JOINN Biologics US Inc.

Company Headquarters

2600 Hilltop Drive
L3015
Richmond, CA 94806
United States

View Phone No.

Company Description

JOINN Biologics US Inc. was founded in 2018 and located in San Francisco Bay Area at the JOINN Innovation Park.

JOINN Biologics is a Contract Development & Manufacturing Organization that provides you a quality and speed to market comprehensive range of services across all phases of the drug life cycle.

Our range of services includes Cell Line Development and MCB Manufacturing, Process and Analytical development, Formulation Development, Drug Substance Manufacturing and Drug Product Development services, along with packaged services for material production and IND enabling PKPD TOX services, all under one quality system supported by global regulatory services.

JOINN Biologics platform supports gene to IND in less than 12 months.

Our scientists and engineers bring over two decades of development experience across a broad spectrum of both platform and novel technologies.

JOINN Capabilities:

Development Services

Developability Assessment

Developability assessment evaluates the drug-like properties of lead candidates at the early stage (i.e. discovery), for the potential of being successfully developed into a stable, manufacturable, safe, and efficacious drug product. It is important to carry out this assessment as early as possible in the pre-clinical stage of development to eliminate candidates that do not present a favorable developability profile. This will minimize the risks of costly late-stage failures and avoid potential issues that may occur during the clinical application of a biotherapeutic.

At JOINN Biologics, a panel of small-scale, fast, and predictive tests are used to evaluate therapeutic antibodies’ developability.

The developability evaluation comprises in silico analysis as well as a series of in vitro assays for the drug candidates, so to provide information about the integrity, purity, aggregation, thermostability, charge heterogeneity, glycosylation, poly-reactivity, potency, stability over low pH and accelerated storage conditions, and potential PKPD profile.

Lower liabilities of deamidation, isomerization, oxidation, hydrolysis in variable especially CDR regions from in silico analysis.

Preferred physico-chemical properties by in vitro analysis
High affinity to target by biosensor
High purity by capillary electrophoresis
Level of degradation, aggregation by size exclusion chromatography
Low heterogeneity by MassSpec
Zero non-specific binding from poly-reactivity assay
High stability over extreme conditions. i.e. low pH, high temp
Preferred glycan profile
Favorable PKPD profile shown by FcRn binding
Acceptable viscosity at high concentration

Cell Line Development

Obtaining a highly productive, single cell derived stable cell line is essential for manufacturing biological drug substance. JOINN Biologics’ highly efficient cell line development process can meet such growing needs and accelerated timelines. Using a combination of high through-put imaging, screening, single cell printing technologies and early product analysis, we are able to evaluate every step in the CHO cell line development process. Our optimized workflow demonstrates successful selection of clonal cell lines with high productivity, high quality and monoclonality.

JOINN offers our customers the access to an experienced cell line development team with choices of two host cell platforms.

JOINN-CHO

JOINN-CHO is a CHO-K1 cell derived, JOINN Bio proprietary cell line development platform for generating biomanufacturing cell lines expressing recombinant antibodies and proteins. The host cell line is well adapted in chemically defined media and grows as suspension to high cell densities, which makes it an ideal choice for cGMP manufacturing of biological products. The traceability of the cell line is fully documented and available.

JOINN-CHO stable cell line development platform comes with an optimized and complete media system and demonstrated superior performance in protein production.

CHOZN® (SAFC)

CHOZN® is a CHO-K1 cell derived, GS knockout cell line developed by Millipore-Sigma. The platform demonstrated robust performance in generation of manufacturing stable cell lines for therapeutic antibodies and proteins. The CHOZN® platform has reasonable, clearly-defined rights for development and commercialization.

Both cell line development platforms use an expression vector carrying Glutamine synthetase gene and two expression cassettes. Media and procedures are chemically-defined and animal-derived-component free.

Process Development

The goal of process development is to establish scalable, robust, and cost-effective processes suitable for the manufacturing (MFG) of biotherapeutics. There are two key parts of the process development: Upstream Process Development and Downstream Process Development. Upstream PD is focused on cell culture to obtain higher productivity, while Downstream PD is focused on efficiently removing impurities and achieving high recovery yield of the products.

UPSTREAM DEVELOPMENT (click here to learn more)
DOWNSTREAM DEVELOPMENT (click here to learn more)

Analytics Development

Analytics provides the information for the quality of the product itself, as well as the levels of impurities. By providing sensitive and accurate analytical data, analytics can help upstream development by performing spent media analysis, or downstream purification by analyzing protein products.

Formulation Development

The Analytics department also design and optimize the formulation of the final product so to achieve sound stability of drug products under various shipping and storage conditions.

Manufacturing

JOINN Biologics Richmond, CA facilities are recommissioned and equipped with new cell culture, solution preparation, downstream purification and filtration systems. We have the following GMP manufacturing components for your biotherapeutic manufacturing needs:

Master cell banking
Upstream GMP manufacturing
Downstream GMP manufacturing
Fill and Finish
Quality Assurance
Quality Control
Documentation to support IND filing.

Whatever the challenge, JOINN Biologics is your solution for clinical and commercial manufacturing.

Support Services

Quality Assurance

JOINN Bio’s Quality team is committed to providing the highest quality products and services to clients.

Our QA system has the following attributes:

Highly experienced team committed to complying with all appropriate regulations.
Quality Management System fully aligned with the applicable regulatory guidelines.
Promote an engaged workplace culture that values continuous quality improvement.
Ensure a suitable quality policy communicated and understood by all employees.
Periodically evaluate and continually improve the effectiveness of the quality system.
Define processes for establishment, regular review, and improvement of quality objectives.
Experienced validation team to lead facility, equipment and process validation projects.
Expertise in managing the qualification of materials, vendors and service providers.
Well-experienced in performing internal/external audits and managing regulatory inspections.

Quality Control

Our QC department has the following capabilities:

Transfer, develop, optimize, and qualify / validate analytical test methods by exceptionally skilled analysts, full test method life cycle support.
Provide in-house analytical testing capabilities to support ongoing cGMP operations.
Perform USP and other compendial monograph tests.
On-site raw material testing and release.
On-site environmental monitoring and trending.
Conduct in-process material and final product release tests.
Develop and execute product storage and stability testing programs; analyze and trend stability data for expiry development and confirmation; qualify / validate stability-indicating test methods.
Reference material production, qualification, and maintenance.
Support process development/improvement and process validation projects (e.g., comparability and forced degradation study design and execution).