-----

In this issue: News, interviews, and articles on global activity in drug development and contract outsourcing providers, generic drug regulations, advances in heterocyclic synthesis, CAPA, and business news.

Outsourcing
Five Trends Shaping Biopharma Manufacturing Outsourcing
CMOs are becoming sought-after partners as a result of their use of innovative technologies, single-use bioreactors, and other novel bioprocessing services.
>> Read More

New England CRO/CMO Council Debuts
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.
>> Read More

Regulatory Developments
More New Drugs and Faster Approvals
FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through the roof, speeding more new therapies for cancer and critical conditions to patients.
>> Read More

OPQ Sets Stage for FDA’s Realigned Drug Oversight Structure
FDA’s Center for Drug Evaluation and Research implements its reorganization to bolster programs and policies to ensure drug with its “super” Office of Pharmaceutical Quality (OPQ).
>> Read More

FDA Delays Enforcement of Product Tracing Requirements
FDA delays enforcement of product tracing requirements to May 1, 2015, providing trading partners more time to comply.
>> Read More

API Synthesis & Manufacturing
Chinese API and Drug Manufacturer Issued Warning Letter
Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.
>> Read More

Supply Chain
Dual Sourcing and the Single-Use Supply Chain
A break in the supply of single-use materials and systems can disrupt a biomanufacturing process. Dual sourcing can reduce risk, but also open new challenges.
>> Read More

Cardinal Health to Build Facility to Manufacture Bayer Radioactive Therapeutic Agent
Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.
>> Read More

Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity
Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.
>> Read More

Fujifilm Completes Acquisition of Kalon Biotherapeutics
Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.
>> Read More

Paragon Bioservices to Scale Up Protein Manufacturing
Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human.
>> Read More

Cell Therapy Manufacturing Center to be Built in UK
The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.
>> Read More

Hovione’s Loures Facility Completes Successful FDA Inspection
FDA’s pre-approval inspection of Hovione’s facility in Loures, Portugal confirms site to be GMP-compliant.
>> Read More

Webcasts
Enhancing Quality and Process Efficiency Using Continuous Manufacturing Technology for Drug Substance and Drug Product
Tuesday, Jan. 13, 2015  — 11 am EST/10 am CST/8 am PST
Register free: www.pharmtech.com/enhancing
Sponsored by Patheon