Contract service providers must step up their game to stay competitive in increasingly complex bio/pharma market.

Pharmaceutical Outsourcing Present and Future

The need for preclinical testing expertise is growing as molecular complexity increases.

Navigating the Preclinical CRO Outsourcing Process

A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.

A Closer Look at Affinity Ligands

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Articles

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.


Cambrex Adds Reactors to Facility in Sweden

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

ADC Bio Invests $11 Million on Bioconjugation Facility

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Ajinomoto Althea Adds High Potency Capabilities

The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply. 

Catalent to Acquire Cook Pharmica for $950 Million

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report.

Matching the production requirements of a bio/pharma company with the manufacturing capabilities of a CMO is a delicate balance, requiring attitude shifts on both sides of the table.


Flexibility and Innovation Needed to Solve Manufacturing Uncertainity

Natalia Belikova, PhD, is analytical services director at SGS Life Sciences, Lincolnshire, IL.

Hildegard Bruemmer, PhD, is operational laboratory manager at SGS Life Sciences, Germany. 

Forced degradation studies can identify stability problems for drug substance and drug products.

Stepping Up the Pace of Drug Stability Studies

Ronald A. Rader is senior director, Technical Research, at BioPlan Associates.

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Innovation speeds discovery, drives down costs, and improves productivity.

Top Trends in Biopharmaceutical Manufacturing, 2017

Joanne Sullivan is corporate vice-president, RegulatoryOutsourcing Services at PAREXEL Consulting.

Philip Smith is senior director, Integrated Product Development at PAREXEL Consulting.

Bettina Goldberg is vice-president, Clinical Trials Regulatory Services at PAREXEL Consulting.

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.

How to Get the Most from Regulatory Outsourcing

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

Swiss CDMO Expands GMP Manufacturing Capabilities

Jim Stone is senior sales manager for Anguil Environmental Systems, which specializes in exhaust air purification; jim.stone@anguil.com ; tel: (414) 365-6400 ext 586.  

Regenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems. 
