• cGMP clinical manufacturing

• Process development and optimization

• Process scale up and transfer

• Method development and transfer

• Regulatory filings

Proven Regulatory Track Record

TRUSTED PARTNER. QUALITY SOLUTIONS. RELIABLE RESULTS.

EARLY DEVELOPMENT LATE CLINICAL TO COMMERCIAL

FURTHER DEVELOPMENT TO CLINICAL

• Cell line development collaborations

• Cell line optimization

• Process creation

• Preclinical study material

• Process characterization

• Method validation

• Protein characterization

• Process validation

• Commercial manufacturing

Full Lifecycle Capabilities — From Concept to Commercial Supply

Avid manufactures bulk drug substances for products that are approved and marketed in over 18 countries by leading biopharma companies.

We are compliant with worldwide requirements for commercial production regulated by US FDA, EUANVISA, Canadian Health Authority and Australian Department of Health.

• Successful PAIs in 2005, 2012, 2014, 2015 & 2017

• 2018 FDA Inspection Resulting in Zero 483 Observations

• Over 14 years of successful inspection history

Our regulatory team has extensive experience in developing a regulatory strategy and approach, drafting responses and assisting in formulating strategies for interactions with regulatory authorities. We offer a range of services, including:

• Comparability Assessments

• Amendments & Supplements

• CMC Gap Analysis

• IND/BLA/IMPD Submissions

• Assistance with Response to FDA Questions

Established CDMO with 25 Years of Biologics Manufacturing Experience

Excellence in Process Science

Contact: Tracy Kinjerski | 714-600-3904 | E: tkinjerski@avidbio.com | www.avidbio.com

TRUSTED PARTNER. QUALITY SOLUTIONS. RELIABLE RESULTS.

• Demonstrated expertise in cell culture development, with proven ability to maximize productivity and guide glycosylation

• World-class purification experience, with knowledge to provide the chromatography media and methods that will give you the highest productivity and product quality

• Full spectrum analytical capability, with extensive experience and technical knowledge required to develop difficult assays, including live-cell assays

• Highly experienced in rapid technology transfer and process validation

• More than a decade of experience developing processes for smooth scale-up and transfer to cGMP manufacturing

• cGMP manufacturing since 1993

• 12,000 ft2 facility

• Stainless steel bioreactors (100L, 300L & 1,000L)

• WFI, RODI, clean steam

• Raw material storage

• Single-use bioreactors (200L & 1,000L)

Commercial Manufacturing Facility Since 2005

Franklin Commercial Facility

Bioreactor Capacity

SINGLE-USE

3 X 2,000L

4 X 200L

2 X 1,000L

• Commissioned in 2016

• 42,000 ft2 facility

• Equipped with 200L, 1,000L & 2,000L Single-use bioreactors

• Uni-directional process flows for personnel & materials

• Integrated QC labs for in-process samples, final release, & environmental monitoring

• Controlled raw material warehouse

• Modular clean room design

• MCB & WCB storage

State-of-the-art Myford Facility

Designed for Fully Disposable Manufacturing Processes

Bioreactor Capacity

STAINLESS STEEL SINGLE-USE

1,000L

300L

100L200L

1,000L

Our team has experience operating multiple single-use systems as well as transitioning from traditional stainless steel to stirred tank single-use bioreactors.