Outsourcing Roundtable
As we see more consolidation in the pharmaceutical industry, what is the impact on contract manufacturing and outsourcing trends? What are the key drivers for outsourcing today compared to the past decade? How have clients’ priorities and expectations changed? How can CMOs and CDMOs remain competitive? And what are the attributes of a strategic partnership that benefits both parties? Are there added challenges in outsourcing, especially with increasing globalization in the pharmaceutical industry? What is the future outlook of outsourcing? Experts answer these important questions.

Outsourcing Trends in Europe
Faiz Kermani
The article looks at European manufacturers’ views on outsourcing their manufacturing and development activities, especially in emerging markets such as India and China.

Technology Transfer: A Practical Science
A.G. Damodhar, Sr. Manager Technical Services, Kemwell
The author discusses the many complexities involved in a technology transfer and presents a risk-mitigation plan that may be implemented before the technology transfer process commences.

Outsourcing HPAPI manufacturing
The author provides an overview of the HPAPI market and the increasing demand for HPAPI manufacturing, along with its challenges (e.g., specialist facility and equipment needs, safe handling, preventing cross contamination, etc.). Benefits of outsourcing HPAPI are discussed, including how to choose the right partner to manufacture your product.

Sterile Solutions: How to choose the right CMO
The article looks at the complexity of sterile manufacturing and outsourcing trends, including challenges and key considerations in outsourcing sterile manufacture, what sort of technological capabilities are needed for large and small volume parenterals, clinical and commercial manufacturing, validation, scale up, etc.

Quality Agreements
IPEC’s guidance offers best practices on qualifying suppliers and how to deal with critical issues such as compliance, manufacturing, packaging and labeling, documentation, change control and auditing.