09.14.26 -- ATMP Development Gets A Boost From Outsourcing Best Practices

Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.

Early CMC and expression system decisions in recombinant protein development shape quality, cost, and manufacturability, while collaboration helps avoid bottlenecks when scaling to production.

Discover how solvent‑free, solid‑state stress testing speeds degradation studies, yields realistic impurity profiles, and provides earlier, material‑efficient insight into drug stability and risk.

Evaluating fill-finish CDMOs beyond cost and capacity ensures long-term success. Strategic focus on technical depth, scalability, and modern compliance reduces risk.

To support regulatory confidence, a biopharma company evaluated whether manufacturing changes affected its monoclonal antibody's higher-order structure.

Predict immunogenic risks in peptides with unnatural amino acids using in silico workflows. High-accuracy simulations predict HLA binding to accelerate safety assessments and regulatory approvals.

Digital twins replace startup surprises with operational confidence by integrating facility engineering, validation, and operational data into one connected model during capital project execution.

See how existing partnerships with NIH allowed the chance to bring together government, academic, and industry resources through strategic initiatives that streamline processes and maximize benefits.

Learn how leveraging a customs warehouse can streamline your supply chain, reduce VAT costs, and enhance global compliance and efficiency.

Integrating R&D knowledge into GMP documentation ensures aseptic powder fill‑finish processes by capturing material insights, defining controls, and enabling knowledge‑driven manufacturing.

Europe’s integrated CDMO model is reshaping biologics development by aligning early science, manufacturing, and quality to accelerate scalable, compliant therapies from concept to clinic.

An experienced industry leader shares insights on how biosimilars are reshaping healthcare through scale, manufacturing discipline, supply reliability, and long‑term commercial strategy.

As capacity expands and capabilities mature, CDMOs with global scale and advanced injectable expertise are becoming critical partners for bringing complex sterile drug products to market.

View an autoinjector platform that supports ANDA pathways with demonstrated usability and design alignment to help development teams reduce risk and move confidently toward regulatory submission.

Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.

Understand why this area is poised to become a leading hub for cell and gene therapy, as highlighted by CCS and industry experts at the 6th Annual Supply Chain Summit.

A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the mAb impacts the overall behavior of the drug product.

Uncover a genetic stability assay that is fully validated to GMP quality standards and outperforms traditional testing methods with its enhanced speed and accuracy.

Watch how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.