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The Drug Candidate Journey: Phase II

Is it Effective?

Phase II tests the effectiveness of the biomolecule in actual patients with the disease or illness you’re attempting to treat. These years-long (three, on average) clinical trials involve a few hundred volunteers and help determine the drug’s safety, any side effects, and optimal dosing.

Phase II is high stakes, because determining efficacy is critical to obtaining the funding you need to continue testing. Learn more about funding requirements and how to obtain capital here.

Phase II Needs:

Phase II Considerations
  • Funding
  • PD
  • Sale Up
  • Optimization
  • Regulatory
  • Formulation & Stability
  • Analytics
  • Toxicology


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.

Clarification
PmaxTM Constant Pressure Test
Evaluate performance differences between depth filters and/or estimate the large-scale installation area for a specific depth filter.
> Watch our video

Affinity Chromatography
High throughput screening
Identifying optimal cleaning procedures for extended chromatography resin lifetime. > Watch our video

> Try our calculator

CEX Chromatography
High throughput screening
Identifying optimal cleaning procedures for extended chromatography resin lifetime.
> Watch our video

> Try our calculator
 

AEX Chromatography
High throughput screening
Identifying optimal cleaning procedures for extended chromatography resin lifetime. > Watch our video

> Try our calculator

Virus removal
VmaxTM Constant Pressure Test
Determine the sterilizing grade filters and membrane based prefilters capacity and provide sizing for sterilizing grade filters and membrane-based prefilters.
> Watch our video

Managing aggregates in a virus removal step
Learn more about the types of aggregates, considerations for viral clearance studies, and the use of adsorptive prefiltration for aggregate removal are discussed.
> Watch our video

UF/DF
TFF operations best practices
Set up and cassette installation, membrane flushing, Normal water permeability calculation, and more...
> Watch our videos

Managing aggregates in a TFF step
Learn more how careful selection of operation conditions and Tangential Flow Filtration (TFF) system design impacts aggregate formation within the UF/DF process.
> Watch our video

Final Formulation
Development of a high concentration mAb formulation using TFF
Learn more how to develop a high concentration monoclonal antibody formulation to enable subcutaneous administration.
> Watch our video

Managing aggregates in a formulation step
Manage monoclonal antibody aggregation highlighting liquid formulation stability through the use of excipients and the importance of high quality chemicals.
> Watch our video

Sterile filtration
VmaxTM Constant Pressure Test
Determine the sterilizing grade filters and membrane based prefilters capacity and provide sizing for sterilizing grade filters and membrane-based prefilters.
> Watch our video

Chromatography volume and flow rate calculator:
Quickly determine column dimensions and easily convert between flow rates, linear velocity and residence time. Get the recommended compression factor as well as the minimum resin volume required to pack a column easily.
 
 

EMPROVE® Chemicals for Process and Formulation

Buffering agents
pH-adjustment agents
Salts
Detergents
Stabilizers
Tonicity agents

Process Development

Find out where you can get process development services that reduce the time required to get cGMP biomolecules for your clinical trials. Virtual companies, especially, will need the assistance of a contract manufacturing organization (CMO). Learn about outsourcing to Merck.

This reference guide shows our recommendations for 1L-3L and 20L-200L scale process development:

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
Step Product Loading L/m2 20L Scale
Recommended
Configuration
Part # 200L Scale
Recommended
Configuration
Part #
Primary Clarification Millistak+® D0HC 50 L/m2 1 x 1m2 D0HC MD0HC10FS1 5 x 1 1m2 D0HC MD0HC10FS1
Secondary Clarification Millistak+® X0HC 100 1 x 0.55m2 X0HC MX0HC05FS1 2 x 1.1m2 X0HC MX0HC10FS1
Sterile Filtration Millipore Express® SHC 1000L/m2 XL 600 KHGEG006FF3 1 x 10" KHGEG10HH1
Protein A Eshmuno® A 40 g/L 2 x 500 mL 1.20089.0500 10L 1.20089.9010
Sterile Filtration Millipore Express® SHC 1000L/m2 XL 600 KHGEG006FF3 1 x 10" KHGEG10HH1
Cation Exchange Eshmuno® CPX 60 g/L 2 x 500 mL 1.20083.0500 2 x 5L 1.20083.5000
Sterile Filtration Millipore Express® SHC 100L/m2 XL 600 KHGEG006FF3 1 x 10" KHGEG10HH1
Anion Exchange Eshmuno® Q 200 g/L 100 ml 1.20079.0100 2 x 500 ml 1.20079.0500
Sterile Filtration Millipore Express® SHC 1000L/m2 XL 600 KHGEG006FF3 1 x 10" KHGEG10HH1
Virus Filtration Viresolve® Pro 500L/m2 Modus 1.2 VPMD101NB1 2 x Magnus 2.1 VPMG201NB1
UF-DF Pellicon® 3 30kD Ultracel® 50g/m2/hr 0.5m2 cassette P3C030C00 4 x 1.14m2 cassette PcC0301C10
Sterile Filtration Millipore Express® SHC 150L/m2 XL 600 KHGEG015FF3 1 x 5" KHGEG05HH3
Phase II Fast Facts
  • Typical Starting Volume (estimate): 200L
  • Typical timeline (in years): 3
  • Number of batches per molecule: 7

This chart lists common buffers and chemicals for a small-scale mAbs process, moving to Phase II:

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®) 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.

Resources

Parenteral Drug Association (PDA) Technical Reports: #10 Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers (fee applies)

Parenteral Drug Association (PDA) Technical Reports: #53 Technical Report No. 53: Guidance for Industry: Stability Testing to Support Distribution of New Drug Products (fee applies)

  • 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

Unlock your molecule's potential

2018 Advance Biotech Grant Program

We understand the challenges biotech companies face in the quest to push their biological drug candidates to market. We hosted our 2018 Advance Biotech Grant Program, the 5th edition, for European biotech companies, to help you accelerate to clinic faster.

Watch here for the winner announcement. >




Find out more about our programs:
Grants | Events | Innovation | Agreements

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 Merck.
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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