2020台灣生技月 Bio Taiwan 生物科技大展

2020 台灣生技月 南港展覽館

講師

Formosa Laboratories, Inc.

Company Presentations

Wednesday, July 22 Company Presentations 1–Pharma

Formosa Laboratories, Inc.

Company Info

Name /Formosa Laboratories, Inc.

Address /36 Hoping street, Louchu, Taoyuan, Taiwan. 33842.

Website /www.formosalab.com/index.php

Presenter

Name /Joanne Lo

Title /Assistant V.P. FDF Business Development Marketing & Sales

Email /joannelo@formosalab.com

Telephone /(Work) +886 3 324 0895 ext 262

Fax /+886 3 324 0923

Mobile /+886 905 061 637

Company Type

Pharmaceutical

About the Company

Formosa Laboratories offers full-service GMP manufacturing from drug substance to drug product.  Our injectable facility accommodates both small molecules and biologics, from pilot scale to commercial scale, and all under general or cytotoxic control.  Combining this expertise, our platform for Antibody-Drug Conjugate manufacturing is well established. Our service scope includes antibody production (through domestic alliance), to in-house toxin-linker CMC services and antibody bioconjugation, and finally through to cytotoxic fill-finish drug product manufacturing. Formosa Laboratories is fully GMP compliant and has been approved by DOH of Taiwan, US FDA, BGV of Germany, EDQM, and PMDA of Japan.

Brief Description of main products or services

Formosa Laboratories have below strengths and offer the services of one-stop service to customer.

GMP compliance

Inspected by international regulatory authorities, including TFDA, USFDA, EDQM, BGV, PMDA and COFEPRIS.

 

DMFs and CEPs

  • 45 US DMFs on file
  • 12 EU DMFs on files
  • 5 COS on file
  • 12 JP DMFs on file
  • 41 GMP Certificated by DOH Taiwan

 

Globally recognized, volume supplier of high-quality APIs and advanced intermediates.

 

Strategic partner for toll and custom manufacturing projects.

 

State-of-the-art facilities for high-potency APIs.

 

 

Injection

We provide one-stop solutions for sterile injectable drug products to our customers. Our state-of-the-art injectable manufacturing facility and team of dedicated experts are capable to provide services from contract development to commercial manufacturing.

Injectable fill-finish drug product for:

  • Both Small Molecules and Biologics
  • General, Cytotoxic, and High potency drugs
  • Liquid-filled, Lyophilized and Pre-filled syringe products
  • Pilot scale to Commercial scale capacity

 

Aseptic Filling Lines Capability & Capacity:


Antibody drug conjugate

Strategic partner for your success

Fulfill all the needs

  • From R&D process development to process validation
  • From pre-IND scale to commercial
  • From chemical sourcing to CMD documentation
  • From drug substance to drug product

All GMP-compliant

 

Antibody-Drug-Conjugate

Comprehensive range of services

  • Antibody development and manufacturing
  • Linker-payload synthesis and manufacturing
  • Bioconjugation, and purification (TFF, chromatography)

 

Payload Capability

Total synthesis of cytolysin derivativies

From mg to dozens grams

Contact Person

Name /Sophie Yang

Email /sophieyang@formosalab.com

Phone /(Work) +886 3 324 0895 ext 190