Discovery Research

FROM THE EDITOR

  • futuristic automation, artificial intelligence, smart manufacturing technology-GettyImages-2270354379
    AI And Data Pull CDMOs Into Pharma's Commercial Strategy

    The distance between external API producers and fill-finish experts, and the commercial apparatus of their pharma customers, has lessened. Commercial evidence now starts its derivation as innovation becomes tangible material, set processes, and then product creation … at external development and manufacturing partners. Jon Williams, CEO, Lumanity, says there's a shift toward integrating development strategy and commercial decision-making earlier in the lifecycle.

FDA Now A Supply-Chain Complication

Crossing the Rubicon to regulatory-leadership discontinuity; suffering a disunity at the FDA impacting our supply chains. When sponsors begin altering outsourcing relationships and clinical-trial strategies because of uncertainty at the FDA, more supply-chain challenges are created than corrected for. That suggests all of us should take a deep breath. Vigilance and concern are always part of the drug industry. But we need to address the question: How is the FDA impacting development and manufacturing outsourcing?

Why Is Biopharma Left Out Of The U.S. Infrastructure Conversation?

Investment manager BlackRock gathered powerful investors to discuss along with government officials the nation’s physical and economic backbone. The Infrastructure Summit clarified the biopharma industry including CDMOs are in a battle for investments and infrastructure. Analysis from Chief Editor Louis Garguilo.

AI Stuck Upstream? It Still Influences Manufacturing Outsourcing

AI may help run and optimize bioreactors at your CDMO. There is pervasive pressure to move manual (and reactive) control to AI-autonomous (predictive systems). You may already select your CDMO partially based on its systematic utilization of AI in its facilities. But at this moment of transition, while the odds are high AI may not fully reside in the manufacturing plant today, it increasingly shapes the decisions determining what and how programs get to that plant.

Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not

Tokyo Institute of Technology. London Business School. ETH Zürich. What do these institutions – and a biotech based in Mulhouse, France – have in common? Matthieu de Kalbermatten, CEO of CellProthera. His international experience adds up to this: Build an internal quality (cGMP) organization; become the master of the processes you create for your therapy, before moving to external help; then select your CDMO carefully – maybe just prior to Phase III.

More From The Editor

ARTICLES

More Articles

SERVICES AND PRODUCTS

GettyImages-1602744313 assay
Cell-Based Assay Development And Testing

Evaluating small and large molecule therapeutics within cellular environments is essential to understanding their efficacy, potency, and safety within a complex biological system.

drug-product-GettyImages-1293772880
Drug Metabolism And Pharmacokinetics (DMPK)

Curia’s DMPK scientists deliver expert solutions for your drug discovery programs. Providing bioanalytical methods development, in vitro ADMET testing and in vivo PK and PD services that span all stages of drug discovery up to candidate selection.

GettyImages-2189362114-recombinant-protein-structure
Protein Expression And Analysis

Curia’s expert scientists use advanced technology to produce and analyze high-quality recombinant proteins.

cmo-biologics-GettyImages-1327624070
Biologics Discovery

Make the most of your molecule with integrated antibody discovery, engineering, and production capabilities designed to accelerate lead identification and optimization.

GettyImages-2192786673 antibodies
Antibody Discovery And Engineering

The Antibody Center at Curia provides end-to-end services in antibody discovery, engineering, and development.

More Services and Products

SUPPLIER PROFILES

  • UPM Pharmaceuticals, Inc.

    UPM Pharmaceuticals, Inc. is a Baltimore-based, independent drug development and contract manufacturer serving the pharmaceutical and biotechnology industries.

  • Aptuit

    Aptuit is a pharmaceutical services company that delivers early to mid-phase drug development solutions by applying scientific excellence, outstanding service and a team of some of the foremost scientific professionals in the industry.

  • Aptuit, Inc. - drug development programs, pharmaceutical service Aptuit is a pharmaceutical service company that conducts research, development and manufacturing on a contract basis for both large and small innovators.
More Supplier Profiles

OUTSOURCED PHARMA NEWS

More From Outsourced Pharma News

ABOUT DRUG DISCOVERY RESESARCH

Outsourcing of drug discovery research helps pharmaceutical and biopharmaceutical companies find targets that cause or lead to specific disease and the compounds that might prove effective in treating the disease.  Chemical or biologic compounds are screened in the laboratory using specific assays and are tested against these targets to find leading drug candidates for further development.  Many scientific approaches are now used to determine targets, typically receptors or enzymes, and obtain the lead compounds.  These include the use of genomic and proteomic technology, synthetic chemistry, recombinant DNA (rDNA) technology, laboratory automation, and bioinformatics.

Drug discovery research is often broken into 4 stages: target identification & validation, lead identification, lead optimization, and candidate selection.  Discovery research services offered by Contract Research Organizations (CRO) include molecular imaging, In Vitro Assays, disease models, transgenic creation/phenotype, genomic analysis, and population genetics in the target ID & validation stage.  Lead identification services include HTS & secondary assays, assay development, protein expression systems, expression construct, in-silico screening, crystallography, computational modeling, and medicinal chemistry.

Testing during lead optimization includes efficacy models, discovery toxicity and pharmacology screening, DMPK, molecular & cellular analysis, bio analysis, transgenic studies, informatics, protein production & purification, hybridoma generation, rational drug design, and consulting services.  Finally, candidate selection is accomplished using pathology and histopathology, safety models, formulation analysis, and process chemistry & scale-up.