Formulation and Drug Delivery, Biologic Drugs

Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.

Researchers in China are playing a role in advancing gene therapy development.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

Wearable and smart devices allow user-friendly subcutaneous drug delivery.

Nanobiotix has launched Curadigm, a spinoff company that will specialize in developing a nanotechnology platform for healthcare applications.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Intertek has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, UK, through the acquisition of a new 20,000 sq. ft facility.

Patient-centric drug development is becoming more important in the bio/pharma industry.

Intracellular strategies offer an effective alternative approach to deliver a range of therapeutic proteins.

Alcami Biologics formed to meet market demands for biological drug development services.

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.

Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.

Lonza and Takeda have furthered their multiproduct partnership through collaborative efforts on a new cancer treatment-Alunbrig (brigatinib).

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.

Single-use technologies, modular systems, and robots are on the rise.

The acquisition of Juniper expands and strengthens Catalent’s offerings in formulation development, bioavailability solutions, and clinical-scale oral dose manufacturing.

The companies will collaborate to bring InnoCore Pharmaceuticals’ proprietary SynBiosys biodegradable polymer platform to market.

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.

Naturally occurring and engineered albumins are being explored as a tool to enhance the stability of drugs, including biologics, and extend shelf-life.

Lonza announces addition of mid-scale biologics manufacturing capacity and cell-therapy suites at Portsmouth, NH site.

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

The high viscosity of highly concentrated monoclonal antibody formulations not only presents processing and storage difficulties, but also formulation and delivery challenges.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

The company is developing a pipeline of combination therapies using its patented polymer-based matrix delivery system, known as TAOS (targeted orchestrated signalling matrix).

Graham Reynolds, vice-president and general manager, Global Biologics at West Pharmaceutical Services, Inc., shares insights on key considerations when developing a biologic drug product in a prefilled syringe.

Orbis Biosciences’ Optimµm Platform delivers microparticulate dosage forms with controlled-release and taste-masked properties in a single manufacturing step.