Outsourcing

As pharma models changed during the past 40 years, contract manufacturing capacity and services evolved to meet demand.

The more pharma science and technology change, the more business and policy concerns stay the same.

SK Biotek plans to operate the Swords, Ireland API manufacturing facility as a contract development and manufacturing site.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

USP describes analytical and microbiology testing required for different types of pharmaceutical water.

Cambrex announces expansions of its North Carolina API pilot plant and Kalskoga, Sweden large-scale manufacturing facility.

Increased capacity at PPD’s Richmond, VA laboratory are designed to support customers’ vaccine development programs.

Expanded storage capacity at the SGS laboratory in Mississauga, Canada increases stability testing capabilities.

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.

Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter’s primary role will be in the fill and finish aspect.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

The company expanded its UK storage facility to meet increasing demand from its growing customer base.

The company installed the FlexFactory to support its biosimilar production.

The compendium provides a resource to identify and locate targeted suitable patient-derived xenografts based on specific histology and molecular properties.

The new storage and distribution facility provides PCI with additional space, complementing its existing footprint currently used for specialist clinical-trial logistics as well as packaging, labeling, and qualified person activities for investigational medicinal products.

Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.

Catalent has been working together with Lexicon to develop the drug formulation of Xermelo, which has now been approved by FDA for the treatment of carcinoid syndrome diarrhea.

The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.

The company invested approximately $26 million to update its sterile pharmaceutical and development service suites.

The company has formed a Pediatric Center of Excellence in support of the development and manufacture of dosage forms for pediatric indications.

New incubators, instrumentation, and staff will increase cell bioassay capabilities for EAG Laboratories.

CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.

Sharp acquired the pharmaceutical packaging facility in Bethlehem, PA.

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

FDA is in the center of the debate over developing and pricing new cancer therapies.

New study shows China biopharma companies face staffing shortages.

Advances in process analytical technology have been achieved, but significant challenges remain.

A case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.

RSSL has added new equipment for measuring the surface area of powder particles, which is important for determining the performance of excipients and APIs.

The company has secured an additional facility in Hampton, Middlesex, as part of a project to expand its UK-based operations by 15% in 2017.