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Categories

Therapeutic applications

Directories

Expertises

Directory of Antibodies, Recombinant proteins and others

Target selection & validation

Gene / protein discovery

bioinformatics design

Expression and pathway analysis of target

quantification of target

Assay development in in-vitro & in-vivo models

Research exploratory companion biomarkers

Hit discovery

Screening & Identification

Therapeutic libraries

In silico

In-vivo models

In-vitro & ex-vivo models

Indication searching

Bioinformatics prediction & analysis

Immunotherapy lead generation

Biophysical profile

Binding & Affinity

Potency & Specificity

Epitope mapping

Functional effects

ADCC, ADCP & CDC

Antigen density target

Internalization

Pharmacology & Biological activity

PK/PD bioavailability

Mode of Action

Therapeutic efficacy

Safety

Immunogenicity

Hypersensitivity & allergies

Immunotoxicology

Specificity

Manufacturability

Production quality

CMC feasibility

Cell activation

Avidity testing

Cell-based activation (APCs, AAPCs)

Bead-base activation

Antibody-based activation

Ex-vivo activation (cell transfer)

In-vivo activation (in human transgenic mouse models)

Gene modification / Transduction

Retroviral & lentiviral vectors

Transposon/transposase

mRNA electroporation

CRISPR/Cas9

Immunotherapy lead optimization

Engineering

ADC

Linkers

Payloads

Protein scaffolds

Fragments

Multi-, bispecific

Fc-fusion proteins

Indication Prioritization

Antibody humanization

Affinity maturation

Proof of concept

Pharmacology potency

Exploratory toxicology

in-vitro & ex-vivo models

in-vivo models

Cell expansion

Gas permeable bags

G-Rex bioreactors

Wave-mixed bioreactors

Preclinical biomarkers

Mechanism/Function

Mechanism of action

Safety

PK/PD features

Indication Identification

Exploratory toxicology

Drug-Target interaction

Level of response duration

Specificity

Surrogate markers

Research exploratory Companion biomarkers

Bioinformatics design

Bioinformatics prediction & analysis

Animal biomarkers

Human biomarkers

Predictive biomarkers

Treatment efficacy

Population stratification

Risk/benefit profile

Disease progression / follow-up

CMC

GLP compliance

Master Cell Bank

Production

Cell Line development

Clone selection

Characterization

Storage

Analytical development

Cell Culture

Media composition

Bioreactor conditions

Gene modification / Transduction

Retroviral & lentiviral vectors

Cell expansion

Wave-mixed bioreactors

Stirred tank reactors

Bioproduction

Batches production type

Mammalian

Insect

Yeast

Bacterial

GLP compliance

GMP compliance

Pilot Batches

Tests

Optimization

Scale-Up process

Process optimization & validation

Volume

Preclinical / Tox

Low volume (< 200 L)

High volume (200 – 2000 L)

Very high volume (> 2000 L)

Commercial

USP (Scale-Up)

Cell expansion

Inoculation

Low volume containers to Bioreactors

DSP (Recovery)

