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As the number of new companies in biopharma continues to grow, so does their demand for outsourcing at every level of biopharmaceutical development.
Released By Scorpius BioManufacturing
A global pandemic magnified the need for more biologics manufacturing capacity. Capacity, however, isn’t the whole story.
What is a culture of quality, and how do you know if a biologics CDMO can earnestly make this claim?
Samir Lakhashe, Director, Bioanalytical Sciences, discusses assay categorization, the company's growing toolbox, predictions for the future, and more.
The demand for biologic drugs continues to grow at a steady 12–14% annually.
100 subject matter experts were surveyed from smaller biotech innovators to gain insight into the dynamics and drivers of the current biologics market.
Clinical manufacturing of cGMP-compliant mammalian cell culture processes is a complex and resource-intensive effort that presents several challenges.
Biologics process development is an active undertaking that seeks continuous improvement along the entire length of the drug development timeline.
A look at a CDMO’s value throughout a monoclonal antibody (mAb) therapeutic's lifecycle.
The value biologics CDMOs provide their innovator customers has changed radically in recent years, presenting new questions that must be answered.
The biologics CDMO selected for a given product or program is critical to an innovator’s ability to deliver a drug product safely, on time, and on budget.
When selecting a biologics CDMO partner—whether you need mammalian or microbial capabilities—the decision-making process follows a similar process.
Why Fina Biosolutions partnered with Scorpius Biomanufacturing for cGMP production of Ecocrm® (CRM197)
While crafting a RFP to capture the information innovators need to select a CDMO partner has always been critical; it has grown increasingly complicated.
The partnership includes recovery and downstream process optimization, analytical method implementation and phase-appropriate validation, and more.
Flexible, responsive, customized services for taking a program from R&D into the clinic, using American facilities and American sourced materials and equipment.
Delivering consistent and scalable mammalian-derived products, Scorpius uses its American facilities to advance your drug from R&D to the clinic and beyond.
Scorpius’ team has extensive experience in E. coli microbial biomanufacturing, including hard-to-work-with inclusion bodies.
Utilizing American-made equipment and reagents, Scorpius develops custom assays to profile your molecule and test your clinical trial samples.
Process development & cGMP contract manufacturing for biologics and cell therapies.
The collaboration integrates LenioBio’s cell-free protein expression platform with Twist’s DNA manufacturing and automation capabilities.
By: Patrick Lavery
Rengis brings extensive international leadership experience across pharmaceutical manufacturing, R&D and CDMO operations.
By: Charlie Sternberg
How today’s manufacturers are filling the growing need for biologics without rushing complex processes in development or quality control.
By: Kristin Brooks
Advantages of integrated, QbD-guided formulation development services and key strategies for minimizing risk and maximizing success.
By: Eliza Yeung
Integrated approach simplifies development, reduces risk, and supports scalable manufacturing.
How Pfizer CentreOne helps customers navigate complexity in OSD manufacturing through a consistent network and targeted technical expertise at the site level.
Released By Pfizer CentreOne
As trade policy, regulatory scrutiny, and capital discipline reshape biologics development, sponsors are rethinking where and how commercial manufacturing is secured. Bora Biologics’ recent U.S. expansion and validated 2,000L scale-up reflect a broader shift toward demand-aligned, inspection-ready commercial capacity in the markets where products will ultimately be supplied.
Released By Bora Biologics
There are many reasons for a pharmaceutical company to perform a tech transfer to a contract manufacturing organization (CMO).
Released By AbbVie Contract Manufacturing
Epicrispr’s investigational gene therapy, EPI-321, is a treatment for facioscapulohumeral muscular dystrophy.
The companies will use Cellular Origins’ automated mobile robotic platform.
The new line of high-clarity PETG bottles is designed to support the demanding requirements of pharmaceutical and biopharmaceutical manufacturing environments.
The collaboration combines HAS Group’s expertise in complex bioconjugation, process development, and clinical-grade manufacturing with Biodelphis Therapeutics’ APIC platform.
Will further advance U.S.-based production capacity, enhance next-gen technologies and support a reliable supply of medicines for patients.
The partnership will work to advance Novelty Nobility’s bispecific antibody drug candidate through process development and GMP manufacturing.
Offers a scalable platform from small process development batches to larger cGMP manufacturing runs.
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