07.14.25 -- Biologics Development At CDMOs Demands More Flexibility

Chief Scientific Officer John Lin discusses the balance of art and science in topical formulation development, emphasizing advanced skin models for optimized delivery, activity, and product stability.

As protein-based therapeutics gain traction in the greater market, innovative techniques aimed at their optimization have become key drivers for the industry.

When evaluating a CDMO’s ability to deliver on time, review the elements that biopharma companies should consider to improve on-time delivery when outsourcing drug product manufacturing.

Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.

Discover a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

Optimizing product release requires effective planning, specification development, electronic systems, and collaboration with CMOs, ensuring compliance, efficiency, and quality.

Small-scale downstream studies play a critical role in enabling efficient, low-risk tech transfer by providing data-driven insights that ensure process robustness and support regulatory compliance.

Ensure the potency and efficacy of your biologic products with a GMP-compliant potency bioassay, offering accurate real-time assessments for GMP release and stability testing.

Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.

Laxxon Medical's proprietary Screen-Printed Innovative Drug Technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.

Explore the challenges and solutions in high-concentration monoclonal antibody manufacturing, which includes strategies for maximizing product recovery and optimizing processes for efficient production.

Equipped with advanced isolator and RABS technologies, our aseptic filling facilities feature multiple filling lines capable of producing liquid and lyophilized vials as well as prefilled syringes.

Follow along as Derek Ryan, Sr. Director of Analytical Development, showcases our high-throughput technology and digital tools for process understanding and optimizing decision-making.

Gain valuable insights into our mammalian development services, manufacturing solutions, upcoming capacity availability, as well as updates on expansion timelines for external clients.

This presentation highlights how simplified execution with development, filling, and analytics under one roof ensures safe, efficacious products reach patients in need.