Harvest

Filtration

Purification

Fill & Finish

Aseptic filling

Lyophilization

Batch release

Storage matter

Instruction

Logistic

Cell cryopreservation

Controlled-rated freezer

thaw

Quality assurance, quality control & analytical process

Stability Assessment

Physical & chemical profile

Shear/shaking

Viscosity

Photostability

Freeze/thaw

Heat/degradation

Aggregation

Cell line analytical development

Host cell proteins

Viral clearance

Contaminants detection

Biosafety & Bioanalysis

Toxicology

PK/PD features

Impurities detection

Bioproduction analytical test

Monitoring

Characterization

Batch consistency

Batch release test

Chemical, physical, biological test

Quality control test support

Post-production test

Real-time stability test

Formulation

Dose

Stability

Excipients

Adjuvants

Sterilization

Lyophilization

Storage stability

Delivery

Route of Administration

Devices associated

Clinical trials

Phase I

Phase II

Phase III

Phase IV

Clinical biomarkers

Predictive biomarkers

Treatment efficacy

Population stratification

Risk/benefit profile

Disease progression / follow-up

Safety

PK/PD features

Surrogate markers

Disease progression monitoring

Regulatory filing

Regulatory Filing

Companion biomarkers

Pharmacology

Treatment efficacy

Treatment monitoring

Toxicity

Post-market surveillance

Post-Market Surveillance

Cell Therapy Directory

Cell origin

Single donor

Pool of donors

Cell Banking

IPs

MSC

CD34 + HSC cells

Tissue acquisition

Off the shelf

Apheresis

Target cell isolation

iPS reprogramming

Differentiated Cell

Production Cell

Safety donor-derived therapies

Cell modification

Direct reprogramming

Cell Activation

Ex Vivo & In Vivo Strategy

CMC/analytical quality assessment, quality control

Cleaning

Cross contamination

Sterility

Deviations

Contaminants detection

Safety for gene-edited cells

translocation

anti-nuclease response

cytokine-independent growth

Bioproduction engineering

Cell Expansion

Stirred tank Bioreactor

Wave bioreactor

Cell factory

Microcarrier-based culture

Organoids culture

Capsules culture

Scale-Up

Process optimization

Automated manufacturing

On-line monitoring

Automated high throughput microbioreactor system

Non-GMP expansion

GMP expansion

Other

Purification/Extraction

Filtration / microfiltration / ultrafiltration

Centrifugation

Chromatography

CGMP

Bioproduction modeling

Metabolic / Kinetic modeling

Control / command

Global optimization

Economic analyses

Artificial Intelligence tools

Formulation

Conditioning

Storage

Delivery

Transport

Supply chain logistics

Tracking process

Monitoring logistics

Gene and CAR-T cell therapy Directory

Target Identification

Gene / protein discovery

bioinformatics design

Expression and pathway analysis of target

quantification of target

Assay development in in-vitro & in-vivo models

Research exploratory companion biomarkers

Gene Cloning

Gene augmentation

Gene inhibition

Killing Gene

KI / KO

(Gene) engineering

CRISPR activation

CRISPR interference

TRAC gene editing

TALEN

Gene Delivery System

Lentivirus

Other Retrovirus

Adeno-Associated Virus (AAV)

Adenovirus (ADV)

Gene Gun

Electroporation

Lipid chemical methods

Protein chemical methods

Mixed chemical methods

Inorganic methods

Biomarker Identification

Research exploratory Companion biomarkers

Bioinformatics design

Bioinformatics prediction & analysis

Binder Generation

Mouse immunization

Phage Display

In silico

Hybridoma

CAR Construction

Intracellular Domain

T-cell activation/transduction

Engineering

Tandem CAR

iCAR

Ab-coupled TCR (ATCR)

Modulation of CAR potency

Adoptive T Cell Major Challenges in Solid Tumors

Tumor/Ag heterogeneity

Tumor associated Antigen

Microenvironment

Delivery/homing

Combinations

Persistence of CAR-T

In vivo proliferation and activation of CAR-T

Accessibility of tumor cells

Cell procurement

Autologous

Ex Vivo & In Vivo Strategy

Bioproduction/CMC/Analytical Quality Assessment, Quality Control

Bioproduction

Scale-Up

Automated manufacturing

Automated high throughput microbioreactor system

Supply chain logistics

Tracking process

Monitoring logistics

Non-GMP pilot batch

GMP batch

Cleaning

CGMP

Cross contamination

Sterility

Deviations

Quality control

Contaminants detection

Safety for gene-edited cells

Translocation

anti-nuclease response

cytokine-independent growth

Prophylactic Vaccines Directory

Antigen identification, selection, optimization, and validation

Omics analysis

In silico modeling

Structure-based antigen design

Reverse vaccinology

Epidemiology analysis

Antigen expression systems

Assay development with in-vitro & in-vivo models

Antigen characterization

Antigen optimization:

Generation of mutants

Early purification

Early formulation

Antigen selection: pathogen sequencing and functional antigens

Surface glycoproteins

Strongly immunogenic

Mutation variability

Membrane antigens

Outer-membrane proteins (OMP), toxins

Internal protein

Less immunogenic

Conservative sequence

Immunogenicity in relevant animal models

Pathogen-host knowledge

Pathogen genetics and mechanism of action

Biomolecular analysis

In-vivo expression during pathogen cycle

Host interaction (infection mechanisms)

