Tyler Jones

The number of FDA-approved monoclonal antibodies (mAbs) continues to grow, while those in late-stage development rose more than 30% between 2021 and 2022. Given the relative value of being first to market, biopharmaceutical companies are looking to shrink the 10 or more years it usually takes for a biologic candidate to progress from drug discovery to regulatory approval.

Increase speed, reduce risk and maintain quality of mAbs by partnering with a CDMO that has a comprehensive program… Show more

The number of FDA-approved monoclonal antibodies (mAbs) continues to grow, while those in late-stage development rose more than 30% between 2021 and 2022. Given the relative value of being first to market, biopharmaceutical companies are looking to shrink the 10 or more years it usually takes for a biologic candidate to progress from drug discovery to regulatory approval.

Increase speed, reduce risk and maintain quality of mAbs by partnering with a CDMO that has a comprehensive program for moving from discovery to clinical batches of a new biologic.

Rapid antibody discovery process
Cell line development using CHO-GSN℠ platform
Cell bank generation and characterization with Solentim® VIPS™
Upstream process development using Sartorius® Ambr® 15 Cell Culture Bioreactor System for optimized culture conditions
Downstream process development
Drug product formulation development and manufacturing
Identifying critical quality attributes (CQAs)
Quality systems at Curia
Specializing in First-to-Human manufacturing support Show less

The clinical value of biologics for the treatment of many disease indications has been accompanied by phenomenal sales. By 2026, the global market for biologics is projected to increase to $537 billion. However, getting a promising drug candidate from formulation development to clinical phase production and commercial manufacturing can be daunting. Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill-finish is successful.

Protein-based therapeutics have experienced monumental growth over the past few decades and are expected to continue to accelerate in the coming years. In 2018, the global demand for therapeutic proteins was estimated at around $93 billion and is projected to rise to $172 billion by 2022 at a CAGR of 16.7%, according to data from market research store Research and Markets. To gain a competitive advantage, such as patient self- administration utilizing injection devices, convenient storage… Show more

Protein-based therapeutics have experienced monumental growth over the past few decades and are expected to continue to accelerate in the coming years. In 2018, the global demand for therapeutic proteins was estimated at around $93 billion and is projected to rise to $172 billion by 2022 at a CAGR of 16.7%, according to data from market research store Research and Markets. To gain a competitive advantage, such as patient self- administration utilizing injection devices, convenient storage, etc., high concentration protein therapeutics have become a recent focus in the field. Higher concentrations, however, present a variety of unique challenges for formulation development. While proteins generally exhibit good solubility in an aqueous environment, elevated concentrations are known to contribute to high viscosity, irreversible precipitation, and aggregation (soluble and insoluble). These properties affect various aspects of the product including stability, injectability, and manufacturability.
Limitations on concentration have further consequences with respect to dosage, and often, high dosage therapeutics must be given over multiple injections, reducing patient adherence. Efficient and accurate identification of relevant, product-specific challenges helps facilitate effective formulation strategies. Understanding these challenges begins with preformulation characterization, in which critical quality attributes are identified through early formulation work. Aspects such as stress factors, degradation products/pathways, stability-indicating assay development/confirmation, and formulation parameters are explored, and data is generated supporting a stable formulation space. Often, this is performed at lower concentration and much of the information collected is beneficial prior to high concentration studies. High concentration formulation development is then performed on leading formulation candidates and additional challenges are identified that are relevant to the... Show less

Pathogenic cryptococci are encapsulated yeast that can cause severe meningoencephalitis. Existing therapeutic options are dated and there is a growing need for new alternative antifungal agents for these fungi. Here we report novel inhibition of pathogenic cryptococci by the antimicrobial lectin Scytovirin. Inhibition was most potent against C. neoformans var neoformans and C. gattii, with MFC values of 500 nM. Scytovirin binding was localized to the cell wall and shown to affect capsule size… Show more

Pathogenic cryptococci are encapsulated yeast that can cause severe meningoencephalitis. Existing therapeutic options are dated and there is a growing need for new alternative antifungal agents for these fungi. Here we report novel inhibition of pathogenic cryptococci by the antimicrobial lectin Scytovirin. Inhibition was most potent against C. neoformans var neoformans and C. gattii, with MFC values of 500 nM. Scytovirin binding was localized to the cell wall and shown to affect capsule size and release. No effect was observed on melanization or with cells grown in the presence the cell wall stressor Congo red. Synergy which existing antifungals was indicated, most strongly for amphotericin B. Overall, Scytovirin serves as a much needed new avenue for anticryptococcal development. Show less

High mannose-binding lectins have long been studied for their potent antiviral activity. Among these lectins, Scytovirin, a small 9.5 kDa protein from the cyanobacterium Scytonema varium, is distinctive for its lack of extended secondary structure, potent antiviral efficacy, and benign safety profile. Recently, our lab has extended the application of Scytovirin inhibition to numerous pathogenic fungi including Cryptococcus neoformans. Through broth macrodilution testing, we found minimum… Show more

High mannose-binding lectins have long been studied for their potent antiviral activity. Among these lectins, Scytovirin, a small 9.5 kDa protein from the cyanobacterium Scytonema varium, is distinctive for its lack of extended secondary structure, potent antiviral efficacy, and benign safety profile. Recently, our lab has extended the application of Scytovirin inhibition to numerous pathogenic fungi including Cryptococcus neoformans. Through broth macrodilution testing, we found minimum inhibitory concentration values in the sub-micromolar range. To further understand how this lectin inhibits fungi, we searched for proteins similar to Scytovirin. A Scytovirin-like domain, Myxovirin, was found between an N-terminal signal peptide and beta-trefoil motif similar to that of the Ricin B chain in the genome of the proteobacteria Myxococcus fulvus. Myxovirin shares 72% amino acid sequence identity (28 of 39 identical residues) and 87% homology to the C-terminal carbohydrate binding domain of Scytovirin.
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