Building a biologics business from the ground up provides tremendous flexibility but requires the right business strategy.
Hot melt extrusion (HME) technology leads to enhanced solubility.
Innovation and efficiency are both key to successful drug development and commercialization.
The biopharmaceutical industry continues to grow rapidly. Targeted biologics are helping treat previously untreatable diseases.
The clinical trial paradigm has shifted.
Smaller outsourcing organizations often need assistance moving to the next level.
Biotherapeutics identified as potential drug candidates are increasingly complex.
Next-generation viral vector and gene therapy manufacturing facilities must be flexible.
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.
Manufacturing in multi-product facilities affords numerous advantages- and challenges.
Biotechpharma UAB, located in Vilnius, is exporting biologic drug substances worldwide.
Viral vector manufacturers involved in all stages of clinical-trial-material and commercial product production rely on single-use (SU) technologies.
Oral solid dosage (OSD) remains the preferred dosage delivery form for the formulation of many of today’s drug products.
Controlling costs and increasing efficiencies are two fundamental drivers for outsourcing of pharmaceutical manufacturing.
The pharmaceutical industry must respond to growing expectations regarding the environmental impact of medicinal products and manufacturing.
In the last three and half decades, the focus of drug discovery and development has gradually shifted to large, complex molecular entities — therapeutic biologics.
Whether dealing with stem cells, CRISPR Cas-9 technology or antibody-drug conjugates, there is no shortage of innovation - the challenge is scaling up.
Fill-finish has remained relatively stable in spite of myriad developments in the industry over the last decade.
Cost pressures are significant drivers for pharmaceutical manufacturers seeking to eliminate redundancies and increase productivity and efficiency.
Advances in rapid synthesis technologies are leading to the preparation of new classes of compounds with attractive therapeutic properties.
Most often developed as injectable formulations, a few “oral peptide” drugs have been approved in recent years.
Controlled nucleation is essential for obtaining high-quality lyophilized products with intra- and inter-batch consistency.
Since their introduction, biologic drugs have shown great potential to treat diseases not possible to remedy with traditional small-molecule drugs.
The fill-finish step in the manufacturing of drugs is the last step completed before a product is packaged and delivered to the patient.
Doping remains a constant threat to the ethics and values in professional sports, as well as on the amateur level.