APIs and Excipients

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.

Advances in process analytical technology have been achieved, but significant challenges remain.

This article summarizes the evolution of the viscosity standards and their corresponding applications in the USP−NF compendia.

A case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.

RSSL has added new equipment for measuring the surface area of powder particles, which is important for determining the performance of excipients and APIs.

Excipient manufacturer adds three tablet binding and disintegration products.

Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.

The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.

FDA issued approvals for less than half the number of new drugs in 2016 compared with 2015.

New website allows access to research quantities of commercial-grade ligands and catalysts.

Alternatives to expensive palladium catalysts are gaining acceptance for commercial API synthesis.

As of mid-December, less than half the number of new drug approvals were issued by FDA in 2016 compared with 2015.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

Saneca Pharma has received a EUR1.5 million grant from the Slovak Ministry of Education, Science, Research, and Sport, which will be used to drive forward new R&D initiatives for API manufacturing.

Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.

Non-precious-metal catalysts are increasingly employed for commercial API synthesis.

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

New catalysts show promise for pharmaceutical intermediate and API synthesis.