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Life Sciences

Delnova Unveils Partnership With Pace® Life Sciences To Boost Capabilities

DelNova’s partnership will enable clinical development of its lead candidate ReViVox® for the rescue of undesirable outcomes which may arise from a botulinum neurotoxin (BoNT) treatment such as Botox®. Pace® Life Sciences provides a full suite of contract CMC development, clinical trials materials manufacturing, and regulatory compliance, services to the biopharmaceutical industries. SAN DIEGO, Oct. […]

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Antibody Drug Candidates

Custom Approaches to Antibody Drug Conjugates Targeted therapeutics, including antibody-drug conjugates (ADCs) and polymer-drug conjugates, represent a growing market segment, but face unique challenges during research and development due to their structure and complex chemistries. Despite advances in protein engineering, conjugates are highly heterogeneous. Intrinsic heterogeneity significantly affects the complexity of the discovery and development

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Lipid Nanoparticles

Leverage Lipid Nanoparticles for Drug Delivery in Your Formulation Ensure your nucleic acid cargo is well protected and appropriately delivered with our lipid nanoparticles (LNPs) support services. LNPs are common delivery methods to administer nucleic acid-based therapeutics and are compatible with multiple routes of administration, including intravenous, subcutaneous, and inhaled. These molecules protect nucleic acids

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Drug Product Characterization

Characterization of Nucleic Acid Drug Products As nucleic acid therapeutics rapidly evolve; your development program may require innovative strategies tailored to these specialized products. Our experience spans various types of nucleic acid-based drug products, including high-concentration oligonucleotide formulations, lipid nanoparticles (LNP), virus-like particles (VLP), viruses, and other nanoparticle formulations. Within this dynamic landscape, gaining a

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Liquids and Suspensions

Experienced Clinical Manufacturing of Biologic Solutions & Suspensions Fulfill your clinical supply needs by partnering with our team for biologic solution and suspension manufacturing. We tailor our solutions to your specific requirements, whether you have established compounding processes and sterilization procedures or need support in developing sterile, scalable processes and formulations. Our GMP facilities are

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Solids and Semi-Solids

Flexible Biologic Semi-Solid & Solid Dose Manufacturing As biologics gain an increasing market share, they take many forms and present unique challenges compared to general pharmaceuticals. Utilize our team’s years of experience to fulfill your biotherapeutic clinical supply needs and address arduous obstacles. We offer solutions customized to your current progress, whether you have outlined

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Long-Acting Injectables

Agile Clinical Manufacturing of Injectable Biologics Navigate the complexities of sterile injectable manufacturing with confidence. Our team has the expertise and equipment needed to ensure regulatory compliance and meet your clinical supply demands for injectable biologics. Together, we’ll overcome the common manufacturing challenges, keeping your program’s progress on track. Whether your modality is a protein,

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Aseptic Fill

Reliable Fill-Finish Manufacturing of Biologic Clinical Supplies Manufacture your GMP clinical supplies with confidence when you partner with our team. No matter your modality, be it a protein, peptide, vaccine, or mAbs, our team has the expertise, infrastructure, and resources to fulfill your clinical supply needs. We offer solutions customized to your current progress, whether

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Enteric Protection

Enteric Coating Process Development Control the release of your biologic by coating the intermediate drug product with protective layers called enteric coating. These coatings inhibit the release of your biotherapeutic in low pH environments where they are vulnerable to degradation and agglomeration. Our team identifies the appropriate enteric coating for your biologic and prepares your

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Purification-UF/DF

Purification Processes & UF/DF Prepare your biologic for advancement with downstream ultra filtration (UF) and diafiltration (DF) purification processes. Whether your project requires a one-off buffer exchange to support early-stage formulation development or a full-scale process development endeavor intended for transfer to GMP facilities, our team prepares your manufacturing and fill finish processes to optimize

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