Development

Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.

Sharing of bioprocessing know-how can help resolve pressing industry problems.

The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

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

GlaxoSmithKline and 23andMe, a personal genomics and biotechnology company, will partner to research and develop new drugs using human genetics.

The changing regulatory and manufacturing environment is ushering in a new approach to drug development.

The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

MilliporeSigma targets emerging biotechs with US development center and global grants.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

Vetter anounced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.

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.

FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.

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

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.