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Better Development Upstream to Ensure Quality Downstream


Process Optimization for Biologics Production:

Enabling Enhanced Production, Efficient Purification, and Preservation of Product Integrity

In the field of biopharmaceutical production, we understand that achieving optimal results is paramount. That’s why we prioritize process optimization to unlock its full potential. Our approach revolves around three crucial aspects: enhanced production, efficient purification, and the preservation of product integrity. Optimizing bioprocess development is critical for overcoming potential challenges stemming from cell stress, cell death, protein aggregation, contamination, and other factors that might impede the reliable manufacturing of the drug. We aim to streamline and enhance your bioprocessing workflow by providing cutting-edge solutions and technologies, leading to more efficient and successful biotherapeutic development.

Maximize Yield

Upstream Bioprocess - Cell Culture/Process Optimization

Maximizing yield in biopharmaceutical production is crucial for optimizing productivity and cost-effectiveness. It involves strategic process optimization, such as enhancing cell culture conditions, optimizing fermentation parameters, and improving downstream purification techniques.

MEGACD40L® Protein (soluble)(human) (recombinant)

High-activity, high-purity CD40L construct for co-stimulatory activation of an immune response without enhancers.

  • Superior purity eliminates experimental artifacts
  • 100-fold lower endotoxin levels than comparable products
  • Reliable results through consistent lot-to-lot performance

Achieve rapid expansion of primary B cells with MEGACD40L® recombinant protein. Using MEGACD40L® in association with other stimulants can improve expansion of primary B cells by 36 fold, based on the work by Hung KL, et al

Enhance Immune Activation with MEGACD40L® Protein

B cell lymphocyte activation by various CD40L constructs. PBMCs were treated for 48 hrs in media containing serially diluted CD40L, CD40L + 2 μg/mL Enhancer, or MEGACD40L® Protein.


Small Molecules and Peptides

Incorporating small molecules into bioprocessing workflows can enhance productivity at various stages of the production cycle. These molecules act as potent enhancers, catalysts, or modulators, driving improvements in yield, quality, and overall process performance.

Our chemistry and compound range includes over 3,000 stand-alone small molecules with known activity, including natural products, enzyme inhibitors, receptor ligands, drugs, lipids, and fatty acids. From metabolic engineering to downstream processing, these compounds offer unprecedented opportunities to enhance productivity, streamline workflows, and achieve greater efficiency in producing valuable biologics.
Product Upstream Downstream
Cell Culture/Processing Process Optimization Scale-up Process Optimization
Autophagy Inhibitors
LY 294002
25-Hydroxyvitamin D3
Caspase Inhibitors
Z-VAD-FMK (ready-to-use)
Cell Culture Supplements
Deoxymannojirimycin HCI
Folic acid
Retinoic acid
HDAC Inhibitors
Sodium butyrate
Immune Response Modulators
Protease Inhibitors
AEBSF (pefabloc® )
Alk5 Inhibitor II
Leupeptin (synthetic)
Pepstatin A

Your Partner in GMP Services

Start Up, Speed Up, and Scale Up Your Discovery

Maintain Product Integrity

Upstream Bioprocess - Purification/Formulation

By monitoring aggregation, product stability can be assessed, allowing for the optimization of formulation and manufacturing processes to meet stringent regulatory requirements. This proactive approach ensures the final biopharmaceutical product maintains its integrity, efficacy, and safety.

PROTEOSTAT® Protein Aggregation Assay

Based on an innovative molecular rotor dye, the PROTEOSTAT® Protein Aggregation Assay is a simple, sensitive, and homogeneous fluorescent microplate assay allowing the detection in solution of a broad range of protein aggregates, from visible to subvisible particles.

  • Delivers superior results when compared to conventional protein detection dyes
  • High-throughput method for monitoring protein stability when used with flow cytometry or microplate reader
  • Provides a convenient, complementary orthogonal method for cross-validation of instrumentation-intensive techniques
  • Useful assay to troubleshoot protein damage, from protein development through manufacturing stages

Related Product
PROTEOSTAT® Protein Aggregation Standards

Reference articles

Optimizing Biologics Formulations.
Here and There on Upstream Processing.

Broadest Detection Range from Visible to Subvisible Particles

Methods to analyze protein aggregation


PROTEOSTAT® Thermal Shift Stability Assay

Based on an innovative molecular rotor dye, the PROTEOSTAT® Thermal Shift Stability Assay is a rapid, simple, and sensitive screening method allowing the end user to investigate proteins’ aggregation propensity by determining the aggregation temperature.

  • Perform accelerated screening for protein stability as a function of pH, ionic strength, and concentration
  • Screen for ligand binding to proteins of unknown function
  • Identify protein-protein interaction inhibitors

Reference article

Here and There on Upstream Processing.

Thermal Shift Stability Assay Kit

Typical results of the PROTEOSTAT® Thermal Shift Stability Assay are shown for goat anti-mouse IgG (11.2 mg/mL at pH 7.4)


Guide to Optimizing Protein Characterization

  • Current Food and Drug Administration Guidelines
  • How to Determine Protein Stability
  • Methods for Detecting Protein Aggregates
  • Development and Specificity of the PROTEOSTAT® Dye
  • Using PROTEOSTAT® for a Rapid Detection and Characterization of Protein Aggregates by Flow Cytometry
  • Detection of Bacterial Aggregates by Flow Cytometry
  • Using PROTEOSTAT® Reagents to Predict Aggregation
  • Propensity and Monitor Aggregation of Antibody-Drug Conjugates (ADC)

Monitor Contamination

Downstream Bioprocess - Process Monitoring/Quality Control

Contamination in biopharmaceuticals can occur at different stages of production and includes sources such as microorganisms, adventitious agents, and chemical impurities. Effective monitoring and control play a critical role in ensuring the safety and integrity of biopharmaceutical products while meeting rigorous regulatory standards.

