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2805, 2019

Patenting Physical Forms in the Pharmaceutical Industry

By |May 28th, 2019|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , , |0 Comments

Using intellectual property laws to secure physical form patents for new drugs first made headlines some thirty years ago. These attention-grabbing lawsuits centered around paroxetine (Paxil), ranitidine (Zantac), and other blockbuster drugs. Generics were attempting to secure exclusive FDA approval for their Abbreviated New Drug Application (ANDA) without invalidating or [...]

2805, 2019

Optimizing Upstream and Downstream Processes in Biologics Manufacturing Yields Significant Savings

By |May 28th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

Pipeline enhancements increase biologic yields while lowering costs. Bioprocessing involves utilizing cultured cell lines to procure biological products. Pharmaceutical bioprocessing is often used to produce proteins such as monoclonal antibodies (mAbs), gene therapy vectors, and other innovative treatments. Due to the natural difficulties of handling biological materials, bioprocesses frequently fall [...]

2805, 2019

Injectable Biologic Formulation Has Developed Substantially in Recent Years, but Several Major Challenges Remain

By |May 28th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

Injectable biologics have some of the heaviest regulations of any pharmaceutical therapy. The US Food and Drug Administration (FDA) insists that anti-contamination protocols be followed throughout the manufacturing and packaging processes, with all personnel, equipment, and manufacturing and lab environments kept completely sterile. Compliance with good laboratory practices (GLP) and [...]

2805, 2019

Despite Individual Fluctuations, the Collective Success Rate of Monoclonal Antibody Therapies Continues to Rise

By |May 28th, 2019|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , , |0 Comments

In terms of clinical studies, the human monoclonal antibody (mAb) sector is expanding faster than any other class of mAb therapeutics. The “chimeric” quality of some mAbs allows for a range of exciting developments. Many combine human DNA sequences with those of rodents or strands found in bacteriophage viruses, choosing [...]

1505, 2019

Quality Control in Commercial Tablet Manufacturing

By |May 15th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

Two out of every three prescriptions in the United States are administered via solid dose form, and nearly 50% of these solid dose prescriptions are administered in the form of compressed tablets. This makes compressed tablets the single most popular dosage form in the world. While many factors contribute to [...]

905, 2019

Emerging Alternatives to Animal Models for Toxicology Testing

By |May 9th, 2019|Categories: Preclinical|Tags: , , , , |0 Comments

The subject of animal testing by the pharmaceutical industry is a contentious one. While no one could reasonably dispute the countless advances that in vivo testing has made possible, the potential ethical ramifications are still hotly debated. Nevertheless, Pharmacokinetic (PK) and Toxicokinetic (TK) studies rely heavily on animal models. Yet [...]

805, 2019

Best Practices Extend Beyond GLP for Investigational New Drug (IND) Enabling Studies

By |May 8th, 2019|Categories: Generic & Commercial Drug Manufacturing Services, Uncategorized|Tags: , , , , |0 Comments

The development of any new drug or biologic requires extensive research and rigorous testing at every stage of the process. After the preliminary development and in vitro or in vivo testing, a proof of concept is finalized prior to clinical testing. If the product contains any amount of heretofore unapproved [...]

1604, 2019

Clinical Trial Material Manufacturing in an Age of Increasing Regulatory Oversight

By |April 16th, 2019|Categories: Formulation Development & Clinical Trial Materials, Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

Building a well-oiled clinical trial supply chain that fulfills the requirements of Phase I and II pharmaceutical clinical trials does not happen by accident. It is universally understood that clinical trial material (CTM) manufacturing demands a commitment to Good Clinical Practice and current Good Manufacturing Practice (cGMP). These guidelines were [...]

704, 2019

Coating Processes in Commercial Tablet Manufacturing

By |April 7th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

The use of the medicinal tablet dates back to ancient Egypt, making it one of the earliest pharmaceutical dosage forms. These solid compounds of active substances and excipients are often covered in some form of superficial coating material. The application of a polymeric film or sugar coat to a tablet [...]