nary vaccines
  • pre­sen­ta­tion of large tar­get anti­gens and con­for­ma­tion­al epitopes
  • ver­sa­tile expres­sion of tar­gets as e.g. N- or C‑terminal fusion proteins
  • rapid fea­si­bil­i­ty stud­ies by gener­ic process­es and analytics

Manufacturing



Tech­ni­cal experts are involved right from the start of the project and remain involved dur­ing process trans­fer and pro­duc­tion. This ensures a smooth tran­si­tion from the project’s ear­ly phase up to com­mer­cial scale.



ARTES‘ offer includes:

  • opti­miz­ing and upscal­ing of fer­men­ta­tion and down­stream processes
  • non-GMP man­u­fac­tur­ing of test and pre-clin­i­cal material
  • cGMP man­u­fac­tur­ing
  • qual­i­ty control
  • trans­fer of ana­lyt­i­cal methods
  • trans­fer of documentation
  • pro­fes­sion­al project management

Technology Transfer


A range of bio-sim­i­lar and recom­bi­nant pro­tein prod­ucts and process­es is avail­able at ARTES for out-licens­ing and tech­nol­o­gy trans­fer. With train­ings or on-site sup­port we assist our clients to imple­ment the process­es in their own labs respec­tive­ly plants.

We trans­fer licens­es on our intel­lec­tu­al prop­er­ty (IP) and know-how, on cell lines and on our devel­oped processes.

For out-licens­ing we mutu­al­ly agree with our part­ner on the terms and con­di­tions in a case by case busi­ness mod­el: non-exclu­sive or exclu­sive, region­al or glob­al licens­es, lump-sum pay­ments or mile­stone based payments.

Togeth­er with our client we find out the most effi­cient model.

Process Development



The fer­men­tation process is one of the major cost dri­vers in indus­tri­al pro­duc­tion. The fer­men­ta­tion process­es devel­oped at ARTES are based on low-cost, ful­ly syn­thet­ic media avoid­ing expen­sive addi­tives (e.g. methanol or IPTG) and aim­ing at short pro­duc­tion times (approx. 45 – 75 hrs. for yeast; approx. 24 hrs. for E. coli). High pro­duc­tiv­i­ty obtained with ARTES´ tech­nolo­gies direct­ly trans­lates into sav­ings in ener­gy, invest­ment, con­sum­ables and waste.

Up- and down­stream process devel­op­ment is designed right from the start to meet cGMP and large scale require­ments in lat­er-on rou­tine man­u­fac­tur­ing. Spe­cial empha­sis is giv­en on repro­ducibil­i­ty and cost reduc­tion. In-process con­trol and final char­ac­ter­i­za­tion of the prod­uct and of host/process relat­ed impu­ri­ties are includ­ed in our process devel­op­ment. If applic­a­ble, this char­ac­ter­i­za­tion is per­formed accord­ing to inter­na­tion­al pharmacopoeia.

ARTES pro­vides to the client the full set of doc­u­men­ta­tion nec­es­sary to trans­fer the process to his man­u­fac­tur­ing site or to a CMO. Prod­uct sam­ples gen­er­at­ed and arms-length assis­tance in the trans­fer of the process devel­oped are added to our offer.

cGMP com­pli­ant method devel­op­ment and rou­tine analy­ses can be con­tract­ed with ARTES as well and will be pro­vid­ed in close col­lab­o­ra­tion with our indus­tri­al partners.

Large scale man­u­fac­tur­ing (nonGMP and cGMP) can be con­tract­ed as well and will be per­formed at ARTES or at our part­ner facilities.



ARTES´ offer includes:

  • fer­men­ta­tion process development
  • down­stream process development
  • in-process and qual­i­ty con­trol assay development

Cell Line Development



The focus of our tai­lor-made offer is on micro­bial pro­duc­tion cell lines based on yeast (Hansenu­la, Pichia and Sac­cha­romyces) and bac­te­ria (E. coli). To meet cus­tomer’s demand,  ARTES Biotech­nol­o­gy devel­ops the most effi­cient solu­tion for the tar­get of choice. 

A trans­par­ent, well defined project design is agreed with our client pri­or to the start of the project, defin­ing deliv­er­ables, time­lines, mile­stones, Go/No-go deci­sion points and costs.

A typ­i­cal project starts with new­ly syn­the­sized genes opti­mized for the respec­tive host and pro­vid­ing a well defined ori­gin for lat­er reg­is­tra­tion. With­in 6 – 8 weeks a first answer on fea­si­bil­i­ty of expres­sion and pro­tein local­iza­tion is deliv­ered and a mutu­al deci­sion is tak­en on the progress of the cell line devel­op­ment. Next steps may include opti­miza­tion of expres­sion and/or secre­tion, gen­er­a­tion of sta­ble cell lines, selec­tion of pro­duc­tion cell line(s) for trans­fer to the client resp. for fur­ther process devel­op­ment at ARTES, genom­ic char­ac­ter­i­za­tion and pre­lim­i­nary high cell den­si­ty fermentation.



ARTES‘ offer includes:

  • fea­si­bil­i­ty studies
  • pro­duc­tion cell line development
  • cell bank gen­er­a­tion, char­ac­ter­i­za­tion and transfer