Protein A ELISA Kit

Protein A ELISA kit is a sensitive and reproducible sandwich immunoassay to quantify Protein A residuals in monoclonal antibody preparations.

  • Highly sensitive measurement, detecting as little as 9.01 pg/ml (<1 ppm) of Protein A residuals in purified humanized mAb preparations
  • Universally used as it recognizes 4 commonly used constructs of Protein A
  • High-throughput format with results in under 3 hours for up to 37 samples in duplicate

Recognition of all Commonly Used Protein A Constructs Ensures Accurate Results

Protein A construct cross-reactivity assessment


Host Cell Protein ELISA Kits

The Host Cell Protein ELISA kits and reagents are ideal for impurity analysis. Quantitatively measure host cell protein contamination in E.coli, CHO, and HEK293T derived products.

  • Sensitive measurement of host cell protein, detecting as little as 10 ng/ml
  • High protein coverage greater than 70% thereby, reducing the risk of missing potential contaminants
  • High-throughput format with results in as little as 3 hours

CHO Host Cell Protein ELISA kit
E.coli Host Cell Protein ELISA kit
HEK293T Host Cell Protein ELISA kit

Related Product
CHO HCP Standards
E.coli HCP Standards
HEK293T Host Cell Protein Standards

Sensitive Measurement of HCPs

Typical standard curve for CHO HCP ELISA Kit



7 Simple Tools For Maximizing Your Bioprocess Pipeline

Are you in the bioprocessing field?
If so, let Enzo help you navigate the daunting quality control aspects of your operation by providing 7 simple tools to maximize your bioprocess pipeline. Whether you work in drug discovery, upstream, or downstream bioprocessing, Enzo offers a range of products to help you optimize product integrity, monitor contamination, and maximize yield.

Who should attend this webinar?
Anyone in the bioprocessing field who wants to know more about characterizing their biologic, protein aggregation, formulation optimization, storage and packaging of their biologic, and how to monitor and detect contamination.

Why should you attend this webinar?
To ensure that you are optimizing your bioprocess pipeline to facilitate rigorous and reproducible quality control in order to produce the highest quality product while consistently and reliably scaling your operation.

Presented by: Heather Brown, PhD
Application Scientist

Topic: Bioprocess

Improved Screening for Biotherapeutic Candidates

Improve Pharmacokinetic Analysis - PEGylated Protein ELISA Kit

The sensitive PEGylated Protein ELISA kit is ideal for drug development and pharmaceutical manufacturing applications including drug formulations, pharmacokinetics analysis, drug comparison, lead candidate identification, lot release criteria and in-process QC studies.
  • Validated for a wide range of MW linear and branched PEGs, both in free form and when conjugated to proteins
  • Sensitive assay measures < 1ng/ml of PEGylated molecules
  • Quantifies PEGylated target molecules in complex matrices to allow monitoring of drug levels or its accumulation in tissue
  • High throughput format allows analysis of up to 35 samples in duplicate in just 2 hours

Related Products
Protein Carbonyl ELISA Kit
Transferrin ELISA Kit

Sensitive detection of linear and branched PEG molecules

Determine Organ-Specific Toxicity - SCREEN-WELL® Toxicity Libraries

Targeted SCREEN-WELL® libraries for cardiotoxicity, hepatotoxicity, hematopoietic toxicity, nephrotoxicity and myotoxicity contain compounds with defined and diverse organ-associated toxicity profiles. A variety of structurally and mechanistically different compound classes are included, as well as non-toxic controls. Compounds are dissolved in DMSO at 10 mM and aliquoted into deep-well plates at 100 or 500 μL per well. The libraries are useful for predictive toxicology screening, including high-content protocols.
  • Better understand mechanisms of toxicity with your small molecule or candidate-drug of interest
  • Compare your compound with known references for investigative toxicity
  • Optimize formulation efficacy and safety

Complete Solutions for Process Optimization

Simplify Your Cell Death Analysis

CYTO-ID® Autophagy Detection Kit 2.0

  • No transfection required
  • Brighter, more photostable dye specifically stains autophagic vesicles
  • Rapidly quantifies autophagy in native heterogeneous cell populations
  • Negligible staining of lysosomes reduces background

GFP-CERTIFIED® Apoptosis/Necrosis Detection Kit

  • True multiplexing capabilities with GFP and other green fluorescent probes
  • Readily distinguishes between healthy, early apoptotic, late apoptotic, and necrotic cells
  • Optimized for both fluorescence microscopy and flow cytometry

Sensitive Assays For Oxidative Stress

ROS-ID® Total ROS/Superoxide Detection Kit

  • Distinguishes between different reactive species, such as hydrogen peroxide, peroxynitrite and hydroxly radicals
  • High sensitivity, specificity and accuracy for live cell studies
  • Complete set of regents, including ROS inducers and scavengers
  • Validated on microscopy, flow cytometry, and microplates

MITO-ID® Membrane Potential Cytotoxicity Assay Kit

  • 10x more sensitive than JC-1 with superior aqueous solubility
    • Photostable dual-emission dye
        Separate MITO-ID® Red/Green assays available for detection of mitochondrial mass
          Suitable for high-throughput applications

Related Literature and Documents

Featured TechNotes

Are biosimilars really similar?
2014 October 3 | Tags: Bioprocess

Featured Literature


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