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The Drug Candidate Journey: Pre-Clinical Testing

Safe & Effective

Pre-clinical testing establishes that the target compound is safe and effective – before it can be tested in humans. The in vitro, in vivo and animal testing at this stage can take several years – as many as six.

The goal here is preparing and filing an Investigational New Drug (IND) application.

To cover toxicology and safety studies, prepare for manufacturing considerations, and outline clinical trials protocols, you need capital.

It is also helpful to begin understanding the regulatory requirements – so you’re staying the course and correctly tracking data you’ll need later when filing the IND.

Pre-Clinical Considerations
  • Funding
  • PD
  • Regulatory (IND)
  • Analytics

Preliminary Process Development

Developing monoclonal antibodies (mAbs) that can make the full journey requires excellent science – and excellent tools.
Here is some of the high-tech gear you’ll need to ready your biopharmaceutical for its IND:

Step Product Loading L/m2 1L Scale
Recommended
Configuration
Part # 3L Scale
Recommended
Configuration
Part #
Primary Clarification Millistak+® D0HC 50 L/m2 1 x 540cm2 D0HC MD0HC054H1 2 x 540cm2 D0HC MD0HC054H1
Secondary Clarification Millistak+® X0HC 100 1 x 270cm2 X0HC MX0HC027H1 1 x 540cm2 X0HC MX0HC054H1
Sterile Filtration Millipore Express® SHC 1000L/m2 XL 150 KHGEG015FF3 XL 150 KHGEG015FF3
Protein A Eshmuno® A 40 g/L 5mL column 1.25161.0001 10mL bulk resin 1.20089.0010
Sterile Filtration Millipore Express® SHC 1000L/m2 XL 150 KHGEG015FF3 XL 150 KHGEG015FF3
Cation Exchange Eshmuno® CPX 60 g/L 5mL column 1.25157.0001 10mL bulk resin 1.20083.0010
Sterile Filtration Millipore Express® SHC 100L/m2 XL 150 KHGEG015FF3 XL 150 KHGEG015FF3
Anion Exchange Eshmuno® Q 200 g/L 5mL column 1.25074.0001 10mL bulk resin 1.20079.0010
Sterile Filtration Millipore Express® SHC 1000L/m2 XL 150 KHGEG015FF3 XL 150 KHGEG015FF3
Virus Filtration Viresolve® Pro 500L/m2 Modus 1.1 VPMD101NB1 Modus 1.1 VPMD101NB1
UF-DF Pellicon® 3 30kD Ultracel® 50g/m2/hr 88cm2 device P3C030C00 0.11m2 mini P3C030C01
Sterile Filtration Millipore Express® SHC 150L/m2 XL 150 KHGEG015FF3 XL 150 KHGEG015FF3

Process Considerations

What you should know in pre-clinical testing to smooth the journey to Phase I of clinical trials:

Cell Culture

Learn more how to manage cell line clonality during a process of cell line development for the production of recombinant proteins.
> Watch our video: Demonstration of cell line clonality during the process of cell line development.


Managing aggregates in a mAb process
How upstream unit operations including clone selection, process optimization such as nutrient optimization and oxygen availability can impact monoclonal antibody aggregation in your process.
> Watch our video: Managing Agreggates in your Monoclonal Antibody (mAb) Process: Upstream.


EMPROVE® Chemicals for Process and Formulation

Buffering agents
pH-adjustment agents
Salts
Detergents
Stabilizers
Tonicity agents

Recommended Tools of the Trade

For a small-scale mAbs process that carries you to Phase I, here are some common buffers and chemicals:

Product Pack Size Catalog Number
Sodium Chloride USP, EP, BP, JP (Emprove®) 1kg, 5kg 1.37017
TRIS USP, EP, BP, JPC (Emprove®) 1kg, 5kg 1.08386
Sodium Hydroxide USP, EP, BP, JP (Emprove®) 1kg, 5kg 1.06482
Phosphate Buffer multicompendial (USP, EP etc.; Emprove®) 1kg, 5kg various
Supplements, Amino Acids (Emprove®) 1kg, 5kg various
Stabilizers, multicompendial (Sucrose, Sorbitol, Mannitol; Emprove®) 1kg, 5kg various
The Emprove® program includes over 400 products that meet the latest
regulatory requirements, with 24/7 online access to product information
and dossiers necessary to facilitate the qualification and approval process.
  • Funding

    Primary Need

    Lack of funding is one of the main reasons for failure of a biologic.

    Estimates vary, but some project it costs $8-10 million just to get to IND stage, another $8-10 million for Phase I, and $20-40 million for Phase II, depending on design. Phase III costs considerably more.

    Don’t let a good drug go to waste, or too much of its value to third parties, because of funding issues. There are ways to fund biotech, from biotech crowdfunding, nondilutive funding, and nonsoursive funding, to biotech grants, angel investors, venture capital and other resources.

    More >
  • Intellectual Property

    Intellectual property strategy is essential to protecting ideas and the business. Emerging biotech community members shared their insights.

    More >
  • Regulatory Guidance

    Stay the Course

    On the journey to commercialization, be sure to stay the course by understanding the global pharmaceutical regulatory landscape.

    We offer

    More >

Emerging Biotech: Stay Current

Advance Biotech Grant Program – Accelerating Therapeutic Development in Life Science

The Life Science business of MilliporeSigma is expanding its commitment to the global biotech community with its Advance Biotech Grant Program. Through the newly expanded grant program, every six months, three recipients around the globe will be awarded a total of €200,000 in free services and products to address their process development challenges. In total, six companies will benefit from the Advance Biotech Grant Program each year. Press Release >

The Emerging Biotech Grant Program will launch in the USA in November, 2018. If you are interested, leave your details and we will contact you. Contact us >


Find out more about our programs:

Bringing your molecule to market. As part of our commitment to meet the needs of the life science community, we’ve developed several programs that recognize stand-out emerging biotech companies. These programs are designed to support biotech start-ups and medium sized companies in solving their current bioprocess development challenges to bring the next generation of molecules to market.

More details about EB Programs>

WEBINAR: Venture Capital Funding: An Insider’s View

Learn more about the ABCs of venture capital including how it works and the role of a corporate venture capital.

Watch >


WEBINAR: Accelerated ADC Development with Integrated Supply Chain Solutions

Learn more about the advantages to work with one source on your mAb, linker/ payload supplies and conjugation services.

Watch Now >


WEBINAR: RNA Based Therapeutics and Vaccines: Bioprocessing Technology Trends

Review the current dynamics in the RNA therapeutics/vaccines market with a focus on process development and manufacturing strategies.

Watch this Webinar >


WEBINAR: Managing Process Scale-up and Tech Transfer

Learn more on points to consider for successful tech transfers with a focus on cGMP training requirements.

Watch this Webinar >


Webinars On-Demand >

WHITE PAPER: 2017 Life Science Executive Summit

Establishing an open dialog within the biotech community....

Read more and download >


The Changing Biopharma Risk Equation

A report from the The Economist Intelligence Unit sponsored by MilliporeSigma.
This paper, which incorporates the results of a survey of 254 pharmaceutical executives from around the world and a range of interviews with industry experts, explores in detail global pharmaceutical companies' growth strategies and their plans for managing the associated risks.

Read the study >

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