In-vitro and in-vivo models

Antigen-protective immune-response profile

Humoral response characterization:

Antibody dosage

Functional antibody assays (neutralization, CDC, ADCC)

Other serological assays

Cell mediated immunity response

T cell assays

Reactogenicity Assessment

Research exploratory biomarkers

efficiency vaccination

protection correlation

Vaccine: antigen format platforms

Recombinant protein expression

Bacterial

Cell

Fungi

Synthetic Peptides or oligomers

Virus-like particles (VLP) and nanoparticle-based carriers

Killed/inactivated virus

Live attenuated virus

Viral vector encoding target antigen

DNA plasmid vaccine

mRNA vaccine

Lipid delivery vehicle

Outer-membrane vesicles (OMV)

Polysaccharides/ conjugated vaccines

Other

Challenge test – Gold Standard

In-vivo animal models

Induced immune response characterization

In-vitro models

Ex-vivo models

CMC

GLP compliance

for preclinical NCS (non-clinical safety) studies

viral safety testing

GMP compliance

Master Banks (cell and viral as needed)

manufacturing

Characterization and testing

storage

shipment

Cell Culture / Fermentation

media formulation and supply

Bioreactor conditions (cell in suspension, adherent cell player)

Ability to work in BSL2 conditions

Cell expansion

Single use technology (SUS)

Wave-mixed bioreactors

Stirred tank reactors

Gene modification / Transduction

Molecular biology

Expression systems

Formulation

Adjuvants

Stabilization

Excipients

Vaccines Combination

Lyophilization

Shipment Monitoring

Vaccine delivery/Administration routes

Route of Administration

Intramuscular route

intradermal route

Nasal route

Mucosal routes

Other devices: specify

Delivery/ Encapsulation

Polymeric Nanoparticles

Lipid Nanoparticles

Nano emulsions

Adjuvanted delivery systems

Regulatory safety

Specificity

Human sequence homologies

Regulatory safety tests

Viral safety

Hypersensitivity

Immunotoxicology

Clinical trials

Phase I

Phase II (human challenge trials)

Phase III (large population pending pathogen prevalence)

Immune monitoring

Data management

Bioproduction GMP

Vaccine platform type

Recombinant protein expression

Synthetic Peptides or oligomers

Virus-like particles (VLP) and nanoparticle-based carriers

killed/inactivated virus

Live attenuated virus

Viral vector encoding target antigen

DNA plasmid vaccine

mRNA vaccine

Lipid delivery vehicle

Outer-membrane vesicles (OMV)

Polysaccharides/ conjugated vaccines

Other

Pilot Batches scale

Process development & optimization

Scale-Up & Validation

Comparability characterization protocol

Manufacturing Volume

Small volume (< 100 L) adjusted to phase I/II needs: specify volume

Large volume (100 – 1000 L) adapted for phase III needs

Final scale up volume (> 1000 L) and validation for manufacturing

Commercial supply during life cycle management

USP (Scale-Up)

DSP (Recovery)

Fill & finish

Lyophilization

Prefilled syringe

Vaccine shipment and distribution

Storage matter

Labelling

Packaging for shipping

Instruction Label

Digitalization of bar code

Cold chain logistics

Quality control & analytical process monitoring

Stability Assessment

Biosafety & Bioanalysis

Toxicology

Immune response characterization

Viral safety

Bioproduction analytical monitoring

Key and critical process parameters (KCP, CPP)

Identification

Monitoring

Batch release test

Chemical, physical, biological testing

Potency assay

Challenge animal models

Impurities detection

Quality control test support

Regulatory Filing

New Drug Application (IND)

Investigational Medicinal Product (IMPT) for clinical investigations (EMA)

Common Technical document (CTD) section 3 (CMC) 4 (NCS) and 5 (Clinics) for submission

Post-market surveillance

Clinical Trial phase IV

Immune monitoring

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