In the Lab

Taking a Holistic Approach for Data Governance

As regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.
/ read more /

Does Your Endotoxin Detection Method Ensure Patient Safety?

Understanding the relative strengths and weaknesses of different endotoxin test methods is crucial to maintaining quality and patient safety.
/ read more /

Biosimilars Raise Analytical and Policy Challenges

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.
/ read more /

Best Weighing Practices in the Pharmaceutical Industry

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

Integrated Analytical Software Solutions for Clinical and Regulatory Processes

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

Excipients

Improving Taste to Enhance Medication Adherence

Formulation and excipient advances address taste masking concerns to improve medication adherence in pediatric, geriatric, and other special patient populations.
/ read more /

Outsourcing Update

CDMOs Add Capabilities to Build Strategic Biopharma Capabilities

Acquisition activity has created some CDMOs with facilities and capabilities that rivals global bio/pharma companies.
/ read more /

Supply Chain

Will Pharma Meet the Drug Tracking Deadline?

Manufacturers and trading partners struggle to meet drug tracking requirements.
/ read more /

Contract Services Update

Lonza in Gene Therapy Licensing Agreements

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.
/ read more /

Recipharm Equips Three More Facilities for US Serialization

The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, are the latest of Recipharm's sites to be equipped to supply serialized products to the United States.
/ read more /

Avista Doubles API Manufacturing Capacity at Colorado Facility

Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.
/ read more /

Cambrex Expands Small-Scale Capacity at Iowa Facility

The company has completed a small-scale capacity expansion at its site in Charles City, IA.
/ read more /

Nitto Avecia Completes Large-Scale Synthesis of Oligonucleotide

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

Alcami in API Manufacturing Pact with Solasia

Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.
/ read more /

QuintilesIMS Changes Name to IQVIA

QuintilesIMS has changed its name to IQVIA to reflect its October 2016 merger with IMS Health.
/ read more /

Vetter Expands in Asia-Pacific

The company has officially opened a local branch office in South Korean to support its existing business in the region.
/ read more /