Biologic Drugs

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.

With the acquisition, Orgenesis will combine TamirBio’s ranpirnase antiviral platform with its Bioxome technology.

The partners have formed a joint venture to produce muscle-derived mesenchymal stem cells as a source of exosomes and other cellular products to develop related therapies and advance clinical trials.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.

The new center expands the company’s R&D capabilities and will help it advance its portfolio of rare disease gene therapy programs.

Research from data and analytics company GlobalData shows that CAR-T cell therapy innovations across APAC will make the global market for these therapies more competitive.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.

The huge potential of biopharma is presenting an important epoch for outsourcing partners that can support the development and manufacture of biologics in an efficient way.

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

The license gives Daiichi Sankyo access to ERS Genomics’ genome-editing technology for internal R&D initiatives.

Otsuka will use PhoreMost’s phenotypic screening platform to identify new targets for drug development, with a focus on gene therapy.

The agency has published seven guidance documents directed at the development and manufacture of gene therapies.

GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022.

The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

Under the agreement, Almirall will leverage WuXi Biologics’ proprietary WuXiBody platform to develop bispecific antibodies for dermatological diseases.

The joint venture will develop next-generation cell and gene therapies incorporating Affimer proteins.

Roche will apply ProBioGen’s proprietary GlymaxX technology to boost the antibody-dependent cellular cytotoxicity activity of antibodies.

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

Visualization using virtual and mixed reality can aid with biopharma manufacturing facility design and training.