Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Emerging Therapies Drive Analytical Advancements

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Analyzing Exabytes

Effective analytics will eliminate failures, deviations, and non-conformances.

Best Weighing Practices in the Pharmaceutical Industry

November 22, 2017

PTSM: Pharmaceutical Technology Sourcing and Management

Understanding what affects a measurement and implementing appropriate procedures will aid weighing accuracy.

Samsung Bioepis Receives Approval for First Trastuzumab Biosimilar, Ontruzant, in Europe

November 20, 2017

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

FDA Approves Roche’s Hemophilia A Biologic and Expands Indication for Leukemia Drug

November 20, 2017

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

Integrated Analytical Software Solutions for Clinical and Regulatory Processes

November 17, 2017

PTSM: Pharmaceutical Technology Sourcing and Management

MasterControl has added three new cloud-based analytical solutions to its MasterControl Version 11.7 software for clinical managers and regulatory/submissions professionals.

J&J and Zymeworks in Bispecific Antibody Pact Worth Nearly $1.5 Billion

November 16, 2017

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

Pall Debuts New Inline Diafiltration Modules for Continuous Bioprocessing

November 16, 2017

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

Therapeutic Vaccines Target Cancer and Other Viral-Induced Diseases

November 15, 2017

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.

Nitto Avecia Completes Large-Scale Synthesis of Oligonucleotide

November 13, 2017

PTSM: Pharmaceutical Technology Sourcing and Management

Company completes first successful run of what is believed to be the largest synthesis-scale done for oligonucleotide APIs.

WuXi and Pall Establish Continuous MAb Manufacture

November 13, 2017

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic

November 10, 2017

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.