THERAPEUTICS DEVELOPMENT

Cell Line / Strain ___________

Premas offers microbial, _____ and mammalian platforms to ______ the expression of therapeutic ________ with varied needs of ____-_____________ modifications and complexity of ___ protein.

Premas combines significant product ___ process development knowledge to ______ the target strain and ________ vector combinations. Premas ___ developed novel signal sequences ___ periplasmic and extracellular expression (_________) for therapeutics. We ____ also performed a number __ studies to change Inclusion ____ expression to periplasmic expression. ____ has allowed for a ____ to IND of metabolic ________ IND therapeutic protein in 9 months.
Yeast Strain, Pichia pastoris and Saccharomyces cerevisiae – the platform technologies with _______ and strains have been ____ developing certain class of ____________ in Pichia. On the _____ hand, targets and critical ________ have been produced using ___ Saccharomyces strains. Along with ____ than 20 different vectors ___ the expression of proteins, _____ technologies have been highly __________ in the expression and ______ of proteins.
CHO/HEK platforms: Premas has ___ own platform technology to ________ human antibody library. The ___ DG44 cell line works ____ with our proprietary mammalian __________ vectors, which have been ________ for high-level stable expression __ mammalian hosts. The growth ___ production properties of our ___-__44 cell line are well _______, and the feed strategy ___ been optimized, allowing for ______ and more efficient scale-up __ bioreactors. We have observed ____ level expression of antibodies ___ litre level using this ____ line and our therapeutic __________ have reached preclinical stage _______ very encouraging results.

Process Development

Process development at ______ covers a significant broad ________ of R&D activities coupled ____ various input parameters based __ in silico analysis, real-world evidence ___ analytical data. Process development _________ with significant clone development __________; which then is concomitantly ______ up from shake flasks, __ small scale bioreactors (0.5-2.0L) ___ subsequently into 5L-50L-500L-1100L capacities.

Our upstream process ___________ group develops high cell _______ E. coli batch, fed-batch ___ semi-continuous processes for therapeutic ___________ proteins. This group interacts ____ the strategy and clone ___________ groups from the initiation __ the project. This allows ___ the final objective to _______ evident and visible to ___ PD group and subsequent __________ and manufacturing groups. COGS, ___ process simplicity is one __ our target hallmarks of _______ with Premas.

Monoclonal antibodies and _________ derived proteins, produced from _________ cell cultures are process _________ with similar thoughts. Our ________ is flexible, partnership based _______ our clients’ needs. ____ bioreactors (5-25L) and Single ___ (1-10L) constitute the first ____ of process development and _______ up. Gram level yields __ the clone /shake flask ______ are enhanced with media ___________, optimizing feed strategies, upstream _______ development and multi-parametric inputs ___ controls.

Our downstream process ___________ team has delivered over >650 proteins, of which about 100’_ of them have ____ scale up to > 100_ culture volumes. With unit __________ scalable to 1000’s of _____ of product, harvesting and _____________ steps have significant capacities, __________, and access to multiple _______, e.g. high speed continuous ___________, concentrations and diafiltrations systems (1000’_ of Liters), both cassette ___ hollow fiber based systems.

Chromatography systems and ______ defined process protocols exist __ Premas. With the vast __________ of over 14 years, ______ has developed unique scale ____ models (ml to 100’sof _) and processes to rapidly ________ on possible steps, yields ___ outcomes. (Reference: Application Note: ____ to Phase 1 material __ 10 months). Use of _____-_____ components and analysis, Premas ___ been able to deliver ____ of the significantly challenging ________ and processes at low ____.

Further downstream process ___________ is possible at Premas _____ we develop high protein _____________ formulations and lyophilization cycles. ______ has both small and _____ scale development lyophilizers.

Scale Up and _____________

Premas has multiple _____ and suites dedicated to ________ and downstream processing technologies, _________ fully disposable single-use bioreactor _______. We are capable of _______ our customers’ demands on ____, flexibility and productivity. Processes ___________ from our PD labs __________ scale up in our _____-_____ GMP compliant facility. We ____ also successfully performed the __________ and registration of several 2__ and 3rd generation processes.

Our 24/7 running ____ of our processes enable __ to design semi-continuous processes, __________ operations and significantly lower ____ processes. We developed different ____________ and processes to offer ___________ advantages to a number __ new molecule formats and _____________ processes. Some of the ________ include a concomitant increase __ productivity as well as __________ purification, along with low ____.

Premas has the ________ to deliver grams to ___ product and drug substance. __ have now for a __________ product line expanded our ________ to 5kg/week delivery schedules.

This allows Premas __ accelerate development of our ________’ product pipeline and enable ________ deliveries for their clinical ______ in various geographies. We ____ been audited by various __________ and regulatory consultants and _______ assurance groups of our _________.

APPLICATIONS

Bound-less Bio-tech