| EXPRESSION SYSTEMS |

The Search for Next-Gen Expression Systems

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.
read more

| PEER-REVIEWED RESEARCH |

Oral Delivery of Macromolecular Drugs

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.
read more

| PROCESS CONTROL |

Moving Toward Unified Process Control for Biopharma

Traditional barriers between upstream and downstream bioprocessing are slowly starting to break down, as biopharma embraces more advanced analytics and process control.
read more

| PACKAGING|

Selecting Primary Packaging for Parenterals

Traditional glass and polymeric materials compete for market share in primary packaging for parenteral drug products.
read more

| SUPPLY CHAIN |

Serialization: Scaling Down for the Final Stretch

Vendors are offering template-based models and direct data-filing services to help smaller companies meet imminent deadlines.
read more

| FROM THE EDITOR |

Be Quick, But Don't Hurry

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.
read more

| OUTSOURCING OUTLOOK |

Fifteen Years of Progress: Biopharmaceutical Industry Survey Results

This article highlights 15 years of changes in biopharmaceutical manufacturing.
read more

| US REGULATORY WATCH |

Biosimilars Raise Manufacturing and Regulatory Challenges

FDA seeks more efficient testing to spur development of less costly biotech therapies.
read more

| ASK THE EXPERT |

Seeking Regulatory Advice

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
read more