L4: Vaccine and Drug Manufacturing

What are Public-Private Partnerships (PPPs)

Collaborative arrangements between government/academia and pharmaceutical companies that help accelerate drug development

– PPPs bridge the gap between public research and commercial innovation

Public-Private Partnerships (PPPs):

Public sector (government/academia) provides

• Initial funding

• Early discovery

• Basic research

• Expertise in rare diseases / diverse expertise

• Assay development

• Public health goals

Public-Private Partnerships (PPPs):

Private sector (pharmaceutical companies) provides

• Clinical expertise

• Manufacturing capability

• Upscaling

• Regulatory knowledge

• Good manufacturing practice

• Compound collections/libraries

• Advertising and distribution

Benefits of Public-Private Partnerships (PPPs): (5)

• more rapid identification of relevant biological drug/vaccine targets

• better understanding of disease mechanisms and host-pathogen interaction

• research is critiques via peer-review and publication

• de-risks projects

• diversification of funding

Challenges of Public-Private Partnerships (PPPs): (5)

• Differing priorities, timelines and commercial pressures

• IP issues - determining ownership of Ip

• Publication and data-sharing

• Regulatory hurdles and meeting industry standards (e.g., level of documentation)

• Conflict of interest

3 Types of University- Industry Partnerships:

1. PI-led research grand

2. Contract research

3. Collaborative research models

Types of University- Industry Partnerships:

1. PI-led research grant

- supports an investigator’s research without any

restrictions

Types of University- Industry Partnerships:

2. Contract research

– fee-for-service for solving a defined problem (usually higher cost)

Types of University- Industry Partnerships:

3. Collaborative research models

Corporations expressing interest in co-development, risk/share and collaborative research agreements with options

Example of a successful public private partnership

Medicines for Malaria Venture (MMV): estb. 1999 creating affordable, effective antimalarial drugs

Medicines for Malaria Venture (MMV) achievements

1. Coartem Dispersible (2009)

2. Artemisinin-Based Combination Therapies (ACTs)

3. Next-Generation Non-Artemisinin Treatments

4. Triple Artemisinin-Based Combination Therapy (TACT)

All drug and vaccine manufacture needs to be regulated for

1. Assessment

2. Licensing

3. Control of manufacturing

4. Ongoing surveillance of use and identification of problems

5. For review

National drug and vaccine regulatory body in Australia

The Therapeutic Goods Administration (TGA) – Australia

National drug and vaccine regulatory body in America

Centre for Biologics evaluation and Research (CBER) USA, part of the Food and Drug Administration (FDA)

Do all countries have a national drug and vaccine regulatory body

No

Main role of regulatory bodies

Not to determine if they should be made available but to make sure they are safe

The WHO role in global standards of quality in drug and vaccine manufacture (2)

1) WHO Program for International Drug Monitoring

• Since 1963 collated a systematic collection on serious adverse effects called VigiBase

2) WHO Vaccine approval process – good for global distribution agencies and low income countries who lack a national regulatory body

In Aus, once the TGA approval process is finished what can the pharmaceutical companies then do

1. The pharmaceutical company then applies for ‘Market Authorization’

2. Once given the companies can then also apply for government subsidy under either the Medical Benefits Schedule (MBS) or Pharmaceutical Benefits Scheme (PBS)

Good manufacturing Practice (GMP): what is it & who is it laid out by

GMP is a set of regulations, codes and guidelines for the manufacture of therapeutics, vaccines and diagnostics

Establishes a minimum Good manufacturing Process for:

1. Methods used for manufacture

2. Facilities used

3. Controls put in place for manufacture, processing, packing, storage and distribution of therapeutics

GMP standard laid out by the regulatory body - eg. TGA

Good manufacturing Practice (GMP) ensures that

1. Are safe

2. Have appropriate identity, content and strength

3. Meet quality and purity standards

Current GOOD manufacturing Practice (cGMP)

Some Good manufacturing Practices become redundant as technology improves. Use of cGMP ensures a modern approach that is:

❖ Established on risk based assessment

❖ Up-to-date science based policies and standards are implemented

❖ Uses an integrated systems approach

❖ International cooperation and accreditation

One of the features of Current GOOD manufacturing Practice (cGMP) is an integrated systems approach to:

• Quality

• Facilities and equipment

• Materials

• Production

• Packaging and labelling

• Laboratory control

When was the TGA established

1989

The 5 Ps of GOOD manufacturing Practice (GMP)

• People

• Processes

• Premises & equipment

• Procedures

• Products

Current Good Manufacturing Practices (cGMP) basics

• Quality control – product must meet specification

• Quality Assurance – Systems in place to ensure quality and consistency

• Validation- applicable to every stage of the process

• Documentation – record of every step

Difference between quality assurance and quality control

Quality Assurance sets standards in production sequence

Quality control involves checking final product output

How does Vaccine production differ from drug manufacturing

• Vaccines are usually required for large population use as part of federally funded vaccine schedules

• Usually very large manufacturing volume required

• Shelf life often limited –

Three basic stages of vax production

1. Initiation/Expansion

2. Production

3. Purification/finish

How does drug production differ from vaccine manufacturing

• Drugs manufacture has a broad scope of processes.

• Drugs come in a range of different physical forms –

• Oral - Tablets/capsules, Injectables, Transdermal products, Eye drops Inhalants

Drugs formulations contain additional substances to make the finished form called ___

Excipients

Excipients are used to

• Aid in the processing of the drug delivery system during its manufacture

• Protect, support, to enhance stability, bioavailablity and patient acceptability of medicine

• Enhance other attributes of the drug in safety, effectiveness or delivery of the drug in storage or during use