Biologic Drugs

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

The partnership aims to provide end-to-end development and manufacturing for biopharmaceutical drug substance and drug product.

The company’s presentation at ASGCT includes preliminary data results for a child who received the gene therapy.

A greater understanding of molecular and cellular biology and technological advancements are revolutionizing the field of biologics.

Technological advances are helping advance biologics development and manufacturing and reduce bottlenecks.

Packaging and packaging line innovations are addressing the industry’s growing use of biologics.

Activation and expansion are essential for success in both autologous and allogeneic therapies.

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

MediWound has been granted an additional $6.7 million by the DoD to advance NexoBrid as a non-surgical field care solution for the US military.

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

Tumour-infiltrating lymphocyte (TIL) therapies offer a new route to target cancer.

WuXi XDC will provide end-to-end services to support Boostimmune’s discovery of novel bioconjugates.

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

A partnership between Rentschler Biopharma and Ikarovec will support the accelerated development of novel gene therapies for the treatment of eye diseases.

The market potential of nucleic acid-based therapies have been pushed into the spotlight following the success of the COVID-19 vaccines.

E&L analytical testing methods can be determined through pointed consideration of the differences small- and large-molecule drug products.

Despite the advantages intensified processes can offer developers, there are still some obstacles to overcome before broader application of new technologies will be implemented.

Alternative approaches to freeze-drying are gaining popularity and will help to overcome some of the challenges associated with conventional lyophilization.

Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.

Webinar Date/Time: Tue, Apr 4, 2023 11:00 AM EDT

Webinar Date/Time: Thu, Mar 30, 2023 11:00 AM EDT

In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.

Efforts to optimize the delivery of sensitive biotherapeutics continue to evolve.

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?