The growth within the field of biologics has been palpable over the past few years and is expected to continue to expand for the foreseeable future. With such a positive outlook, outsourced capabilities may also be able to ride on the crest of the biologics wave, although as reported by Results Healthcare, contract manufacturing organizations (CMOs) may need to consider subsector patterns to take advantage of the market shifts. 

 spoke with Mike Danzi, CEO of Legacy Pharmaceuticals Switzerland, which is a SwissMedic and US FDA-approved CMO, about the challenges facing CMOs in the field of biologics and best practices for working with complex therapies.

	When referring to this article, please cite it as F. Thomas, "Navigating the Biologics Wave," 

BioPharm International's Outsourcing Resources

Articles

Features

Contract manufacturing organizations need to adapt to successfully overcome the specific challenges posed by complex therapies.


Navigating the Biologics Wave

With the biopharmaceutical business model undergoing rapid transformation as the result of disruptive new platform technologies and the need for accelerated biopharmaceutical development growing globally, clinical-stage therapeutic companies are facing complex challenges. A growing trend of partnerships between small biotech companies and CDMOs is also making it increasingly important to conduct CMC due diligence.

	When referring to this article, please cite it as Y. Ding et al., "CMC Due Diligence for Accelerated Biologic Drug Development and Manufacturing," 

BioPharm International's Outsourcing Resources 

The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.

CMC Due Diligence for Accelerated Biologic Drug Development and Manufacturing

Now that high yields have been achieved for the first generation of monoclonal antibodies, the next challenge will be developing ways to produce larger quantities of even more complex antibody formats. These increasingly complex molecules will require the right “tool box” for scaling up manufacturing.

	When referring to this article, please cite it as Andy Racher, "Complex and Customized: Manufacturing New Molecular Formats,"

Increasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.

Complex and Customized: Manufacturing New Molecular Formats

Gene and cell-therapy drugs in development require both novel and conventional test methods within the regulated bioanalytical space. Current FDA guidance, however, provides little direction on how to approach assay development and validation for these emerging technologies. In addition, the authors note that there is limited guidance for the application of more familiar technologies to gene-therapy applications.

	The authors review key methods and complex assays that developers of gene and cell therpies should undertstand to accurately assess the drugs in development. They also explore the expertise that is need to expedite these highly complex therapeutic classes.

	When referring to this article, please cite it as C. Satterwhite, et.al., "Emerging Therapies Test Existing Bioanalytical Methods," 

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

Emerging Therapies Test Existing Bioanalytical Methods

, Richard Rogers, principal scientist at Just Biotherapeutics and formerly a member of the Amgen team that developed and proved the concept behind MAM, describes the story behind the method, how it is moving from quality control testing into drug development, and how it is helping to guide new product and software development. 

	When referring to this article, please cite it as A. Shanley, "Using the Multiple Attribute Method for Process Development and Quality Control," 

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

BioPharm International-04-15-2019

Navigating the Biologics Wave

CMC Due Diligence for Accelerated Biologic Drug Development and Manufacturing

Complex and Customized: Manufacturing New Molecular Formats

Emerging Therapies Test Existing Bioanalytical Methods

Using the Multiple Attribute Method for Process Development and Quality Control