Also in This Issue

Biologics

Building a Biologics Business from the Ground Up

Building a biologics business from the ground up provides tremendous flexibility but requires the right business strategy.

Hot Melt Extrusion

Leveraging Hot Melt Extrusion for Solubility and Continuous Manufacturing

Hot melt extrusion (HME) technology leads to enhanced solubility.

Mergers & Acquisitions

Inside Mergers & Acquisitions

Innovation and efficiency are both key to successful drug development and commercialization.

Next-Generation Biopharma

Changes in the Biopharma Industry: from Minor to Major Evolution

The biopharmaceutical industry continues to grow rapidly. Targeted biologics are helping treat previously untreatable diseases.

Clinical Trials

Supporting Patient-Centric Clinical Trials from Point-of-Origin through the Last Mile

The clinical trial paradigm has shifted.

Investment

Taking Middle-Market CROs and CDMOs to the Next Level

Smaller outsourcing organizations often need assistance moving to the next level.

Biologic Candidates

Addressing Development Challenges for Complex Biologic Drug Candidates

Biotherapeutics identified as potential drug candidates are increasingly complex.

Viral Vector

Flexible, Mobile, Modular: High-Containment Viral Vector Center of Excellence

Next-generation viral vector and gene therapy manufacturing facilities must be flexible.

Contract Manufacturing Needs

Meeting Biopharma Contract Manufacturing Needs with a Flexible Global Network

As biologic drugs become more complex and sophisticated, biopharmaceutical companies increasingly need the support of contract development and manufacturing organizations (CDMOs) with advanced capabilities and technology platforms that are consistently implemented across scales and geographies.

Multi-Product Facility Manufacturing

Using a Risk-Based Approach to Manufacturing in a Multi-Product Facility

Manufacturing in multi-product facilities affords numerous advantages- and challenges.

GMP

State-of-the-Art Biologics Manufacturing in an Unexpected Location

Biotechpharma UAB, located in Vilnius, is exporting biologic drug substances worldwide.

Cell and Gene Therapy

Overcoming Raw Material and Supply Chain Challenges in Viral Vector Manufacturing

Viral vector manufacturers involved in all stages of clinical-trial-material and commercial product production rely on single-use (SU) technologies.

OSD Facility Design

Modern OSD Facility Design Considerations for Operational Efficiency and Regulatory Compliance

Oral solid dosage (OSD) remains the preferred dosage delivery form for the formulation of many of today’s drug products.

Integration

Strengthening the Outsource Service Offering through Integration

Controlling costs and increasing efficiencies are two fundamental drivers for outsourcing of pharmaceutical manufacturing.

Corporate Social Responsibility

Corporate Social Responsibility as a Driver for Improved Sustainability

The pharmaceutical industry must respond to growing expectations regarding the environmental impact of medicinal products and manufacturing.

Next-Generation Drug Development

Challenges for Next-Generation Biological Therapeutics Discovery and Development

In the last three and half decades, the focus of drug discovery and development has gradually shifted to large, complex molecular entities — therapeutic biologics.

Next-Generation Manufacturing

Thinking a Generation Ahead: Biologics-Based Therapy

Whether dealing with stem cells, CRISPR Cas-9 technology or antibody-drug conjugates, there is no shortage of innovation - the challenge is scaling up.

Next-Generation Packaging

Finishing Touches – The Future of Fill-Finish and Pharma Packaging

Fill-finish has remained relatively stable in spite of myriad developments in the industry over the last decade.

Asset Management

Maximizing ROI through Equipment Liquidation

Cost pressures are significant drivers for pharmaceutical manufacturers seeking to eliminate redundancies and increase productivity and efficiency.

Solid Oral Dosage Drugs

Experience Meets Flexibility

Advances in rapid synthesis technologies are leading to the preparation of new classes of compounds with attractive therapeutic properties.

Oral Peptides

Scientific Expertise Facilitates Oral Peptide Product Development and Manufacturing

Most often developed as injectable formulations, a few “oral peptide” drugs have been approved in recent years.

Controlled Nucleation

Achieving Controlled Nucleation During Aseptic Lyophilization

Controlled nucleation is essential for obtaining high-quality lyophilized products with intra- and inter-batch consistency.

Market Expansion

BioPharma CDMO Success Requires Technical Leadership and Problem-Solving Capabilities

Since their introduction, biologic drugs have shown great potential to treat diseases not possible to remedy with traditional small-molecule drugs.

Fill-Finish Services

Providing Flexible Capabilities to Meet Market Demand for Sterile Fill-Finish Services

The fill-finish step in the manufacturing of drugs is the last step completed before a product is packaged and delivered to the patient.

Substance Control

DOPING – Famous Cases, Substances and Values in Sports

Doping remains a constant threat to the ethics and values in professional sports, as well as on the amateur level.

2018

Issue Q4 2018

The Innovation Issue

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Issue #4 | Volume #4 | Q4 2018
Issue Q3 2018

The Outsourcing Issue

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Issue #3 | Volume #4 | Q3 2018
Issue Q2 2018

The Next-Generation Issue

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Issue #2 | Volume #4 | Q2 2018
Issue Q1 2018

The Executive Issue

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Issue #1 | Volume #4 | Q1 2018