Life Sciences

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 […]

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

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

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,

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

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

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

Injectable Formulation Development Developing injectable formulations presents challenges in ensuring biologic stability at therapeutic doses and seamless compatibility with devices and administration. To overcome these obstacles, we prioritize safeguarding your biotherapeutics stability and solubility, creating a product that best serves your patient population and market opportunity. Achieve targeted drug delivery with our team’s expertise in

In-Use Clinical Compatibility Test the compatibility of your materials and equipment with your biotherapeutic to ensure dosing and limit immunogenicity concerns prior to patient administration. Our team addresses many factors that impact in-use compatibility, such as varying materials used in IV bags, tubing, syringes, and filters. Other factors, such as chemical composition and manufacturing processes,

Enhanced Solutions & Suspensions Formulations Elevate your biological formulation with the optimal solution or suspension dosage forms for your product. We know first-hand the importance of amplifying a compound’s potential, researching every avenue for optimal responses, and delivering a gentler dosing experience your end customers deserve. Even if your biologic or large molecule is difficult