Drug Development

By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

Lonza has added four liver cell types to its hepatocytes portfolio for testing of in vitro drug models.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

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

Cambrex invests $5 million in new laboratory expansion at its Karlskoga, Sweden facility.

Bosch Packaging Technology will introduce its newest R&D device for continuous oral solid dosage production at Achema 2018.

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

Allergan will buy a potential depression treatment from Aptinyx.

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

ExcipientFest has been acquired by IPEC and rebranded as Excipient World.

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

The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.

Choice of carrier can have a significant impact on the capsule filling process as well as the performance of the DPI formulation.

Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.

A skilled workforce is needed to deliver on technology’s promising medical advances.

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

Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.

The company will add a new $5-million drug development center of excellence at its facility and headquarters in Somerset, NJ.