Featured Content

The latest issue of BioProcess International focuses on downstream processing, including flexible chromatography media and tentacle ion exchangers. It also includes articles focused on the regulatory landscape for biosimilars and freeze-thaw validation.

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Cell Therapies Supplement

As cell/gene therapies progress toward large-scale viability, demonstrating process control and managing risk come to the forefront, and developers are logically borrowing approaches already established in the larger biopharmaceutical industry. This focused supplement highlights how quality by design (QbD) can help companies achieve cost efficiencies with process analytical technologies (PATs) and smart scale-up planning.

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Downstream Processing

A researcher at MilliporeSigma, the life science business of Merck KGaA, Darmstadt,  Germany, investigates the ability of tentacle ion-exchange media to  remove viruses effectively in monoclonal antibody purification processes.

Viral Clearance in Antibody Purification Using Tentacle Ion Exchangers

Manufacturers strive toward cost-effective purification of target molecules and a high level of confidence that their biologics are safe and not compromised by the presence of endogenous retrovirus-like particles or adventitious viruses (1). Reliable reduction of viral particles throughout downstream purification processes must be ensured through different techniques such as chemical treatment, filtration, and chromatography. Common monoclonal antibody (MAb) purification schemes use both cation- and anion-exchange chromatography steps (CEX, AEX). Although CEX (to remove product- and process-related impurities) is not…

Figure 1: Immunoglobulin G (IgG) structure consists of four polypeptide chains, including two identical light chains (~25 kDa) and two identical heavy chains (~50 kDa). Each light chain consists of one constant domain (CL) and one variable domain (VL), and each heavy chain consists of three constant domains (CH1, CH2, and CH3) and one variable domain (VH). The Fab is the antigenbinding region containing hypervariable or complementarity-determining regions (CDRs), whereas the Fc region is highly conserved across molecular species. The hinge region contains two disulfide bonds and glycosylation (shown as red dots) at CH2 domain of Fc fragment.


Biosimilar Therapeutic Monoclonal Antibodies: Gaps in Science Limit Development of an Industry Standard for Their Regulatory Approval, Part 1

Biosimilars are biologically derived pharmaceuticals intended to have clinical similarity to a legally marketed innovator product when that product’s patent or market exclusivity has expired. By contrast with generic small-molecule drugs, clinical performance of a biologic pharmaceutical is a function of its structural complexity and higher-order structure (HOS). Biomanufacturing controls of such complex products cannot fully ensure chemical similarity between an innovator product and putative biosimilar because minor differences in chemical modifications and HOS can significantly alter a product’s safety…

Figure 1: Affinity chromatography principle: target-specific ligands are chemically immobilized or “coupled” to a solid chromatographic support. The complex mixture that contains the target molecule with impurities is loaded over the affinity column, and the target molecule that has specific binding affinity to the ligands on the resin will bind. Impurities are washed away, and the bound molecule is eluted from the column, resulting in its purification from the original feedstock.

Downstream Processing

Innovative Downstream Purification Solutions for Viral Vectors: Enabling Platform Approaches to Advance Gene Therapies

Over the past decade, gene therapy applications and their importance in the biopharmaceutical industry have been increasing. Gene therapies promise versatile treatment options that could revolutionize and transform medicine. As treatment modalities, they offer the possibility of long-term and potentially curative benefits to patients with genetic or acquired diseases. Gene therapies are designed to treat disease by delivering genetic material that encodes a protein with a therapeutic effect into a patient’s cells. It can be used to replace a missing…